Enrollment of patients in DMT 310 phase III acne clinical program to begin in December 2023 based on agreement with FDA on the phase III protocols.-Dermata Therapeutics.

This agreement allows the Company to initiate the Phase III clinical trial program, with plans to begin enrolling patients in the first Phase III clinical trial in December 2023.

DMT 310 Phase III Clinical Trial Design: The DMT 310 Phase III clinical program will include two Phase III clinical trials to evaluate the efficacy, safety, and tolerability of DMT 310 in patients with moderate-to-severe facial acne. Each Phase III 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 primary endpoints are the mean change from baseline in inflammatory and noninflammatory lesion counts and the Investigator Global Assessment (IGA) response rate. IGA is measured on a 5-point scale (0-4), with a treatment response defined as a 2-point improvement from baseline and an IGA score of 0 (clear) or 1 (almost clear). Patients will be treated once weekly for 12 weeks with either DMT 310 or placebo and will be evaluated monthly. The first of two pivotal Phase III trials, STAR-1, is planned to begin enrolling patients by the end of 2023. If positive, the results from both Phase III clinical trials will be used to support the filing of an NDA with FDA.