Dermata Therapeutics, Inc. (NASDAQ:DRMA) has achieved a key milestone in the development of Xyngari (formerly DMT310), its Phase 3 clinical drug candidate for acne treatment, with the U.S. Food and Drug Administration (FDA) approving the proprietary name Xyngari. This approval is contingent upon the successful submission and acceptance of a new drug application (NDA). The company anticipates topline results from the first Phase 3 STAR-1 study in March 2025.
The Xyngari Phase 3 STAR-1 (Spongilla Treatment of Acne Research) clinical study is designed to evaluate the efficacy, safety, and tolerability of Xyngari in patients aged 9 years and older with moderate-to-severe facial acne. The study is a randomized (2:1), double-blind, and placebo-controlled trial involving 520 patients across the United States and Latin America.
Study Design and Endpoints
The STAR-1 study involves a 12-week treatment period where patients receive either Xyngari or a placebo once weekly. Evaluations are conducted monthly. The primary endpoints of the study include the mean change from baseline in both inflammatory and noninflammatory lesion counts. Additionally, the Investigator Global Assessment (IGA) treatment response is a key endpoint, measured on a 5-point scale (0-4), with treatment response defined as at least a 2-point improvement from baseline and an IGA score of 0 (clear) or 1 (almost clear).
Potential Impact of Xyngari
According to Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer, the FDA's approval of the Xyngari name is a significant step forward in the development program. He believes that with the upcoming Phase 3 acne topline results and the recent notice of allowance of a U.S. patent covering Xyngari for acne treatment, Dermata is well-positioned to complete the development program and eventually file an NDA. If approved, Xyngari has the potential to be the first safe, effective, once-weekly topical product for treating acne, presenting a substantial commercial opportunity.
Xyngari's Novel Mechanism of Action
Xyngari is derived from a freshwater sponge and is designed as a novel, once-weekly, topical treatment for various skin diseases. Its mechanism of action involves both mechanical components and chemical compounds that address inflammatory skin conditions like acne. The processed sponge powder contains silica spicules that may exfoliate the skin, promote collagen production, open closed comedones, and create microchannels to facilitate the penetration of naturally occurring chemical compounds. These compounds have demonstrated antimicrobial and anti-inflammatory properties in vitro, which may significantly contribute to treating inflammatory skin diseases.
Prior Clinical Evidence
In a previous Phase 2b study, Xyngari demonstrated a statistically significant treatment effect in moderate-to-severe acne with once-weekly applications, achieving significant results at all timepoints for all primary and secondary endpoints. Almost 45% of patients achieved an IGA score of clear or almost clear, compared to less than 18% in the placebo group.
Dermata's Broader Pipeline
Dermata Therapeutics is also developing DMT410, which utilizes Xyngari for needle-free intradermal delivery of botulinum toxin to treat various aesthetic and medical skin conditions. The company is headquartered in San Diego, California.
Acne Vulgaris: A Widespread Condition
Acne vulgaris affects over 30 million people in the U.S. seeking treatment annually. Approximately 85% of teenagers experience some form of acne, and many individuals continue to suffer from acne into their 30s, 40s, and beyond. Acne is characterized by scaly red skin, noninflammatory blackheads and whiteheads, inflammatory papules and pustules, and occasionally cysts and scarring, which can occur on the face, neck, chest, back, shoulders, and upper arms. While not life-threatening, acne can cause significant psychological distress due to social stigmas, the risk of permanent facial scarring, lowered self-esteem, and social withdrawal.
