The last patient has completed their last visit in Dermata Therapeutics, Inc.’s first pivotal Phase 3 Spongilla Treatment for Acne Research (STAR-1) trial of Xyngari, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne.
The Company remains on track to announce topline data by the end of March 2025.
Xyngari is derived from a natural source of Spongilla lacustris, which contains multiple active components to treat a variety of inflammatory skin diseases including acne, psoriasis, and papulopustular rosacea with once weekly applications. 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.
“This is a great milestone for our team, as we continue to examine the acne market, we believe there is still a high unmet need by patients for an acne product like XYNGARI,” says Gerry Proehl, Dermata’s Chairman, President, and Chief Executive Officer, in a news release. “Unlike traditional acne therapies, XYNGARI is designed as a once-weekly, natural, topical treatment with multiple mechanisms of action that target the root causes of acne. We believe XYNGARI acts by reducing inflammation, unclogging pores, and addressing both the inflammatory and noninflammatory lesions, thereby having the potential to provide a more effective, convenient, and well-tolerated alternative to current acne treatments. If approved by FDA, XYNGARI could change the standard of care of millions of patients struggling with acne.”
The XYNGARI Phase 3 STAR-1 clinical study will evaluate 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 enrolling 520 patients with moderate-to-severe acne, ages 9 and older 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.
The STAR-1 study is the first of two pivotal Phase 3 studies, of which the second Phase 3 study will be followed by an extension study. If positive, the results the Phase 3 program would be used to support the filing of a new drug application with the U.S. Food and Drug Administration.
