Dermata Therapeutics, Inc. announced that it has successfully enrolled 50% of patients in its pivotal Phase 3 Spongilla Treatment for Acne Research (STAR-1) study of DMT310, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne. The STAR-1 study is the first of two Phase 3 studies that, if positive, would be used by the Company to support the filing of a new drug application (NDA) for DMT310 for the treatment of moderate- to-severe acne. 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 patients with moderate-to- severe acne, ages 9 years and older in the United States and Latin America. Patients will be treated once a week for 12 weeks with either DMT310 or placebo and will be evaluated monthly. STAR-1 is the first of two pivotal Phase 3 trials, of which the second Phase 3 study will be followed by a long-term extension study.

If positive, the results from the Phase 3 program would be used to support the filing of an NDA with FDA.