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Dermata Therapeutics, Inc. (NASDAQ:DRMA)(NASDAQ:DRMAW) ("Dermata" or the "Company"), a late-stage biotechnology company focusing on the treatment of medical and aesthetic skin diseases and conditions, today announced that it received approval from U.S. Food and Drug Administration (FDA) of the proprietary name, Xyngari (pronounced zin-gar-ee) (formerly DMT310), 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 (NDA).
"The FDA approving the Xyngari name is just one more successful step our team has completed in the development program for this unique product candidate," commented Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. "Having an approved proprietary name with the approaching Phase 3 acne topline results expected in March 2025, and recent notice of allowance of a US patent covering Xyngari for the treatment of acne, we believe, positions Dermata well to complete this development program and eventually file an NDA. Our team is excited about the prospect of making Xyngari available to patients, if approved, as we see great commercial opportunity for Xyngari, as it is potentially the first safe, effective, once-weekly, topical product to treat acne," concluded Mr. Proehl.
Xyngari Phase 3 STAR-1 Clinical Study Design
The Xyngari Phase 3 Spongilla Treatment of Acne Research (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 is a randomized (2:1), 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 (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 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.
About Xyngari (formerly DMT310)
Xyngari is a novel, once-weekly, topical product candidate derived from a freshwater sponge being developed for the treatment of multiple skin diseases. Xyngari has multiple mechanisms of action that include mechanical components and chemical compounds to help treat inflammatory skin diseases, like acne. 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. These chemical compounds have been shown, in-vitro, to have both antimicrobial and anti-inflammatory properties, which may play a significant role in the treatment of inflammatory skin diseases. Xyngari has previously shown its treatment effect in moderate-to-severe acne in a Phase 2b study where once weekly applications achieved statistically significant results at all timepoints for all primary and secondary endpoints. Xyngari also saw almost 45% of patients achieving an IGA score of clear or almost clear compared with less than 18% for placebo patients.