Dermata Therapeutics, Inc.’s freshwater sponge-based acne treatment met all primary endpoints in a Phase 3 trial, according to topline results.
Xyngari is derived from a natural source of Spongilla lacustris, which contains multiple active components to treat a variety of inflammatory skin diseases. After processing, the sponge powder contains precisely sized and shaped silica spicules that, upon application, may help exfoliate the skin, promote collagen production, open closed comedones (creating an aerobic environment to help kill C. acne bacteria), and create microchannels to facilitate penetration of the sponge’s naturally occurring chemical compounds. The topical product is applied once weekly.
The Xyngari Phase 3 Spongilla Treatment for Acne Research (STAR-1) trial evaluated the efficacy, safety, and tolerability of Xyngari in patients with moderate-to-severe facial acne. The STAR-1 study was a randomized (2:1), double-blind, and placebo-controlled study that enrolled 520 patients with moderate-to-severe acne, aged 9 and up in the United States and Latin America. The primary endpoints include the mean change from baseline in inflammatory and noninflammatory lesion counts and the Investigator Global Assessment (IGA) treatment response. IGA is measured on 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 0 (clear) or 1 (almost clear). Patients were treated once a week for 12 weeks with either Xyngari or placebo and were evaluated monthly.
Met All Three Primary Endpoints
Xyngari met all three primary endpoints by achieving a statistically significant difference when compared with placebo after 12 weeks of once-weekly treatments with Xyngari.
The STAR-1 study is the first of two pivotal Phase 3 studies, with the second Phase 3 study to be followed by an extension study. If positive, the results of the Phase 3 program would be used to support the filing of a new drug application with the U.S. Food and Drug Administration.
“I believe having a once-weekly topical product with a strong efficacy and safety profile, like XYNGARI™, would be a great addition to a dermatologist’s arsenal for treating acne,” says Sunil Dhawan, MD, clinical investigator at the Center for Dermatology Clinical Research, Inc., a participating site in the STAR-1 trial, in a news release. “All FDA-approved topical acne products are required to be applied at least once or twice a day, which may reduce patient compliance, so I believe having a once-weekly topical acne product like Xyngari could lead to improved patient compliance.”
“We are incredibly excited about these Phase 3 clinical trial results for XYNGARI, which we believe reinforce its potential as a unique acne treatment, distinct from any existing product on the market,” adds Gerry Proehl, Chairman, President, and Chief Executive Officer of Dermata. “The highly statistically significant efficacy data not only confirms the results of our Phase 2b acne study but also strengthens our confidence about the upcoming XYNGARI Phase 3 STAR-2 trial, set to launch in the second half of 2025. With these positive Phase 3 clinical trial results, we are eager to advance discussions with potential partners interested in securing future rights to XYNGARI.”
