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and its subsidiaries unless stated otherwise or the context otherwise indicates.
−Removed: We are a clinical-stage medical dermatology company focused on identifying, developing, and commercializing innovative pharmaceutical product candidates for the treatment of medical and aesthetic skin conditions and diseases we believe represent significant market opportunities because current therapies are inadequate or non-existent.
−Removed: Dermatological diseases such as acne vulgaris (or acne), psoriasis vulgaris (or psoriasis), papulopustular rosacea (or rosacea), hyperhidrosis and various aesthetic indications, affect millions of people worldwide each year, and may negatively impact their quality of life and emotional well-being.
+Added: We are a clinical-stage medical dermatology company focused on identifying, developing, and commercializing innovative pharmaceutical product candidates for the treatment of medical and aesthetic skin conditions and diseases we believe represent significant market opportunities.
+Added: Dermatological diseases such as acne vulgaris (or acne), psoriasis vulgaris (or psoriasis), hyperhidrosis, and various aesthetic indications, affect millions of people worldwide each year which may negatively impact their quality of life and emotional well-being.
While there are multiple current treatment options for these indications on the market, we believe that most have significant drawbacks, including underwhelming efficacy, cumbersome application regimens and varying negative side effects, all of which we believe lead to decreased patient compliance.
−Removed: While a majority of these indications are first treated with topical products, many patients frequently switch treatments or discontinue treatment altogether due to patient dissatisfaction stemming from slow and modest response rates, early onset of negative side effects, onerous application schedules and typically long duration of therapy.
−Removed: For diseases like psoriasis, a small percentage of patients may be candidates for biologic or systemic therapies, but these patients are typically required to try topical or oral treatment options prior to qualifying for these expensive biologic or systemic therapies.
−Removed: Given the limitations with current topical therapies and the restricted usability of biologic and systemic therapies, we believe there is a significant opportunity to address the needs of frustrated patients searching for topical products that satisfy their dermatological and lifestyle needs.
+Added: A majority of these indications are first treated with topical therapy, however, many patients frequently switch treatments or discontinue treatment altogether due to patient dissatisfaction.
+Added: This is primarily due to slow and modest response rates, early onset of negative side effects, daily application schedules and long duration of therapy.
+Added: Given the limitations with current topical therapies, we believe there is a significant opportunity to address the needs of frustrated patients searching for topical products that satisfy their dermatological and lifestyle needs.
Our two product candidates, DMT310 and DMT410, both incorporate our proprietary, multifaceted, Spongilla technology to topically treat a variety of dermatological conditions.
−Removed: Our Spongilla technology is a multifactorial, naturally-derived product that is processed from a naturally grown freshwater sponge, Spongilla lacustris or Spongilla , which is processed into a powder that is mixed with a fluidizing agent immediately prior to application by the patient to form an easily applicable paste.
+Added: Our Spongilla technology is derived from a naturally grown freshwater sponge, Spongilla lacustris or Spongilla , which is processed into a powder that is mixed with a fluidizing agent immediately prior to application to form an easily applicable paste.
Spongilla is a unique freshwater sponge that only grows in commercial quantities in select regions of the world and under specific environmental conditions, all of which give it its distinctive anti-microbial, anti-inflammatory, and mechanical properties.
−Removed: The combination of these environmental conditions, the proprietary harvesting protocols developed with our supplier, and our post-harvest processing procedures produce a pharmaceutical product candidate that optimizes the mechanical component as well as the chemical components of the sponge for a product candidate with multiple mechanisms of action for the treatment of inflammatory skin conditions.
−Removed: Our lead product candidate DMT310, is intended to utilize our Spongilla technology for a once weekly treatment of a variety of skin diseases with our initial focus being for the treatment of acne vulgaris.
−Removed: However, due to the multiple mechanisms of action and anti-inflammatory effect seen with DMT310 throughout our various clinical trials for acne, we have quickly moved DMT310 into clinical trials for two additional indications, psoriasis and rosacea.
−Removed: We recently completed a Phase 1b proof of concept, or POC, trial in psoriasis and in November 2021 we initiated a Phase 2 clinical trial of DMT310 for the treatment of rosacea.
−Removed: Our second product candidate utilizing our Spongilla technology is our combination treatment, DMT410.
−Removed: DMT410 is intended to consist of one treatment of our proprietary sponge powder followed by one topical application of botulinum toxin for delivery into the dermis.
−Removed: We first tested this program in a Phase 1 POC trial of axillary hyperhidrosis patients which saw 80% of patients achieve a reduction in gravimetric sweat production greater than 50% four weeks after treatment.
−Removed: Based on DMT410’s ability to effectively deliver botulinum toxin to the dermis, we initiated a Phase 1 POC trial of DMT410 for the treatment of multiple aesthetic skin conditions.
−Removed: On November 19, 2021, we announced top-line results from this trial where we saw encouraging data that we believe warrants further investigation of this program.
−Removed: We believe our Spongilla technology platform will enable us to develop and formulate singular and combination products that are able to target topical delivery of chemical compounds into the dermis for a variety of indications.
−Removed: We believe the mechanical ability of the Spongilla technology allows for the intradermal delivery of a variety of large and small molecules to a targeted treatment site, through topical application as seen in our Phase 1a DMT410 hyperhidrosis trial.
−Removed: We believe the combination of Spongilla’s mechanical and chemical components (which we believe have demonstrated, in-vitro, anti-microbial and anti-inflammatory properties), add to the versatility of our Spongilla technology platform, allowing for application in the treatment of a wide variety of medical and aesthetic skin conditions and diseases.
−Removed: DMT310 is intended to consist of two grams of powder processed from a naturally grown freshwater sponge, Spongilla lacustris , which powder is then mixed with a fluidizing agent (hydrogen peroxide) immediately prior to application by the patient to form an easily applicable paste, like a mud mask.
−Removed: The paste is left on the skin for approximately fifteen minutes until dry, after which time it is washed off with water.
−Removed: Due to the unique combination of DMT310’s mechanical components and chemical components, we believe patients will only need to apply the product once weekly to produce a treatment effect.
−Removed: The mechanical components of the Spongilla powder consist of many microscopic siliceous spicules that, when massaged into the skin, penetrate the stratum corneum (the skin’s outermost protective layer) and create microchannels into the dermis where many facets of inflammatory skin diseases reside.
−Removed: We believe that the penetration of the spicules cause opening of microchannels which allow oxygen to enter pilosebaceoius glands, helping to kill C.
−Removed: acnes , which grow in an anaerobic environment ( C.
+Added: The combination of these environmental conditions, the proprietary harvesting protocols developed with our exclusive supplier, and our post-harvest processing procedures produce a pharmaceutical product candidate that optimizes the mechanical components as well as the chemical components of the sponge to create a product candidate with multiple mechanisms of action for the treatment of inflammatory skin conditions and aesthetic applications.
+Added: We believe our Spongilla technology platform will enable us to develop and formulate singular and combination products that are able to target the topical delivery of chemical compounds into the dermis for a variety of dermatology indications.
+Added: We believe the combination of Spongilla’s mechanical and chemical components (which we believe have demonstrated, in-vitro , anti-microbial and anti-inflammatory properties), add to the versatility of our Spongilla technology platform’s effectiveness as a singular product, in the treatment of a wide variety of medical skin diseases like acne and psoriasis.
+Added: We also believe the mechanical properties of our Spongilla technology allows for the intradermal delivery of a variety of large molecules, like botulinum toxins, monoclonal antibodies, or dermal fillers, to target treatment sites, through topical application without the need for needles.
+Added: Our lead product candidate, DMT310, is intended to utilize our Spongilla technology for once weekly treatment of a variety of skin diseases, with our initial focus being the treatment of acne vulgaris, which has a U.S.
+Added: market size of approximately 50 million patients.
+Added: We have shown DMT310’s ability to treat the multiple causes of acne in a Phase 2b study where we initially saw a 45% reduction in inflammatory lesions after four treatments, with statistically significant improvements at all time points for all three primary endpoints throughout the study (reduction in inflammatory lesions, reduction in non-inflammatory lesions, and improvement in Investigator Global Assessment).
+Added: Based on this Phase 2b data we are currently preparing for an end of phase 2 meeting with the FDA to finalize requirements prior to initiating a phase 3 program in the second half of 2023.
+Added: In addition, based on the multiple mechanisms of action and anti-inflammatory effect seen with DMT310 acne trial, we completed a Phase 1b proof of concept, or POC, trial in psoriasis where we saw encouraging results warranting further investigation.
+Added: DMT310 consists of two grams of powder processed from the naturally grown freshwater sponge, Spongilla lacustris.
+Added: The patient mixes the powder with a fluidizing agent (hydrogen peroxide) immediately prior to application by the patient to form an easy-to-apply paste.
+Added: The paste is applied similar to a mud mask and is left on the skin for approximately ten to fifteen minutes, after which time it is washed off with water.
+Added: Due to the unique combination of DMT310’s mechanical components and chemical components, and based on our Phase 2 acne data, we believe patients will only need to apply DMT310 once-weekly to produce a desired treatment effect.
+Added: The mechanical components of the Spongilla powder consist of many microscopic siliceous, needle-like spicules that, when massaged into the skin, penetrate the stratum corneum (the skin’s outermost protective layer) and create microchannels into the dermis where pro-inflammatory cytokines and bacteria reside.
+Added: We believe that the penetration of the spicules also leads to the opening of microchannels, which allow oxygen to enter pilosebaceous glands, helping to kill C.
+Added: acnes , which grow in an anaerobic (without oxygen) environment ( C.
acnes is the bacteria that cause inflammatory lesions in acne patients).
−Removed: The spicules also cause turnover of the top layer of dead skin, increasing collagen production.
−Removed: The spicules may also provide a channel for DMT310’s naturally occurring chemical compounds to be delivered to the dermis and pilosebaceous glands, helping to kill the C.
+Added: The spicules also cause rejuvenation of the top layer of dead skin, thereby increasing collagen production.
+Added: Additionally, we believe the newly created microchannels provide a conduit for DMT310’s naturally occurring chemical compounds to be delivered to the dermis and pilosebaceous glands, helping to kill the C.
+Added: acnes and fight inflammation .
In addition to these anti-microbial compounds, DMT310 also appears to have anti-inflammatory chemical compounds, as demonstrated in in vitro experiments, that inhibit inflammation through the reduction of C.acnes stimulated IL-8 production and by inhibiting IL-17A and IL-17F expression in human cell lines.
−Removed: Also during in-vitro studies of DMT310’s organic compounds, we observed the inhibition of lipogenesis of sebocytes, which may translate to a reduction in sebum (an oily and waxy substance produced by the human body’s sebaceous glands) production and oiliness of the skin in patients, which has been noted by a number of clinical investigators in our previous acne studies.
−Removed: We believe the combination of these biological effects along with the mechanical effects of the spicules are important factors to treat multiple inflammatory skin diseases.
+Added: Also, during in vitro studies of DMT310’s organic compounds, we observed the inhibition of the lipogenesis of sebocytes, which may translate to a reduction in sebum (an oily and waxy substance produced by the human body’s sebaceous glands) production and the oiliness of the skin in patients, which was observed by a number of clinical investigators in our Phase 2 acne studies.
+Added: We believe the combination of these biological and mechanical effects could be important factors in treating multiple inflammatory skin diseases, as seen in our clinical trials.
+Added: Our second product candidate utilizing our Spongilla technology is DMT410, our combination treatment.
+Added: DMT410 is intended to consist of one treatment of our proprietary sponge powder followed by one topical application of botulinum toxin for delivery into the dermis.
+Added: Currently, botulinum toxin is only approved to be delivered to the dermis by intradermal injections, which can be painful for the patient and time-consuming for the physician.
+Added: However, we believe DMT410’s ability to topically deliver botulinum toxin into the dermis could have similar levels of efficacy to existing delivery techniques, with fewer tolerability issues, and a quicker application time, possibly replacing the need for intradermal injections.
+Added: We first tested DMT410 in a Phase 1 POC trial of axillary hyperhidrosis patients, which saw 80% of patients achieve a reduction in gravimetric sweat production greater than 50% four weeks after a single treatment.
+Added: With almost 40% of the hyperhidrosis market currently being treated with intradermal injections of botulinum toxin, we believe there could be significant opportunity for DMT410 to break into this market and replace intradermal injections of botulinum toxin.
+Added: Based on DMT410’s ability to effectively deliver botulinum toxin to the dermis as observed in the Phase 1 axillary hyperhidrosis trial, we also conducted a Phase 1 POC trial of DMT410 for the treatment of multiple aesthetic skin conditions, including reduction of pore size, sebum production, and fine lines, among others.
+Added: In November 2021, we announced top-line results from this trial, where we saw promising data that we believe warrants further investigation of DMT410.
+Added: We are currently in the process of discussing partnering opportunities with botulinum toxin companies to move the DMT410 program into Phase 2 studies.
Application of DMT310
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after 10-15 minutes the product is easily removed with water.
−Removed: DMT410 is the second product candidate from our Spongilla platform.
−Removed: We are developing DMT410 for the topical treatment of skin diseases and conditions typically treated with multiple intradermal injections of botulinum toxin.
−Removed: DMT410’s combination treatment regimen uses one application of our unique Spongilla powder followed by one topical application of botulinum toxin to enable the topical delivery of botulinum toxin into the dermis for the treatment of a variety of indications, including for the treatment of hyperhidrosis and multiple aesthetic skin conditions, including improvement in overall skin quality, reducing pore size and count, reducing sebum production, reducing fine lines and increasing brightness and luminosity.
−Removed: If approved by the FDA, we believe DMT410’s topical delivery of botulinum toxin can greatly increase its market opportunities due DMT410’s needle-free application, targeted intradermal delivery and potential for expanded indications.
−Removed: We believe that the current medical and aesthetic dermatology landscape lacks innovative treatment options, mainly seeing the introduction of reformulations and combinations of old molecules.
−Removed: This provides an ideal opportunity to change how patients treat their skin conditions.
−Removed: With our anticipated once weekly treatment schedule, we believe we can become a leader in the space with a product candidate derived from a natural sponge that may improve patient compliance with minimal side effects and a rapid time to treatment effect, as seen in our multiple clinical trials in acne and psoriasis.
+Added: We believe that the current medical and aesthetic dermatology landscape lacks innovative treatment options, mainly seeing the introduction of reformulations or combinations of old molecules.
+Added: We believe this lack of innovation provides an ideal opportunity for us to change how patients treat their skin conditions.
+Added: With our anticipated once weekly treatment schedule and product candidate derived from a natural source, we believe we can become a leader in the space that may improve patient compliance with minimal side effects and a rapid time to treatment effect, as seen in our multiple clinical trials in acne, psoriasis, hyperhidrosis and aesthetic conditions.
If we can successfully develop our product candidates, receive FDA approval, develop a concentrated prescribing base of dermatologists, and utilize our management’s prior experience, we believe we have the ability to build a commercial organization to develop and commercialize treatment options in our core areas of focus within the dermatology space.
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In June 2020, we completed a randomized, double-blind, multicenter, placebo-controlled Phase 2b clinical trial of DMT310 for the once weekly treatment of moderate-to-severe acne.
−Removed: DMT310 showed statistically significant improvement versus placebo for all three endpoints (inflammatory lesion counts, non-inflammatory lesion counts, and the Investigators Global Assessment), after only four topical treatments and continued until the end of study at week 12.
−Removed: We plan on using these same endpoints in our two upcoming Phase 3 trials to support the filing of our NDA for DMT310 for the treatment of moderate-to-severe acne vulgaris.
−Removed: We believe these results from once weekly applications may favorably position DMT310 in the market for the treatment of moderate-to-severe acne.
−Removed: We intend to initiate the two required Phase 3 clinical trials in 2023 after holding our End of Phase 2 meeting with the FDA in the first half of 2023.
+Added: DMT310 showed statistically significant improvement versus placebo for all three endpoints (inflammatory lesion counts, non-inflammatory lesion counts, and the Investigators Global Assessment), after only four topical treatments and continued to statistically separate from placebo until the end of study at week 12.
+Added: We plan on using these same endpoints in our Phase 3 program of DMT310 for the treatment of moderate-to-severe acne to support the filing of our NDA for DMT310 for the treatment of moderate-to-severe acne vulgaris.
+Added: We believe these results from once weekly applications may favorably position DMT310 as a first-in-class product in the market for the treatment of moderate-to-severe acne.
+Added: We intend to initiate the Phase 3 program in 2023 after holding our end of phase 2 meeting with the FDA in the first half of 2023.
Mild-to-Moderate Psoriasis.
In October 2021, we completed a Phase 1b POC trial of DMT310 for the once weekly treatment of mild-to-moderate psoriasis.
−Removed: Plaque psoriasis is a chronic, inflammatory skin disease that comprises approximately 80% of the psoriasis market as of 2019, according to Fortune Business Insights Market Research Report, with a majority of patients having mild-to-moderate disease which makes them less likely to receive an approved biologic treatment, that are only indicated for patients with moderate to severe disease, as a first line therapy.
+Added: Plaque psoriasis is a chronic, inflammatory skin disease that comprises approximately 80% of the psoriasis market as of 2019, according to Fortune Business Insights Market Research Report, a majority of patients have mild-to-moderate disease which makes them less likely to receive an approved biologic treatment, that are only indicated for patients with moderate to severe disease, as a first line therapy.
Due to the large population of patients who suffer from mild-to-moderate psoriasis, and lack of effective topical therapies for more mild disease, we believe there is a large unmet need for an effective topical product with limited side effects.
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Patients were treated with DMT310 once a week for 12 weeks.
−Removed: Based on the efficacy, safety and tolerability profile observed in the POC trial, we initiated additional work to better inform our clinical trial design prior to moving into a larger Phase 2, placebo-controlled, clinical trial, which we anticipate initiating in 2022.
−Removed: Assuming this trial is successful, we plan on requesting an End of Phase 2 meeting with the FDA in 2023, followed by Phase 3 psoriasis studies in the first half of 2024.
+Added: Based on the efficacy, safety and tolerability profile observed in the POC trial, we initiated additional work to better inform our clinical trial design prior to moving into a larger Phase 2, placebo-controlled, clinical trial
Moderate-to-Severe Rosacea.
−Removed: We enrolled our first patient in a Phase 2 clinical trial of DMT310 for the once weekly treatment of moderate-to-severe rosacea in November 2021.
−Removed: Papulopustular Rosacea, or subtype II, is a chronic skin disease characterized by inflammatory lesions on the face that typically affects adults of all ages, but particularly affects women aged 30-50 and can cause great emotional and psychological distress.
−Removed: Due to the lack of effective therapies currently on the market, we believe there is a significant need for an effective topical product with limited side effects.
−Removed: Based on the effect against inflammatory lesions observed in the Phase 2b acne trial, along with multiple biomarkers seen in-vitro, we believe DMT310 may have similar anti-inflammatory effects in rosacea as seen in acne due to it also being a disease of inflammatory lesions on the face and may be a potential treatment option for patients suffering from this disease.
−Removed: We plan to enroll 180 patients, 18 years of age or older, with moderate-to-severe rosacea and provide them with once weekly treatments of DMT310 for 12 weeks and plan to report top-line results from this trial in the second half of 2022.
−Removed: The clinical endpoints for this trial are intended to be the absolute reduction in inflammatory lesion count, and an Investigator’s Global Assessment score on a scale of 0 to 4.
−Removed: There can be no assurance that DMT310 will receive FDA approval for any of the foregoing indications.
+Added: On December 5, 2022, we announced topline results from our Phase 2 trial of once-weekly topical application of DMT310 for the treatment of moderate-to-severe rosacea.
+Added: The data was supportive of DMT310 as a treatment for inflammatory skin diseases, but the rosacea study did not meet its primary endpoints.
+Added: While some patients did achieve a meaningful change in their rosacea, with 36% of DMT310 patients meeting the criteria for a responder on the Investigator Global Assessment (IGA) score, DMT310 was not able to statistically separate from placebo with 23% of placebo patients meeting the criteria as a responder at Week 12.
+Added: A treatment responder is defined as an IGA grade of ‘clear’ or ‘almost clear’ and at least a 2-grade improvement from baseline.
+Added: Based on the foregoing, we have decided not to devote any further financial resources to development of this indication for DMT310, and we have determined not to pursue further development efforts regarding this indication for DMT310.
We are developing the second product candidate from our Spongilla platform, DMT410, for the topical treatment of skin diseases and aesthetic conditions typically treated with multiple injections of botulinum toxin.
Currently, botulinum toxin must be injected multiple times to successfully deliver enough botulinum toxin to the desired treatment area.
−Removed: While injections are effective for many different diseases and aesthetic conditions, they limit botulinum toxin’s use for additional conditions where injections are difficult, painful, or otherwise not viable.
+Added: While injections are effective for many different diseases and aesthetic conditions, they limit botulinum toxin’s use for additional conditions where injections, especially intradermal injections, are difficult, painful, or otherwise not viable.
DMT410’s combination treatment regimen uses one application of our unique Spongilla powder followed by one topical application of botulinum toxin.
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The botulinum toxin is then massaged into the treatment area to take advantage of the microchannels created by Spongilla’s spicules, which allows the botulinum toxin to penetrate the stratum corneum and enter the dermis.
−Removed: We believe this treatment application will enable the topical delivery of botulinum toxin into the dermis for the treatment of a variety of medical diseases, including for the treatment of hyperhidrosis, acne, and rosacea, as well as improving skin, luminosity, brightness, and reducing pore size and count, and fine lines.
−Removed: We believe DMT410’s topical delivery of botulinum toxin can greatly increase market opportunities for botulinum toxin due DMT410’s needle-free application, targeted intradermal delivery and potential for expanded indications that do not require injections.
−Removed: To date, we have completed an open-label Phase 1b POC clinical trials of DMT410 for the treatment of axillary hyperhidrosis and an open-label Phase 1b POC clinical trial in multiple aesthetic skin conditions.
−Removed: The Phase 1b POC trial for axillary hyperhidrosis consisted of 10 patients receiving one treatment of DMT410 on each axilla.
−Removed: Four weeks after one treatment with DMT410, patients exhibited reduction in sweat production.
+Added: We believe this treatment application will enable the topical delivery of botulinum toxin into the dermis for the treatment of a variety of medical diseases, including for the treatment of hyperhidrosis, acne, and acne scars, as well as improving the skin’s luminosity, brightness, and reducing pore size and count, fine lines, and sebum production.
+Added: We believe DMT410’s topical delivery of botulinum toxin can greatly increase market opportunities for botulinum toxin due DMT410’s needle-free application, targeted intradermal delivery, thus potentially expanding the aesthetic market for botulinum toxin.
+Added: To date, we have completed an open-label Phase 1b POC clinical trial of DMT410 for the treatment of axillary hyperhidrosis and an open-label Phase 1b POC clinical trial in multiple aesthetic skin conditions.
+Added: The Phase 1b POC trial for axillary hyperhidrosis consisted of 10 patients receiving one treatment of DMT410 to each axilla.
+Added: Four weeks after one treatment with DMT410, patients exhibited a reduction in sweat production.
The clinical endpoints for this trial included (i) percent of patients with greater than 50% reduction in gravimetrically measured sweat production from baseline, (ii) percent of patients with gravimetric sweat production less than 50mg, and (iii) percent change in gravimetric sweat production.
−Removed: Four weeks after one treatment with DMT410, 80% of patients experienced a decrease in gravimetric sweat production greater than 50%, 85% of patients experienced gravimetric sweat production of less than 50mg, and patients had an average decrease in gravimetric sweat production of 75% from baseline.
−Removed: We believe these results support that DMT410 may aid in the topical delivery of botulinum toxin into the dermis for a treatment effect similar to multiple injections of botulinum toxin.
+Added: Four weeks after one treatment with DMT410, 80% of patients experienced a decrease in gravimetric sweat production greater than 50%, 85% of patients recorded gravimetric sweat production of less than 50mg, and patients had an average decrease in gravimetric sweat production of 75% from baseline.
+Added: We believe these results support that DMT410 may aid in the topical delivery of botulinum toxin into the dermis for a treatment effect similar to multiple intradermal injections of botulinum toxin.
With DMT410, we believe botulinum toxin may be applied topically to penetrate the skin into the dermis without the need for multiple injections.
−Removed: We recently completed an open-label, ten (10) patient, Phase 1b POC trial of DMT410 for the treatment of multiple aesthetic skin conditions ( pore size, Global Aesthetic Improvement, brightness, luminosity, sebum production, fine lines under the eye, glabellar lines, forehead lines, and lateral canthal lines.
+Added: We also completed an open-label, ten (10) patient, Phase 1b POC trial of DMT410 for the treatment of multiple aesthetic skin conditions (pore size, Global Aesthetic Improvement, brightness, luminosity, sebum production, fine lines under the eye, glabellar lines, forehead lines, and lateral canthal lines).
In our Phase 1b POC trial of DMT410, patients received one treatment of DMT410 and were evaluated every four weeks for a total duration of 16 weeks to determine DMT410’s safety and tolerability profile, effectiveness, and its duration of treatment effect.
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These physicians graded results were supported by objective analysis provided by Canfield Scientific’s VISIA and PRIMOS visual analysis camera systems.
−Removed: Based on these results, we are actively seeking a partner with a botulinum toxin to continue development of DMT410 in a larger placebo-controlled Phase 2 trial where we can study multiple doses of botulinum toxin applied to the entire face.
−Removed: We believe these results, combined with our results in hyperhidrosis, further demonstrate how DMT410’s combination regimen could greatly expand the potential indications for botulinum toxins for aesthetic skin conditions, as well as other dermatologic skin diseases such as hyperhidrosis, acne, or rosacea.
+Added: Based on these results, we are actively seeking to partner with a botulinum toxin to continue development of DMT410 in a larger placebo-controlled Phase 2 trial where we can study multiple doses of botulinum toxin applied to the entire face.
+Added: We believe these results, combined with our results in hyperhidrosis, clearly demonstrate how DMT410’s combination regimen could greatly expand the potential indications for botulinum toxins for aesthetic skin conditions, as well as other dermatologic skin diseases such as hyperhidrosis, acne, or acne scars.
There can be no assurance that DMT410 will receive FDA approval for any of the foregoing indications.
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Complete development and regulatory approval of DMT310 for acne .
−Removed: We recently completed a Phase 2b clinical trial of DMT310 for the treatment of moderate-to-severe acne.
−Removed: We plan to hold an End of Phase 2 meeting with the FDA in the first half of 2023 and initiate two pivotal Phase 3 clinical trials for DMT310 approximately 3-4 months after receiving feedback from the FDA at the EOP2 meeting.
−Removed: The Phase 3 trials will take approximately 15 months to complete.
−Removed: Assuming positive results from these two Phase 3 trials, we plan on submitting an New Drug Application approximately 6 months after completion of the trials.
−Removed: Complete a Phase 2 trial of DMT310 for the treatment of psoriasis.
−Removed: In October 2021, we announced top-line results of our Phase 1b POC trial in patients with mild-to-moderate psoriasis.
−Removed: We believe the results of this POC study warrant the continued development of DMT310 for the treatment of psoriasis.
−Removed: We plan to initiate a Phase 2 trial for DMT310 in psoriasis in 2022.
−Removed: If successfully developed and commercialized, we believe DMT310 would be the first once weekly topical product available to treat psoriasis.
−Removed: Complete a Phase 2 trial of DMT310 in rosacea .
−Removed: Based on the data obtained from our Phase 2 trials in acne and the anti-inflammatory results seen in-vitro, we initiated a Phase 2 trial of DMT310 for the treatment of rosacea in November 2021, with top-line results expected in 2022.
−Removed: We believe this will help bolster our pipeline and could establish the broader use of DMT310 in multiple inflammatory skin diseases.
+Added: We completed a Phase 2b clinical trial of DMT310 for the treatment of moderate-to-severe acne.
+Added: We plan to hold an End of Phase 2 meeting with the FDA in the first half of 2023 and initiate a Phase 3 program for DMT310 in the second half of 2023.
+Added: Assuming positive results from these two Phase 3 trials, we plan on submitting a New Drug Application approximately 6 months after completion of the trials.
Explore mutually beneficial partnership opportunities for our DMT410 program in hyperhidrosis and aesthetic skin conditions.
In November 2021, we announced top-line results of our Phase 1b POC trial of DMT410 for the treatment of multiple aesthetic skin conditions using our Spongilla technology for the topical application of OnabotulinumtoxinA (brand name BOTOX®).
−Removed: We believe this trial provides further evidance of the ability for DMT410 to topically deliver botulinum toxin into the dermis for skin conditions and diseases.
+Added: We believe this trial provides further evidence of the ability for DMT410 to topically deliver botulinum toxin into the dermis for skin conditions and diseases.
Based on the results of DMT410 in hyperhidrosis and aesthetics, we are currently exploring partnership opportunities to further develop DMT410 for the topical treatment of skin diseases and aesthetic skin conditions.
+Added: Complete a Phase 2 trial of DMT310 for the treatment of psoriasis.
+Added: In October 2021, we announced top-line results of our Phase 1b POC trial in patients with mild-to-moderate psoriasis.
+Added: We believe the results of this POC study warrant further development of DMT310 for the treatment of psoriasis.
+Added: If successfully developed and commercialized, we believe DMT310 would be the first once weekly topical product available to treat psoriasis.
+Added: The DMT310 program for psoriasis is currently on hold with further advancement subject to obtaining additional financing and/or a strategic partner.
Acquire or in-license additional dermatology programs to our portfolio that complement our current product candidates .
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Dermatology Market Overview
−Removed: We are currently focused on the medical and aesthetics dermatology markets, which include multiple common and undertreated skin diseases and conditions such as acne, rosacea, psoriasis, hyperhidrosis, and multiple aesthetic conditions, some with no currently approved products, including the reduction of fine lines, pore size, sebum production and improvement in luminosity and overall skin quality.
+Added: We are currently focused on the medical and aesthetics dermatology markets, which include multiple common and undertreated skin diseases and conditions such as acne, psoriasis, hyperhidrosis, and multiple aesthetic conditions, some with no currently approved products, including the reduction of fine lines, pore size, sebum production and improvement in luminosity and overall skin quality.
We believe these diseases and conditions cause significant negative impacts on patients’ quality of life, including physical and emotional trauma and social stigmatism, causing patients to constantly seek better treatment options to help alleviate their conditions.
−Removed: We also believe these markets have not experienced the same level of development and advances as other markets, as there have been few novel or innovative topical products recently approved other than reformulations or combinations of existing compounds.
+Added: We also believe these markets have not experienced the same level of development and advances as other markets, as there have been few innovative topical products recently approved other than reformulations or combinations of existing compounds.
We believe our product candidates will be well situated within the market and offer the innovative solutions to the underserved medical and aesthetic dermatology markets.
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There are many factors that continue to drive growth in the aesthetics dermatology market such as greater patient acceptance, including from an increase in younger patients, and the discretionary cash that patients are willing to spend on aesthetic care.
−Removed: We also believe patients have a growing willingness to pay out-of-pocket for effective skin treatments in achieve their desired personal aesthetic look, which further supports the demand and pricing in those markets.
−Removed: Based on the foregoing, we believe the dermatology market, both aesthetics and medical, offers a low-cost commercialization opportunity compared to many other prescription based specialty markets, due to the relatively small number of specialists in the dermatology field.
−Removed: According to the American Academy of Dermatology, in 2020 there were approximately 18,000 dermatologists in the U.S.
−Removed: We plan to target a subset of these dermatologists, who are larger prescribers of competitive products and who treat a large percentage of patients with our approved indications by creating a targeted sales force, to cover a significant portion of our target physicians.
−Removed: We believe the combination of a prescription based and cash-pay based product lines is an attractive business opportunity, as it incorporates multiple aspects of the dermatology market that move independent of the greater healthcare market.
+Added: We also believe patients have a growing willingness to pay out-of-pocket for effective skin treatments to achieve their desired personal aesthetic look, which further supports the demand and pricing in those markets.
+Added: Based on the foregoing, we believe the dermatology market, both aesthetic and medical, offer a low-cost commercialization opportunity compared to many other prescription-based specialty markets, due to the relatively small number of specialists in the dermatology field.
+Added: According to the American Academy of Dermatology, in 2020 there were approximately 18,000 dermatologists in the U.S., and we plan to target a subset of these dermatologists, who are larger prescribers of competitive products and who treat a large percentage of patients with our approved indications.
+Added: We believe the combination of prescription based and cash-pay based product lines is an attractive business opportunity, as it incorporates multiple aspects of the dermatology market that move independent of the greater healthcare market.
Background of Our Spongilla Technology
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Spongilla’s Multiple Mechanism of Actions
−Removed: The unique properties of Spongilla lacustris not only allows us to reference the FDA’s Botanical Guidance, but also helps ensure the regrowth of sufficient supply of raw material each year.
+Added: The unique properties of Spongilla lacustris not only allows us to reference the FDA’s Botanical Guidance, but also helps ensure the sustainable regrowth of sufficient supply of raw material each year.
While Spongilla is technically a part of the animal kingdom, it grows and acts more similarly to a plant in that it can completely regenerate every year, even in harsh environmental conditions.
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These spicules are smooth, rod-like shapes which come to a point on each end, and if the Spongilla is harvested under certain proprietary environmental conditions, the spicules can average between 150-300 micrometers in length and about 10-15 micrometers in diameter.
−Removed: While there are other types of freshwater and marine sponges, many of their spicules can be covered in barbs or hooks which we believe would get stuck in the skin or are blunt on each end, making skin penetration difficult.
+Added: While there are other types of freshwater and marine sponges, many of their spicules can be covered in barbs or hooks which we believe would get stuck in the skin or contain spicules that are blunt on each end, making skin penetration difficult.
Siliceous Spicules Present in Spongilla
−Removed: After harvesting and further processing in the U.S., the shape and size of our spicules make them the ideal mechanism to penetrate the stratum corneum, the skins barrier, and temporarily create a micro-channel into the dermis without penetrating into subcutaneous tissue, where the larger blood vessels are located.
+Added: After harvesting and further processing in the U.S., the form and size of our spicules make them the ideal mechanism to penetrate the stratum corneum, the skins barrier, and temporarily create a micro-channel into the dermis without penetrating into subcutaneous tissue, where the larger blood vessels are located.
These newly created microchannels temporarily open the skin’s barrier to allow for the targeted delivery of large and small chemical compounds into the dermis.
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It is derived from freshwater Spongilla lacustris , or Spongilla , which grows under certain environmental conditions in select locations throughout the northern hemisphere .
−Removed: Our Spongilla raw material is harvested by our exclusive partner in Russia abiding by strict protocols which our supplier has developed over 18 years.
+Added: Our Spongilla raw material is harvested by our exclusive partner in Russia abiding by strict protocols based on our suppliers 20 years of experience and our expertise in an ideal pharmaceutical product.
The result of these strict protocols is a consistent chemical structure that is reproducible year after year, which is critical in producing a material able to be used in a pharmaceutical product.
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DMT310 utilizes the Spongilla’s mechanical spicules to help resurface a patient’s skin while also creating microchannels through the stratum corneum to allow the penetration of the Spongilla’s naturally created organic compounds to help treat various skin diseases.
−Removed: We believe these organic compounds can travel through the newly created microchannels into the dermis and sebaceous gland where both inflammatory and non-inflammatory acne lesions originate.
+Added: We believe these organic compounds can travel through the newly created microchannels into the dermis and sebaceous glands where both inflammatory and non-inflammatory acne lesions originate.
DMT310 targets treatment of the multiple facets of acne by combining the substantial mechanical and chemical activity of Spongilla into an easy to apply product that only needs to be applied once weekly.
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It affects approximately 50 million people in the U.S., with about 85% of teenagers experiencing some form of acne.
−Removed: prescription acne market had approximately $2.3 billion in prescription pharmaceutical sales in 2019, according to IQVIA Inc.
+Added: prescription acne market had approximately $2.6 billion in prescription pharmaceutical sales in 2016 and is expected to reach approximately $3.8 billion in 2026 according to GlobalData Inc.
Most patients experience some form of acne during their teenage years and for some, their acne may diminish over time, or at least tends to decrease by age 25.
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Therefore, we believe early and aggressive treatment with an effective once weekly product may lessen the overall long-term impact of this disease and may lead to an increase in a patient’s quality of life.
−Removed: Due to acne’s negative impact on a patient’s quality of life and negative impact on facial aesthetic, patients suffering from acne tend to be highly motivated to treat their acne and we believe more willing to pay more out-of-pocket for higher priced and highly effective treatments.
+Added: Due to acne’s negative impact on a patient’s quality of life and negative impact on facial aesthetic, patients suffering from acne tend to be highly motivated to treat their acne and we believe willing to pay more out-of-pocket for higher priced and highly effective treatments.
It is our belief that patients seeking an easy to use and effective topical product will tolerate less favorable reimbursement rates than for other prescription products for other indications, allowing for favorable pricing if we are able to eventually obtain approval for and successfully commercialize DMT310 for acne.
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typically treated with a combination of oral and topical prescription therapies.
−Removed: Severe Acne :
characterized by substantial papules and pustules, with many nodules and/or cysts and significant inflammation;
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Limitations of Current Standard of Care .
−Removed: While current treatment options may be effective for some patients, there are many limitations and drawbacks of current acne products which cause poor patient adherence.
−Removed: All currently approved topical therapies for the treatment of acne must be applied once or twice a day to allow an accumulation of product within the skin to effectively treat the disease.
+Added: While current treatment options may be effective for some patients, there are many limitations and drawbacks of current acne products which cause poor patient compliance.
+Added: All currently approved topical therapies for the treatment of acne must be applied once or twice a day to allow an accumulation of the active ingredient within the skin to effectively treat the disease.
This requirement to apply multiple times per day becomes very onerous and time consuming for patients, causing many patients to fail to comply with the strict application regimen and/or skip multiple treatments.
−Removed: Proper use and application schedules are particularly important for topical acne products and poor patient adherence may lead to reduced treatment effect and ultimately discontinuation of treatment due to lack of effect.
−Removed: Many current acne products, such as retinoids, must be applied at least once-a-day and may cause significant stinging, burning, and peeling after each application.
−Removed: These tolerability issues, which may start occurring after the first application, and the substantial discomfort they cause, lead many patients to discontinue the necessary daily application schedule.
+Added: Proper use and application schedules are particularly important for topical acne products and poor patient adherence may lead to reduced treatment effect and ultimately discontinuation of treatment by the patient due to the lack of effect.
+Added: Many current acne products, such as retinoids that must be applied at least once-a-day, may cause significant stinging, burning, and peeling after each application.
+Added: These tolerability issues, which may start occurring after the first application, and the substantial discomfort they cause, lead many patients to discontinue the necessary daily application schedule or the use of the product altogether.
It is well known that benzoyl peroxide, or BPO, leads to drying of the skin and that retinoids result in many local skin reactions including erythema, burning, and peeling, after the first treatment.
It has been observed in the combination study of adapalene/BPO, where more than 20% of the subjects reported moderate or severe erythema and stinging/burning.
−Removed: Lastly, most topical products have an unavoidable latency period of 6-8 weeks until patients have a definite improvement.
+Added: Lastly, most topical products have an unavoidable latency period of 6-8 weeks until patients have a definite improvement in their acne lesions.
This means they may have to endure 30 to 60 applications before observing that their acne is improving (assuming a daily, or twice daily regimen), all while dealing with the burning, stinging, and peeling that may accompany these topical products.
We believe that teenagers, who make up the largest segment of the acne market, become impatient with the lack of rapid perceived effect leading to premature discontinuation of treatment.
−Removed: The lack of rapid treatment effect, side effects, and onerous application schedules all greatly contribute to patient compliance issues and could ultimately lead to treatment failure.
−Removed: We believe patients are more concerned with efficacy outcomes than costs, thus we believe patients will be more willing to pay higher out of pocket costs.
+Added: The lack of rapid treatment effect, side effects, and onerous application schedules all greatly contribute to patient compliance issues and could ultimately lead to treatment failure for current topical therapies.
+Added: We believe patients are more concerned with rapid efficacy outcomes and low side effects than costs, thus we believe patients will be more willing to pay higher out of pocket costs for a product that has these attributes.
Our Solution for Moderate-to-Severe Acne.
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DMT310 is designed to be applied only once a week, rather than once or twice a day.
−Removed: We believe a once weekly schedule may be conducive to high patient compliance.
−Removed: In addition, in our recent Phase 2b acne trial, on average, patients experienced an approximately 45% reduction in inflammatory acne lesions after just four treatments, with continued improvement of up to 62% reduction at 12 weeks.
+Added: We believe a once weekly schedule may be conducive to high patient compliance as it is less onerous for the patient.
+Added: In addition, in our Phase 2b acne trial, on average, patients experienced an approximately 45% reduction in inflammatory acne lesions after just four treatments, with continued improvement of up to 62% reduction of inflammatory lesions at 12 weeks.
Further, approximately 90% of patients had no, or mild, tolerability issues at the end of the 12-week trial and no patients experienced any severe tolerability issues.
−Removed: In addition, in our Phase 2b trial we observed that DMT310 started showing a statistically significant difference from placebo after just four treatments while also having a rapid reduction on inflammatory and non-inflammatory lesions.
−Removed: We believe this rapid visible response encouraged patients to continue to adhere to the once weekly application schedule leading to a continued reduction in their lesions until the end of trial at week 12.
−Removed: Thus, we believe that a topical product that needs to be applied only once weekly with a quicker time to perceived treatment effect and fewer tolerability issues has the opportunity to exhibit greater treatment success due to improved patient adherence leading to loyal and repeat users.
+Added: In addition, in our Phase 2b trial we observed that DMT310 started showing a statistically significant difference from placebo for all three endpoints after just four treatments while also having a rapid reduction on inflammatory and non-inflammatory lesions.
+Added: We believe this rapid visible response encouraged patients to continue to comply with the once weekly application schedule leading to a continued reduction in their lesions until the end of trial at week 12.
+Added: Thus, we believe that a topical product that only needs to be applied once weekly with a quicker time to perceived treatment effect and fewer tolerability issues has the opportunity to exhibit greater treatment success due to improved patient compliance leading to loyal and repeat users.
DMT310 for the Treatment of Mild-to-Moderate Psoriasis
−Removed: We believe that DMT310 could also be an effective treatment for mild-to-moderate psoriasis based on the data received from our recently completed Phase 1b POC trial and the in-vitro effect seen on the down regulation of IL-17A and IL-17F, as well as its ease of application to mild-to-moderate psoriatic lesions with smaller surface areas.
+Added: We believe that DMT310 could also be an effective treatment for mild-to-moderate psoriasis based on the clinical data received from our recently completed Phase 1b POC trial and the in-vitro effect DMT310 has shown on the down regulation of IL-17A and IL-17F, as well as its ease of application to mild-to-moderate psoriatic lesions with smaller surface areas.
Psoriasis is characterized by “plaques,” or raised red areas of skin covered with a silver or white layer of dead skin cells referred to as “scales.” Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and the plaques are often itchy and sometimes painful.
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Market Opportunity.
−Removed: Patients are either underdiagnosed, undertreated or left untreated.
−Removed: This leaves patients seeking new treatment options.
+Added: Currently patients with mild-to-moderate disease are either underdiagnosed, undertreated or untreated.
+Added: This leaves patients seeking new and effective treatment options.
Psoriasis is a chronic, inflammatory skin disorder estimated to affect up to 3.2% of the world’s population with global sales of $14.2 billion in 2020, which is projected to increase to $27.5 billion by 2030.
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The primary endpoints in this trial were the Physician’s Global Assessment, which is a 6-point scale measuring the physician’s assessment of psoriasis severity of the target lesion site, the Psoriasis Area Severity Index scale is also a 6-point scale measuring the psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of surface area involvement and the Pruritus Visual Analog Scale consists of the patient’s measurement of pruritus, or itch, in addition to normal tolerability and safety assessments.
−Removed: We announced top-line results in October 2021, and based on the efficacy, safety and tolerability profile seen in the POC trial we initiated additional work to better inform the clinical trial design prior to moving into a larger Phase 2, placebo-controlled, clinical trial, which is anticipated to begin in 2022.
+Added: We announced top-line results in October 2021, and based on the efficacy, safety and tolerability profile seen in the POC trial we initiated additional work to better inform the clinical trial design prior to moving into a larger Phase 2, placebo-controlled, clinical trial.
DMT310 for the Treatment of Moderate-to-Severe Rosacea
−Removed: Based on the positive clinical data we observed against inflammatory lesions in our Phase 2b acne trial and the many similarities between acne vulgaris and papulopustular rosacea, we are also developing our DMT310 product for the treatment of papulopustular rosacea, or rosacea.
−Removed: We believe the broad anti-inflammatory results seen by DMT310 in clinical trials for acne may also be seen in papulopustular rosacea patients, as it is also a disease of papules and pustules, which are inflammatory lesions on the face.
−Removed: We believe there currently remains a high unmet need in rosacea for a safe and effective treatment and we believe a once weekly, naturally derived topical product could be an ideal candidate to fill this void.
−Removed: Thus, in November 2021, we started enrolling moderate-to-severe rosacea patients in a Phase 2 trial of the once weekly treatment of DMT310.
−Removed: We expect to have top-line results in the second half of 2022.
−Removed: Market Opportunity .
−Removed: Rosacea is a chronic, inflammatory skin disorder characterized by repeated remissions and exacerbations of facial redness and inflammatory lesions that can be challenging to treat.
−Removed: The pathogenesis of rosacea is not completely understood, but factors such as microbial overgrowth, vascular abnormalities, and abnormally high levels of cathelicidin in the skin have been suggested to be involved.
−Removed: Rosacea is further divided into four subtypes:
−Removed: erythematotelangiectatic, papulopustular, rhinophymatous, and ocular, with many patients having a combination of the various subtypes.
−Removed: There are over 16 million patients diagnosed with one or more forms of rosacea in the U.S.
−Removed: and it typically affects women, although more severe forms tend to affect men due lack of treatment.
−Removed: Depending on the presenting symptoms and their severity, treatment ranges from oral antibiotics to topical preparations including brimonidine, oxymetazoline, azelaic acid and others, all with substandard efficacy and associated side effects including stinging and burning, pruritus, as well as dryness and erythema.
−Removed: These issues with current treatment options can often lead to discontinuation of treatment and a prolongation of symptoms and patients suffering.
−Removed: Even with such drawbacks to current therapies, current topical products most commonly used to treat rosacea generate approximately $374 million in aggregate annual revenues in the U.S.
−Removed: in 2019, while the oral drugs typically prescribed for more severe cases are oral antibiotics and generate about $305 million in aggregate annual revenues in the U.S.
−Removed: in 2019 according to IQVIA Inc.
−Removed: Current rosacea treatments have some of the same limitations and compliance issues as current acne products, like cumbersome applications regimens and unwanted side effects.
−Removed: We believe this creates a large opportunity in the market for products that are easy to apply, such as DMT310.
−Removed: Limitations of Current Standard of Care.
−Removed: Since rosacea is a complex chronic disease combination therapy is typically required.
−Removed: Current topical treatment options for rosacea must be applied once or twice a day, and rosacea can have a significant impact on a patient’s quality of life due both to the unwanted cosmetic appearance of the disease and intolerable and painful symptoms associated with the disease.
−Removed: Moreover, with a once or twice a day application schedule, patients may experience side effects (such as dryness, stinging, burning, irritation and pruritis) after each treatment, resulting in poor patient compliance.
−Removed: Like acne, compliance with a product’s application regimen is critical in the treatment success of rosacea, especially because rosacea tends to intensify in the presence of certain environmental triggers.
−Removed: If left untreated, the hypertrophied tissue may require surgery to reshape and debulk the excess tissue.
−Removed: Despite the negative impact of the disease, very few rosacea patients seek treatment.
−Removed: We believe this is due to the limited treatment options available for these patients.
−Removed: Therefore, we believe an easy to apply once weekly treatment with minimal side effects and good tolerability could help alleviate some of the drawbacks with the current standard of care.
−Removed: Our Solution for Moderate-to-Severe Rosacea .
−Removed: Like the needs of patients with acne, based on a recent survey of rosacea patients, many indicated a low level of satisfaction with current treatment options leading to intermittent use of current therapies.
−Removed: We believe that a once weekly product derived from a natural source that effectively treats the inflammation associated with papulopustular rosacea may be the ideal solution for patients suffering from this disease.
−Removed: The formation of rosacea lesions is thought to be driven by early recruitment of TH1 and TH17 lymphocytes which ultimately causes neutrophil infiltration and lesion formation.
−Removed: Once the T-cells arrive to area, T cell derived cytokines such as IL-17 may, together with UV radiation, activate keratinocytes to produce the chemokines CXCL1 and CXCL8 and these chemokine cause neutrophils to migrate to the area, leading to the formation of inflammatory lesions.
−Removed: TH17 cells preferentially express the chemokine receptor CCR6, and its specific ligand CCL20 is upregulated by UVB irradiation stimulation in keratinocytes.
−Removed: This stimulation of the immune response by UV radiation may explain why sunlight exposure and IL-17 may exacerbate the lesions of rosacea.
−Removed: In addition to the promotion of neutrophil infiltration, IL-17 also promotes angiogenesis via the induction of VEGF, producing erythema and subsequent telangiectasia.
−Removed: Based on in-vitro data, DMT310 has shown a dose dependent inhibition of IL-17A and IL-17F along with potent anti-inflammatory properties seen in our Phase 2b acne trial.
−Removed: We believe the combination of these features, coupled with a once weekly application schedule, could allow for DMT310 to be a leading treatment option for patients suffering with rosacea.
−Removed: We recently enrolled our first patients in a Phase 2 clinical trial of DMT310 for the treatment of moderate-to-severe rosacea in November 2021.
−Removed: This trial will enroll approximately 180 patients across the U.S., where patients will be treated once weekly with a topical application of either DMT310 or placebo.
−Removed: Patients will be followed for 12 weeks, and the primary endpoints will include Investigator’s Global Assessment and inflammatory lesion counts along with tolerability and safety assessments.
−Removed: Conditioned upon the receipt of positive data from this Phase 2 trial, which we expect in the second half of 2022, we plan to hold an End of Phase 2 meeting with the FDA in the second half of 2023 and then plan to initiate a Phase 3 program to prepare for an NDA submission.
−Removed: We expect to initiate the Phase 3 program in 2024.
−Removed: We will leverage the nonclinical studies completed for our acne program to help support the NDA submission for rosacea.
−Removed: There can be no assurance that DMT310 will receive FDA approval in rosacea.
+Added: On December 5, 2022, we announced topline results from our Phase 2 trial of once-weekly topical application of DMT310 for the treatment of moderate-to-severe rosacea.
+Added: The data was supportive of DMT310 as a treatment for inflammatory skin diseases, but the rosacea study did not meet its primary endpoints.
+Added: While some patients did achieve a meaningful change in their rosacea, with 36% of DMT310 patients meeting the criteria for a responder on the Investigator Global Assessment (IGA) score, DMT310 was not able to statistically separate from placebo with 23% of placebo patients meeting the criteria as a responder at Week 12.
+Added: A treatment responder is defined as an IGA grade of ‘clear’ or ‘almost clear’ and at least a 2-grade improvement from baseline.
+Added: We believe that the 23% dropout rate in the DMT310 group may have contributed to the outcome of this study.
+Added: After further assessment of the data, we believe DMT310 may not be tolerable for rosacea patients, who tend to have more sensitive skin.
+Added: Based on the foregoing, we have decided not to devote any further financial resources to development of this indication for DMT310, and we have determined not to pursue further development efforts regarding this indication for DM310.
+Added: We will continue to focus our resources on our DMT310 program for acne based on the statistically significant results seen in our Phase 2b study.
DMT400 for the Topical Delivery of Macromolecules
−Removed: DMT400 is our combination treatment regimen that utilizes the unique mechanical features of our Spongilla technology to facilitate the intradermal delivery of macromolecules, such as botulinum toxin, monoclonal antibodies or dermal fillers, by topical application rather than with injections.
+Added: DMT400 is our combination treatment regimen that utilizes the unique mechanical features of our Spongilla technology to facilitate the intradermal delivery of macromolecules, such as botulinum toxin, monoclonal antibodies, dermal fillers, or vaccines, by topical application rather than with injections.
These macromolecules are highly effective and approved for the treatment of multiple medical and aesthetic skin conditions and diseases, but currently are not approved in a topical form because the molecular structures are too large to penetrate the stratum corneum, the skin’s outermost defense barrier.
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DMT400 works by first topically applying our proprietary sponge powder to the treatment area wherein the mechanical spicules of the sponge penetrate the skin, thereby creating microchannels into the dermis.
−Removed: Unlike a derma roller or other microneedle technology, our unique spicules remain in the skin for one to two days allowing the microchannel to remain open rather than close, as they would after using a derma roller, during which time a macromolecule can be applied topically to the skin.
+Added: Unlike a derma roller or other microneedle technology, our unique spicules remain in the skin for one to two days allowing the microchannel to remain open rather than close up, as they would after using a derma roller.
+Added: With the microchannel open for a longer period a macromolecule can be applied topically to the skin and is thus able to penetrate into the dermis.
We believe this topical application of a macromolecule can be massaged into the newly created microchannels thereby facilitating the delivery of the macromolecule, through the microchannel and into the dermis, without the need for injections.
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DMT410 for the Treatment of Primary Axillary Hyperhidrosis
−Removed: We initially tested our DMT400 treatment with our DMT410 program, which consists of a topical application of our proprietary sponge powder followed by a topical application of botulinum toxin.
−Removed: DMT410 was initially tested in a Phase 1b POC trial of ten (10) patients with primary axillary hyperhidrosis to determine if our Spongilla sponge powder could successfully facilitate the intradermal delivery of botulinum toxin and potentially other macromolecules.
−Removed: Based on the results seen from this study we believe we were successful in delivering active botulinum toxin to the dermis for the treatment of hyperhidrosis.
+Added: We initially tested our DMT400 treatment with our DMT410 program, which consists of a topical application of our proprietary sponge powder followed by a topical application of botulinum toxin, a macromolecule.
+Added: DMT410 was initially tested in a Phase 1b POC trial of ten (10) patients with primary axillary hyperhidrosis to determine if our sponge powder could successfully facilitate the intradermal delivery of botulinum toxin and potentially other macromolecules.
+Added: Based on the results seen from this study we believe we were successful in delivering active botulinum toxin to the dermis for the treatment of primary axillary hyperhidrosis and potentially other skin conditions.
Market Opportunity .
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It is believed to affect an estimated 15 million people in the U.S.
+Added: prescription hyperhidrosis market had approximately $66 million in prescription pharmaceutical sales in 2020, and is expected to reach approximately $282 million in 2030, with almost 40% from injections of BOTOX, according to GlobalData Inc.
According to a 2016 update on the prevalence and severity of hyperhidrosis in the U.S., axillary (underarm) hyperhidrosis, is the most common form of the disorder.
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Lastly, topical aluminum chloride treatment has a transient duration of effect and requires frequent reapplication to maintain sweat control.
−Removed: More recently, topical anticholinergics have been investigated by companies such as Brickell Biotech, Inc.
+Added: More recently, topical anticholinergics have been investigated by companies such as Fresh Tracks, Inc.
and Journey Medical Corporation (formerly developed by Dermira, Inc.), but we believe they tend to have the same side effects as systemic anticholinergics which are used off-label.
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We believe this leaves a wide gap in the market for a product that combines the efficacy of botulinum toxin with the safety and tolerability profile of topical therapies.
−Removed: We believe DMT410, if successfully commercialized, could address this market opportunity.
+Added: We believe DMT410, if successfully commercialized, could address this underserved market opportunity.
Our Solution for Primary Axillary Hyperhidrosis.
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There can be no assurance that DMT410 will receive FDA approval for hyperhidrosis.
−Removed: DMT410 for the Treatment of Aesthetic Conditions In addition to the use of DMT410 in the treatment of hyperhidrosis and other medical dermatology conditions such as acne and rosacea, based on the data from our recent Phase 1b POC trial of DMT410 for the treatment of multiple aesthetic skin conditions such as pore size, sebum production, fine lines, luminosity, and brightness of the skin, we believe DMT410 has an opportunity to be used for the treatment of multiple aesthetic skin conditions.
+Added: DMT410 for the Treatment of Aesthetic Conditions In addition to the use of DMT410 in the treatment of hyperhidrosis and other medical dermatology conditions such as acne, based on the data from our recent Phase 1b POC trial of DMT410 for the treatment of multiple aesthetic skin conditions such as pore size, sebum production, fine lines, luminosity, and brightness of the skin, we believe DMT410 has an opportunity to be used for the treatment of multiple aesthetic skin conditions.
Botulinum toxin is known to treat a variety of aesthetic skin conditions, but to achieve these positive effects, the botulinum toxin needs to be delivered to the dermis rather than the muscle to have the desired effect.
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Specifically, patients with an IGA > 1 at the Day 29 or Day 57 visits continued with once weekly study drug applications, while patients with an IGA 1 at these same visits were instructed to subsequently apply their assigned study drug biweekly (see Image 8 below for a presentation of the study drug application frequency algorithm).
−Removed: Image 8 Application Frequency Algorithm by Study Visit
+Added: Application Frequency Algorithm by Study Visit
This Phase 2a trial showed statistically significant and clinically meaningful effects for its endpoint, absolute reduction in inflammatory lesions when comparing DMT310 + 3% H 2 O 2 and placebo + water (control) groups at both week 8 and week 12 or end of study.
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DMT310 next steps for acne
−Removed: We are currently preceding with the necessary non-clinical and pharmacokinetic studies and once complete we plan to schedule an End of Phase 2 meeting with the FDA in the first half of 2023 to discuss and finalize the protocol for the Phase 3 clinical trials in moderate-to-severe acne.
+Added: We are currently preceding with the necessary non-clinical and pharmacokinetic studies and once complete we plan to schedule an End of Phase 2 meeting with the FDA in the first half of 2023 to discuss and finalize the protocol for the Phase 3 program in moderate-to-severe acne.
Once we are able to hold an End of Phase 2 meeting with the FDA and we receive approval to proceed with Phase 3, we plan to initiate a pivotal Phase 3 program for DMT310 for the treatment of moderate-to-severe acne.
We expect this Phase 3 program to include two, multi-center, placebo-controlled trials with identical clinical endpoints to our recently successful Phase 2b clinical trial of DMT310 for the treatment of moderate-to-severe acne.
−Removed: We expect to report top-line data from this program in 2024 and, assuming positive results, file a new drug application, or NDA, with the FDA shortly thereafter.
+Added: Once we receive top-line results from both Phase 3 studies, assuming positive results, we plan to file a new drug application, or NDA, with the FDA shortly thereafter.
This Phase 3 program is intended to be designed to demonstrate the safety and efficacy of the treatment of DMT310 relative to placebo for the treatment of moderate-to-severe acne.
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DMT310 Phase 1a Clinical Results for Psoriasis
−Removed: We recently completed a Phase 1a POC trial of DMT310 for the treatment of mild-to-moderate psoriasis.
+Added: We completed a Phase 1a POC trial of DMT310 for the treatment of mild-to-moderate psoriasis.
This was an open-label, multi-center, 12-week study in 30 mild-to-moderate psoriasis patients with psoriatic lesions coving between 2-30% of body surface area.
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We are pleased with data already seen in our Phase 1 POC trial, especially seeing a reduction in itch as that is one of the main complaints of patients suffering from psoriasis.
−Removed: We are currently in the process of designing a Phase 2 study of DMT310 for the treatment of psoriasis.
+Added: We are in the process of designing a Phase 2 study of DMT310 for the treatment of psoriasis.
The Phase 2 study will be a larger randomized, double-blind, placebo control study of DMT310 for the treatment of psoriasis.
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We believe that the thicker psoriatic plaques may require a more intensive treatment compared to the application regimen for acne where there is no thickened skin.
−Removed: We believe DMT310 could be a first in class treatment option for psoriasis patients and plan to initiate the Phase 2 trial in 2022 with top-line results expected in 2023.
+Added: We believe DMT310 could be a first in class treatment option for psoriasis patients.
+Added: The DMT310 program for psoriasis is currently on hold with further advancement subject to obtaining additional financing and/or a strategic partner.
There can be no assurance that DMT310 will receive FDA approval for the treatment of psoriasis.
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There can be no assurances that DMT410 will receive FDA approval for the treatment of hyperhidrosis.
−Removed: DMT410 Phase 1b— Upper Facial Lines
+Added: DMT410 Phase 1b— Aesthetic Conditions
In November 2020, we enrolled our first patient in a Phase 1b open-label, POC trial of DMT410 for the treatment of upper facial lines along with multiple other aesthetic skin conditions that are affected by delivery of toxin to the dermis such as pore size, sebum production, brightness, luminosity, fine lines, and Global Aesthetic Improvement.
Due to the fact that we do not own rights to a botulinum toxin product, we were required by the FDA to conduct this trial using an approved indication for BOTOX, upper facial lines, an approved dose for this indication (64 units of botulinum toxin) and an approved route of administration, which is typically injections into the muscle rather than the dermis.
−Removed: However, we were interested in studying the clinical effect of DMT410 for the aesthetic skin conditions that require delivery of botulinum toxin to the dermis rather than the muscle, because of our belief that DMT410 only delivers botulinum toxin to the dermis and not the muscle.
+Added: However, our primary interest was studying the clinical effect of DMT410 for the aesthetic skin conditions that require delivery of botulinum toxin to the dermis rather than the muscle.
+Added: This is due to our belief that DMT410 only delivers botulinum toxin to the dermis and not the muscle, thus limiting the botulinum toxin’s effect to aesthetic conditions which arise in the dermis like fine lines, pore size, sebum production, and others.
With these constraints, we initiated the POC trial by enrolling ten (10) female patients, age 18 or older, each receiving one treatment of DMT410, consisting of one topical application of our proprietary sponge powder followed by one topical application for BOTOX, reconstituted per label, to the upper face.
12 unchanged sentences
Based on the assessment of forehead, lateral canthal, and glabellar lines, no patient was considered a responder in this study, while some patients did achieve at least a one-grade change throughout the course of the study.
−Removed: This result was not unexpected as BOTOX is only approved for injections into the muscle and we did not believe that we would see any potential distant spread of toxin outside of the dermis.
+Added: This result was not unexpected as BOTOX is only approved for injections into the muscle for these indications and we did not believe that we would see any potential distant spread of toxin outside of the dermis to the muscle.
Seeing no potential distant spread of toxin was encouraging for us as it provides important safety data that while DMT410 can be applied over a larger treatment area than injections, it does not appear to travel beyond the dermis which may cause unwanted facial effects.
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Our supplier has over 20 years of experience collecting and processing Spongilla and has the capacity to collect and process large quantities of Spongilla per year.
−Removed: We believe our supplier is able to harvest sufficient quantities of raw material to fulfill our development and potential commercial needs, if a product candidate is approved using this raw material.
+Added: We believe our supplier is able to and will continue to be able to harvest sufficient quantities of raw material to fulfill our development and potential commercial needs, if a product candidate is approved using this raw material.
+Added: We received two shipments of Spongilla raw material from our supplier during fiscal year 2022 containing additional quantities of Spongilla raw material, which we believe will provide us with sufficient quantities of Spongilla to initiate and complete two Phase 3 studies in moderate-to-severe acne and support the filing of a new drug application for DMT310 in acne in the event of successful completion of the two Phase 3 studies.
However, we are exploring alternative manufacturing sources in order to ensure that we have access to sufficient manufacturing capacity to meet potential demand for any of our product candidates in a cost-efficient manner.
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See “ Business – Clinical Progress of our Lead Product Candidates ” for the results of our completed and ongoing clinical trials.
−Removed: While we are unaware of any potential similar competitive topical products to DMT310 for the treatment of acne, psoriasis, and rosacea, it is possible that such potentially similar competitive products are currently being developed.
+Added: While we are unaware of any potential similar competitive topical products to DMT310 for the treatment of acne and psoriasis, it is possible that such potentially similar competitive products are currently being developed.
We are also in early stages of clinical development for DMT410 for treating various medical and aesthetic skin conditions and diseases, and if we obtain marketing approval in the future, we will compete with traditional therapies, such as topical products, oral products, in-office procedures, such as botulinum toxin injections, off-label drugs, over the counter medication and homeopathic remedies, as well as additional new entrants to the applicable markets.
1 unchanged sentence
Intellectual Property
−Removed: Our commercial success depends in part on our ability to obtain and maintain proprietary protection for DMT310, DMT410 and any of our future product candidates, medical devices, methodologies, assays, drug development technologies, harvesting procedures, know-how;
+Added: Our commercial success depends in part on our ability to obtain and maintain proprietary protection for DMT310, DMT400, DMT410 and any of our future product candidates, medical devices, methodologies, assays, drug development technologies, harvesting procedures, know-how;
to operate without infringing on or otherwise violating the proprietary rights of others;
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Additionally, the issued foreign patent in Japan, has lapsed and is no longer in force or valid.
−Removed: These patents are expected to expire between 2022 and 2023, absent any patent term adjustments or extensions.
+Added: These patents are expected to have expired or expire between 2022 and 2023, absent any patent term adjustments or extensions.
Based on the anticipated timing of any potential FDA approval of DMT310 for acne, the patents that expire in 2022 and 2023 are not material to our business, as we do not expect these patents to provide any protection for our product candidates.
11 unchanged sentences
Patents in this patent family, if granted are expected to expire in 2041, absent any patent term adjustments or extensions.
−Removed: Our DMT400 portfolio includes two families owned by Dermata.
+Added: Our DMT400 portfolio includes three families owned by Dermata.
The first family consists of pending applications in the U.S., Canada, and Japan covering our sponge powder in combination with many approved and development stage monoclonal antibodies for the treatment of skin diseases.
2 unchanged sentences
Patents in this patent family, if granted, are expected to expire in 2040, absent any patent term adjustments or extensions.
+Added: The third family consists of a pending PCT application filed in January of 2023, covering the compositions for the treatment of conditions by vaccines in combination with our proprietary sponge powder.
Although we believe our patent portfolio offers significant protection for DMT310, DMT410 and DMT400 and additional combination regimens, the protection offered by our patents may be, to some extent, more limited than the protection provided by patents which claim chemical structures which were previously unknown.
37 unchanged sentences
We paid to Villani $1.0 million upon the closing of our initial public offering.
−Removed: Supply Agreement between Dermata Therapeutics LLC and Reka-Farm LLC
+Added: Supply Agreement between the Company and Reka-Farm LLC
On February 27, 2020, we entered into an exclusive Supply Agreement (or, the Supply Agreement) with Reka-Farm, LLC (or, Reka-Farm), whereby Reka-Farm will supply us with the Spongilla raw materials necessary for use in the development of our product candidates.
8 unchanged sentences
The Supply Agreement includes customary terms relating to, among others, indemnification, intellectual property protection, confidentiality, remedies, warranties, as well as certain quality requirements.
+Added: Human Capital Resources
As of the date of this report, we have eight full time employees, with three employees working in the general and administrative department, two engaged in non-clinical and clinical development, two working in the chemistry, manufacturing and controls department, and one employee working in the regulatory affairs and quality control department.
+Added: We believe that our future success will depend, in part, on our continued ability to attract, hire and retain qualified personnel.
+Added: In particular, we depend on the skills, experience and performance of our senior management and research personnel.
+Added: We compete for qualified personnel with other medical pharmaceutical, and healthcare companies, as well as universities and non-profit research institutions.
+Added: We provide competitive compensation and benefits programs to help meet the needs of our employees.
+Added: In addition to salaries, these programs (which vary by country/region and employment classification) include incentive compensation plans, healthcare and insurance benefits, retirement investments, paid time off, and family leave, among others.
+Added: We also use targeted equity-based grants with vesting conditions to facilitate retention of personnel, particularly for our key employees.
+Added: The success of our business is fundamentally connected to the well-being of our people.
+Added: Accordingly, we are committed to the health and safety of our employees.
+Added: In response to the COVID-19 pandemic, we implemented significant changes that we determined were in the best interest of our employees, as well as the communities in which we operate, and which comply with government regulations.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.