Dermata Therapeutics, Inc. (Nasdaq:DRMA) is making significant strides with its focus on medical and aesthetic skin conditions. Recently, Dermata announced the successful enrollment of 50% of patients in its pivotal Phase 3 STAR-1 study for DMT310, a novel, once-weekly topical treatment for moderate-to-severe acne.
This study, which began in December 2023, aims to confirm the safety and efficacy observed in earlier trials and, if successful, will support a new drug application for DMT310. DMT310, derived from a freshwater sponge, offers multiple mechanisms of action, including exfoliation, collagen promotion, and antimicrobial properties. In Phase 2b studies, DMT310 showed promising results, with nearly 45% of patients achieving clear or almost clear skin compared to less than 18% in the placebo group.
The Phase 3 clinical program for DMT310 includes two trials with approximately 550 patients each, focusing on efficacy, safety, and tolerability. The primary endpoints are improvements in lesion counts and Investigator Global Assessment scores. If positive, these results will support the filing of an NDA with the FDA. Acne affects over 30 million people annually in the U.S., causing significant psychological and social impacts. Dermata’s innovative approach with DMT310 aims to address this widespread condition with a new, effective treatment option.
Headquartered in San Diego, Dermata is dedicated to developing treatments for skin conditions using its Spongilla technology platform. In addition to acne, DMT310 is being studied for psoriasis and rosacea. The company’s second product, DMT410, leverages this technology for needle-free delivery of botulinum toxin. For more information, visit Dermata Therapeutics.