Dermata Therapeutics, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) on the DMT310 Phase 3 clinical protocols for the treatment of acne. This agreement allows the Company to initiate the Phase 3 clinical trial program, with plans to begin enrolling patients in the first Phase 3 clinical trial in December 2023. The DMT310 Phase 3 clinical program will include two Phase 3 clinical trials to evaluate the efficacy, safety, and tolerability of DMT310 in patients with moderate-to-severe facial acne.

Each Phase 3 trial will be randomized (2:1), double-blind, and placebo-controlled, enrolling approximately 550 acne patients ages 9 years and older in the United States and Latin America. The first of two pivotal Phase 3 trials, STAR-1, is planned to begin enrolling patients by the end of 2023. If positive, the results from both Phase 3 clinical trials will be used to support the filing of an NDA with FDA.

DMT310 is a novel, once-weekly, topical product candidate derived from a freshwater sponge being developed for the treatment of multiple skin diseases. It has multiple mechanisms of action that include mechanical components and chemical compounds to help treat inflammatory skin diseases, like acne. After processing, the sponge powder contains precisely sized and shaped silica spicules that upon application may help exfoliate the skin, promote collagen production, open closed comedones (creating an aerobic environment to help kill C. acne bacteria), and create microchannels to facilitate penetration of the sponge's naturally occurring chemical compounds.

These chemical compounds have been shown, in-vitro, to have both antimicrobial and anti-inflammatory properties, which may play a significant role in the treatment of inflammatory skin diseases. DMT310 has previously shown its treatment effect in moderate-to-severe acne in a Phase 2b study where DMT310 applied once weekly, achieved statistically significant results at all timepoints for all primary and secondary endpoints. DMT310 also observed almost 45% of patients achieve an IGA score of clear or almost clear compared with less than 18% of placebo patients achieving the same at the end of 12 weeks.

Acne affects approximately 50 million people in the U.S., with about 85% of teenagers experiencing some form of acne, and some individuals suffering from acne well into their 30s, 40s, and beyond. Acne is characterized by areas of scaly red skin, noninflammatory blackheads and whiteheads, inflammatory papules and pustules, and occasionally cysts and scarring, which can present on the face, neck, chest, back, shoulders, and upper arms. While not life-threatening, acne can cause significant trauma for those suffering from it due to social stigmas, substantial risk of permanent facial scarring, lowered self-esteem, and social withdrawal.