Dermata's DMT310 Acne Trial Achieves Key Enrollment Benchmark!

Dermata Therapeutics, Inc., a late-stage biotech firm specializing in medical and cosmetic skin treatments, announced today that it has reached the halfway mark in patient enrollment for its critical Phase 3 STAR-1 (Spongilla Treatment for Acne Research) trial. This trial is testing DMT310, an innovative, once-a-week topical solution designed to treat moderate-to-severe acne. STAR-1 is the first of two Phase 3 trials that, if successful, will be used to file a new drug application (NDA) for DMT310.

Dr. Nardo said, “We are excited by the enrollment progress seen in the STAR-1 study since enrolling our first patient in December 2023 and want to thank all those patients for their participation in the study," said Christopher Nardo, Ph.D., Dermata's Chief Development Officer. "With all clinical sites activated, we expect to continue our enrollment momentum in the coming months and expect to announce topline data from the STAR-1 study in the first quarter of 2025.”

He further added, “Investigators continue to be enthusiastic about DMT310 and its potential to be the first approved once-weekly, topical product for the treatment of moderate-to-severe acne as there continues to be a need for safe and effective treatment options. We believe that if the DMT310 Phase 3 program confirms the safety and efficacy observed in our Phase 2b acne study, that if approved, DMT310 could become a first line therapy for the treatment of moderate-to-severe acne.”

The Phase 3 clinical program for DMT310 will encompass two pivotal trials to assess its efficacy, safety, and tolerability in patients with moderate-to-severe facial acne. Both trials will be randomized in a 2:1 ratio, double-blind, and placebo-controlled. They aim to enroll around 550 participants aged 9 and above from the United States and Latin America, all suffering from moderate-to-severe acne. The main objectives are to measure the mean change from baseline in both inflammatory and noninflammatory lesion counts and to evaluate the treatment response using the Investigator Global Assessment (IGA) scale.

The IGA uses a 5-point scale (0-4), with a treatment response defined as at least a 2-point improvement from baseline and an IGA score of either 0 (clear) or 1 (almost clear). Patients will receive weekly treatments of either DMT310 or a placebo for 12 weeks and will undergo monthly evaluations. The first of these pivotal trials, named STAR-1, will be followed by a second Phase 3 study and a subsequent long-term extension study. Positive outcomes from this program will support the submission of a New Drug Application (NDA) to the FDA.