Dermata Therapeutics has achieved a significant milestone in acne treatment development, announcing that its lead product candidate XYNGARI met all three co-primary endpoints in the Phase 3 STAR-1 clinical trial for moderate-to-severe acne. The San Diego-based biotechnology company reported that XYNGARI achieved statistically significant results versus placebo at both the FDA-required 12-week primary endpoint and as early as week 4, representing the earliest measured timepoint in the study.
"We are very excited to have received the full data set from our Phase 3 STAR-1 trial of XYNGARI showing that XYNGARI achieved statistically significant results for its three co-primary endpoints at weeks 4 and 12," commented Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. "We believe these data show that not only does XYNGARI work after the FDA required 12-week primary endpoint, but it also works as early as week four, which was the earliest measured timepoint."
Novel Spongilla Technology Platform
XYNGARI represents the first product candidate developed from Dermata's proprietary Spongilla technology platform. The treatment is a once-weekly, topical product candidate derived from a naturally sourced freshwater sponge with multiple unique mechanisms of action. Beyond acne, XYNGARI has been studied for the treatment of psoriasis and rosacea, demonstrating the platform's potential versatility in dermatological applications.
The positive STAR-1 results mark the completion of the first of two required Phase 3 clinical trials. The company is now evaluating next steps for the XYNGARI Phase 3 STAR-2 clinical trial in moderate-to-severe acne, which would be followed by a 9-month extension study. Completion of both Phase 3 trials and the extension study would be necessary before filing a new drug application with the U.S. Food and Drug Administration.
Financial Position and Pipeline Development
Dermata strengthened its financial position during the first half of 2025, raising $8.8 million in gross proceeds from private placement and warrant inducement financings. As of June 30, 2025, the company held $6.5 million in cash and cash equivalents, compared to $3.2 million at the end of 2024. The company expects its current cash resources to fund operations into the second quarter of 2026.
The company's research and development expenses decreased significantly to $0.6 million for the second quarter of 2025, compared to $2.0 million for the same period in 2024. This $1.4 million decrease primarily resulted from $1.6 million in reduced clinical expenses following completion of the STAR-1 study, partially offset by increased chemistry, manufacturing, and controls expenses.
Expanding Treatment Applications
Dermata is also advancing DMT410, its second product candidate that utilizes XYNGARI as a novel method for needle-free intradermal delivery of botulinum toxin. The company continues collaborating with Revance on the final study design and start-up procedures for a Phase 2a clinical study of XYNGARI with DAXXIFY for the topical treatment of axillary hyperhidrosis. This approach represents a potential breakthrough in delivering botulinum toxin treatments for multiple aesthetic applications and medical skin diseases including hyperhidrosis, acne, and rosacea.
The successful Phase 3 results position XYNGARI as a potentially significant advancement in acne treatment, offering patients a once-weekly topical option derived from natural sources. With the company's strengthened financial position and clear regulatory pathway ahead, Dermata appears well-positioned to advance its novel dermatological treatments toward potential market approval.
