Dermata Therapeutics receives FDA approval for Xyngari proprietary name

Dermata Therapeutics (DRMA) received approval from U.S. Food and Drug Administration of the proprietary name, Xyngari, for its Phase 3 clinical drug candidate in acne. The proprietary name, Xyngari, is approved pending the successful submission and acceptance of a new drug application. The Xyngari Phase 3 Spongilla Treatment of Acne Research clinical study will evaluate the efficacy, safety, and tolerability of Xyngari in patients with moderate-to-severe facial acne. The STAR-1 study is a randomized, double-blind, and placebo-controlled study with 520 patients enrolled with moderate-to-severe acne, ages 9 years 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 treatment response. IGA is measured on a 5-point scale, with a treatment response defined as at least a 2-point improvement from baseline and an IGA score of 0 or 1. Patients are treated once-a-week for 12 weeks with either Xyngari or placebo and are evaluated monthly. The STAR-1 study is the first of two pivotal Phase 3 studies required by the FDA, of which the second Phase 3 study will be followed by an extension study. If positive, the results from both Phase 3 studies would be used to support the filing of an NDA with FDA.