– DMT310 obtained a PGA score of 0 or 1 for the target lesion in 29.6% of patients at week 8 –
– DMT310 demonstrated a total PASI score of 0 or 1 for the target lesion in 25.9% of patients at week 8 –
– DMT310 demonstrated a 19.6% reduction from baseline for pruritus at week 8 –
– Phase 1b results support further study of DMT310 in psoriasis –
SAN DIEGO, CA / ACCESSWIRE / October 18, 2021 / Dermata Therapeutics, Inc. (“Dermata” or the “Company”) (NASDAQ: DRMA), a clinical-stage biotechnology company focused on the treatment of medical and aesthetic skin conditions, today announced the first positive results of its Phase 1b trial of DMT310 in 30 patients topically applied once weekly for the treatment of mild to moderate psoriasis. DMT310 is Dermata’s flagship product candidate, with both mechanical and chemical mechanisms of action, currently under investigation to treat multiple inflammatory skin conditions, including acne, psoriasis and rosacea.
“The objectives of our phase 1b single-arm study of DMT310 in psoriasis were twofold: to assess the safety and tolerability of DMT310 in patients with psoriasis and to look for a signal of efficacy with once-weekly treatments in mild to moderate psoriasis. patients, ”said Gerry Proehl, Chairman, President and CEO of Dermata. “I am pleased to report that we have achieved both goals in that treatment with DMT310 appears to be safe and well tolerated by patients with psoriasis, and that DMT310 has demonstrated improvements in efficacy in scores. PGA, PASI and pruritus for the target psoriatic lesion. Improvements observed on our three exploratory endpoints, combined with the observed tolerability profile and the continued need for safe and effective topical products for the treatment of psoriasis, we plan to continue the study of DMT310 in psoriasis. “
First-line results of DMT310 Phase 1b
The percentage of responders to treatment in the Physician’s Global Assessment (PGA) with a score of 0 or 1 was 29.6% at week 8.
The percentage of patients with a score of 0 or 1 in the Total Psoriasis Area Severity Index (PASI) was 25.9% at week 8.
Treatment with DMT310 resulted in a change from inclusion of pruritus of -19.6% for the target lesion at week 8.
DMT310 appeared safe with only three adverse events (AEs) reported, with only two of the three AEs assessed as treatment-related, and no serious adverse events (SAEs) were reported.
Dermata intends to submit the results of this Phase 1b study at a future medical meeting or in a publication.
“Due to the mechanical components of DMT310, we did not know how patients with psoriasis would tolerate the treatment, but after observing a majority of patients in the phase 1b study having no safety issues throughout the ‘study and only a handful of patients with mild to moderate problems, we believe that the application and regimen of treatment can be further optimized to increase the effect of treatment, ”said Christopher Nardo, Ph.D., vice -President, Dermata Development. “It is important to note that the treatment effect and tolerability observed in this phase 1b study on target lesions allows exploration of a treatment regimen with more frequent applications than once. per week, improved application techniques or more drug per application site, which may be more effective for moderate patients. psoriasis patients with thicker psoriatic plaques. Therefore, we initiated additional work in an ex vivo skin model to assess the frequency of administration and application of the product to better inform the clinical trial design for a future phase 2 study in psoriasis. . “
DMT310 Phase 1b Trial Design
The Phase 1b study was a 12-week, multi-center, open-label, single-arm, proof-of-concept trial in target lesions designed to assess the safety, tolerability and efficacy of weekly administration of DMT310 in 30 patients with moderate to moderate psoriatic plaque covering 2% to 30% of body surface area. DMT310 was applied once per week to a designated target lesion with patients assessed 1 week, 4 weeks, 8 weeks and 12 weeks after application.
DMT310 is Dermata’s flagship product candidate that incorporates the Spongilla technology to locally treat a variety of skin conditions. DMT310 is a multifactorial product naturally derived from a unique freshwater sponge that is harvested under specific environmental conditions and then processed into a powder. The powder is mixed with a thinning agent just before application. The organic components of DMT310 contain chemical compounds which, when tested in vitro, showed dose-dependent inhibition of IL-17A and IL-17F, which are considered to be major effector cytokines in the pathogenesis of psoriasis.
Dermata Therapeutics, Inc. is a clinical-stage biotechnology company specializing in the treatment of medical and cosmetic skin conditions. The Company’s flagship product candidate, DMT310, is the first product candidate developed from its Spongilla technology platform. DMT310 is in clinical development for the treatment of acne, psoriasis and rosacea. Dermata’s second product candidate, DMT410, uses its Spongilla technology as a novel method of topical intradermal administration of botulinum toxin for the treatment of multiple aesthetic and medical indications of the skin. Dermata is headquartered in San Diego, California. For more information, please visit http://www.dermatarx.com/.
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are based on the Company’s current beliefs and expectations and new risks may arise from time to time. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors, including, but not limited to, statements relating to: the potential development and commercialization of the DMT310 product candidate in the psoriasis; when, if any, additional psoriasis studies can take place; the design of the additional studies to be carried out; whether the first results of phase 1b of DMT310 in psoriasis will be indicative of the potential clinical outcome of DMT310; the safety and tolerability profile of DMT310; and the Company’s ability to obtain financing for the operation, development and commercialization of DMT310. These statements are only forecasts based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of these statements due to various factors, including the risks and uncertainties inherent in the development, approval and marketing of drugs, and the fact that past results of clinical trials may not be indicative of future trials. results. For a discussion of these and other factors, please refer to the documents filed by Dermata with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Dermata makes no commitment to revise or to update this press release to reflect events or circumstances. after the date hereof, except as required by law.
Senior Director, Legal and Business Development
THE SOURCE: Dermata Therapeutics
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