Dermata’s XYNGARI Nails Phase 3: A Once-Weekly Acne Breakthrough

March 27, 2025

DENVER, Colo., Mar 27, 2025 (247marketnews.com)- Dermata Therapeutics (NASDAQ:DRMA) just reported that XYNGARI, its once-weekly topical acne fighter, aced its first pivotal Phase 3 trial, hitting all primary endpoints with blockbuster stats. Targeting the 30 million U.S. acne sufferers, this sponge-derived marvel, the first weekly topical to prove itself in a Phase 3 study, promises a game-changer for moderate-to-severe acne, blending efficacy with a safety profile that’s as clean as its results.

Dr. Sunil Dhawan, MD, FAAD, FACP, clinical investigator at the Center for Dermatology Clinical Research, Inc., a participating site in the STAR-1 trial, commented, “I believe having a once-weekly topical product with a strong efficacy and safety profile, like XYNGARI, would be a great addition to a dermatologist’s arsenal for treating acne.

“All FDA approved topical acne products are required to be applied at least once or twice a day, which may reduce patient compliance, so I believe having a once-weekly topical acne product like XYNGARI™ could lead to improved patient compliance.”

The STAR-1 trial, a 520-patient, double-blind, placebo-controlled showdown across the U.S. and Latin America, tested XYNGARI against placebo over 12 weeks. It crushed it: 29.4% of XYNGARI patients (vs. 15.2% placebo) hit “clear” or “almost clear” on the Investigator Global Assessment (IGA), with a p-value < 0.001. Inflammatory lesions dropped by 16.8 (vs. 13.1 placebo), and non-inflammatory by 17.3 (vs. 12.4 placebo)—both p < 0.001.

Gerry Proehl, Dermata’s Chairman, President, and CEO, stated, “We are incredibly excited about these Phase 3 clinical trial results for XYNGARI, which we believe reinforce its potential as a unique acne treatment, distinct from any existing product on the market. The highly statistically significant efficacy data not only confirms the results of our Phase 2b acne study but also strengthens our confidence about the upcoming XYNGARI Phase 3 STAR-2 trial, set to launch in the second half of 2025. With these positive Phase 3 clinical trial results, we are eager to advance discussions with potential partners interested in securing future rights to XYNGARI.”

XYNGARI, born from freshwater sponge silica and chemical magic, exfoliates, kills bacteria, and calms inflammation, a triple-threat with no daily topical matches.

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