Core Insights - Dermata Therapeutics announced positive topline results from the Phase 3 trial of XYNGARI™, a once-weekly topical treatment for moderate-to-severe acne, achieving significant clinical benefits [1][4][6] - XYNGARI™ is the first product of its kind to demonstrate clinical efficacy in a Phase 3 trial, addressing a significant market need as over 30 million acne patients seek treatment annually in the U.S. [1][9] Company Overview - Dermata Therapeutics is a late-stage biotechnology company focused on treating medical skin diseases and aesthetic applications, with XYNGARI™ being its lead product candidate [10][11] - The company is headquartered in San Diego, California, and is developing XYNGARI™ from its Spongilla technology platform, which utilizes a naturally sourced freshwater sponge [10][11] Clinical Trial Details - The Phase 3 STAR-1 trial was a randomized, double-blind, placebo-controlled study involving 520 patients aged 9 and older, evaluating the efficacy, safety, and tolerability of XYNGARI™ [5] - The primary endpoints included mean changes in inflammatory and non-inflammatory lesion counts and the Investigator Global Assessment (IGA) treatment response [5] Efficacy Results - At Week 12, 29.4% of patients treated with XYNGARI™ achieved a 2-point reduction in IGA score, compared to 15.2% in the placebo group, with a p-value of less than 0.001 [6][7] - The mean change from baseline in inflammatory lesion count was -16.8 for XYNGARI™ versus -13.1 for placebo, and for non-inflammatory lesions, it was -17.3 for XYNGARI™ versus -12.4 for placebo, both with p-values less than 0.001 [6][7] Future Plans - Following the positive results from the STAR-1 trial, Dermata plans to initiate the second Phase 3 trial, STAR-2, in the second half of 2025, which will be followed by an open-label extension study [4][6] - Successful outcomes from the Phase 3 program could support a new drug application filing with the U.S. Food and Drug Administration [5][6]