Dermata Therapeutics, Inc (DRMA) Reports Positive Results from Phase 1b Clinical Trial of DMT310 for the Treatment of Mild-to-Moderate Psoriasis

Dermata Therapeutics, Inc. (NASDAQ: DRMA), a clinical-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions, today announced positive topline results from its Phase 1b trial of DMT310 in 30 patients as a once-weekly topical application for the treatment of mild-to-moderate psoriasis. DMT310 is Dermata's lead product candidate, with both mechanical and chemical mechanisms of action, currently being investigated to treat multiple inflammatory skin conditions, including acne, psoriasis, and rosacea.

"The objectives of our single-arm Phase 1b study of DMT310 in psoriasis were two-fold: to assess the safety and tolerability of DMT310 in psoriasis patients and to look for an efficacy signal with once-weekly treatments in mild-to-moderate psoriasis patients," said Gerry Proehl, Dermata's Chairman, President and Chief Executive Officer. "I am pleased to report that we achieved both objectives in that treatment with DMT310 appears to be safe and well tolerated by psoriasis patients, and that DMT310 demonstrated efficacy improvements in PGA, PASI, and pruritis scores for the target psoriatic lesion. Based upon the improvements witnessed across all three of our exploratory endpoints, combined with the tolerability profile observed and the continued need for safe and effective topical products for the treatment of psoriasis, we plan to continue investigation of DMT310 in psoriasis."

DMT310 Phase 1b Topline Results

• The percentage of treatment responders in 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 total Psoriasis Area Severity Index (PASI) was 25.9% at Week 8.
• Treatment with DMT310 resulted in a change from baseline in pruritis of -19.6% for the target lesion at Week 8.
• DMT310 appeared to be safe with only three reported adverse events (AEs), with only two of the three AEs evaluated as being related to treatment, and no reported serious adverse events (SAEs).
• Dermata intends to submit results from this Phase 1b study at a future medical meeting or in a publication.

"Due to the mechanical components of DMT310, we were unsure how psoriasis patients would tolerate the treatment, but after observing a majority of patients in the Phase 1b study having no tolerability issues throughout the study and only a handful of patients having mild or moderate issues, we believe that the treatment application and regimen can be further optimized to increase the treatment effect," said Christopher Nardo, Ph.D., Dermata's Senior Vice President, Development. "Importantly, the treatment effect and tolerability observed in this Phase 1b target lesion study provides support for exploring a treatment regimen with more frequent than once-weekly applications, improved application techniques, or more drug per application site, which could be more effective for moderate psoriasis patients with thicker psoriatic plaques. Therefore, we have initiated additional work in an ex vivo skin model to evaluate dosing frequency and product application to better inform the clinical trial design for a future Phase 2 psoriasis study."

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