Dermata Therapeutics, Inc. (NASDAQ: DRMA), a biotechnology company specializing in medical and aesthetic dermatology, has received approval from the U.S. Food and Drug Administration (FDA) for the proprietary name “Xyngari” for its acne treatment candidate, formerly known as DMT310. The approval of the name is contingent upon the successful submission and acceptance of a New Drug Application (NDA). This milestone comes as Dermata prepares for the topline results from its pivotal Phase 3 STAR-1 clinical trial, expected in March 2025.
The Phase 3 STAR-1 study is a randomized, double-blind, placebo-controlled trial involving 520 patients with moderate-to-severe facial acne. The study evaluates a once-weekly treatment regimen over 12 weeks, with primary endpoints focusing on changes in lesion counts and Investigator Global Assessment (IGA) scores. The trial represents a crucial step in the development of Xyngari, which could potentially be the first once-weekly topical treatment for acne, offering a significant competitive advantage in the crowded acne treatment market.
Dermata’s Chairman and CEO, Gerry Proehl, emphasized the importance of the FDA’s approval of the product name, calling it “one more successful step in the development program” for Xyngari. He also highlighted the commercial potential of the treatment, noting its promise as “the first safe, effective, once-weekly, topical product to treat acne.”
The STAR-1 trial is the first of two Phase 3 studies required by the FDA for NDA submission. The study, which includes patients from the United States and Latin America, will measure efficacy through inflammatory and non-inflammatory lesion counts as well as the IGA treatment response, which tracks improvements in acne severity. A second Phase 3 study, followed by an extension trial, will be necessary before Dermata can file for FDA approval.
Xyngari, which is derived from a freshwater sponge, utilizes multiple mechanisms of action, including mechanical exfoliation and antimicrobial and anti-inflammatory properties. Previous Phase 2b trials demonstrated significant efficacy, with nearly 45% of patients achieving an IGA score of “clear” or “almost clear,” compared to less than 18% for placebo patients.
For a company with a market capitalization of just $2.2 million, Dermata’s ambitious approach to the acne treatment market underscores its commitment to developing novel therapies. However, the extended timeline to commercialization, with topline results not expected until March 2025 and additional trials required, presents financial challenges. Success in the STAR-1 trial is a critical factor in securing future investment and achieving commercialization goals.
In addition to its acne treatment program, Dermata is also developing DMT410, a needle-free delivery method for botulinum toxin aimed at treating various aesthetic and medical skin conditions.
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