Xyngari found beneficial for Moderate to Severe Acne in Phase 3 Trial

Topline results were announced from a phase 3 trial evaluating Xyngari (formerly DMT310), a novel topical treatment derived from a freshwater sponge. It was found that XYNGARI™ a first once-weekly topical treatment had clinical effectiveness for moderate-to-severe acne.

The XYNGARI™ Phase 3 Spongilla Treatment for Acne Research (STAR-1) trial met all three primary endpoints by achieving a statistically significant difference when compared with placebo after 12 weeks of once weekly treatments with XYNGARI™.

"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," commented Dr. Sunil Dhawan, MD, FAAD, FACP, clinical investigator at the Center for Dermatology Clinical Research, Inc., a participating site in the STAR-1 trial. "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," concluded Dr. Dhawan.

"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," said Gerry Proehl, Chairman, President, and Chief Executive Officer of Dermata. "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™," Mr. Proehl added.

XYNGARI™ Phase 3 STAR-1 Clinical Study Design

The XYNGARI™ Phase 3 STAR-1 clinical study evaluated the efficacy, safety, and tolerability of XYNGARI™ in patients with moderate-to-severe facial acne. The STAR-1 study was a randomized (2:1), double-blind, and placebo-controlled study which enrolled 520 patients 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 were treated once-a-week for 12 weeks with either XYNGARI™ or placebo and were evaluated monthly. The STAR-1 study is the first of two pivotal Phase 3 studies, with the second Phase 3 study to be followed by an extension study. If positive, the results of the Phase 3 program would be used to support the filing of a new drug application with the U.S. Food and Drug Administration.

XYNGARI™ Phase 3 STAR-1 Topline Efficacy Results

In the intent to treat analysis, Dermata saw statistically significant differences in IGA treatment success, inflammatory lesion count, and non-inflammatory lesion count at Week 12 (study end) when compared to placebo.

"We wish to thank the study subjects and investigators for their participation in our study, as we could not have had this success without them," states Christopher Nardo, Ph.D., Chief Development Officer of Dermata. "The clinical response observed in our XYNGARI™ Phase 3 STAR-1 trial gives us confidence that XYNGARI™, if approved, could alter the current treatment paradigm in acne by providing patients with a novel, natural, once-weekly treatment option with minimal side effects and potentially quicker time to treatment effect."

Based on these results, Dermata plans to initiate the second XYNAGRI™ Phase 3 STAR-2 trial in the second half of 2025, which will be followed by an open-label extension study. If the STAR-2 study produces positive results, the Phase 3 program will help support the filing of a new drug application with the U.S. Food and Drug Administration.

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.

About Acne Vulgaris

Over 30 million acne patients in the U.S. seek treatment each year, with about 85% of U.S. teenagers experiencing some form of acne, and some individuals suffering from acne well into their 30s, 40s, and beyond. Acne is characterized by areas of scaly red skin, non-inflammatory blackheads and whiteheads, inflammatory papules and pustules, and occasionally cysts and scarring, which can present on the face, neck, chest, back, shoulders, and upper arms. While not life-threatening, acne can cause significant trauma for those suffering from it due to social stigmas, substantial risk of permanent facial scarring, lowered self-esteem, and social withdrawal.