Dermata Therapeutics Inc (DRMA)

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Dermata’s XYNGARI(TM) Phase 3 Trial Hits Statistically Significant Difference at 4 Weeks
- Dermata previously announced XYNGARI(TM) produced highly statistically significant topline data for all primary endpoints at week 12 in Phase 3 trial -

- Additional data analysis revealed that XYNGARI(TM) separated from placebo after just four once-weekly treatments -

- XYNGARI(TM) could be the first once-weekly topical product candidate for moderate-to-severe acne -

SAN DIEGO, CA / ACCESS Newswire / April 15, 2025 / Dermata Therapeutics, Inc. (Nasdaq:DRMA)(Nasdaq:DRMAW) ("Dermata" or the "Company"), a late-stage biotechnology company focusing on the treatment of medical skin diseases and aesthetic applications, today announced that additional analysis of topline data from its Phase 3 STAR-1 trial showed that XYNGARI™ had a statistically significant difference from placebo on three efficacy endpoints as early as week 4, which occurred after just four treatments with XYNGARI™.

XYNGARI™ Phase 3 STAR-1 Topline Week 4 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 4 (earliest measured timepoint) when compared to placebo.

Investigator Global Assessment: Patients achieving a 2-point reduction AND score of 0 or 1 ("clear" or "almost clear")


Week 4

XYNGARI™ (n=342)

11.9%

Placebo (n=178)

6.2%

p-value

p < 0.05

Mean change from baseline in inflammatory lesion count


Week 4

XYNGARI™ (n=342)

-11.4

Placebo (n=178)

-8.6

p-value

p < 0.001

Mean change from baseline in non-inflammatory lesion count


Week 4

XYNGARI™ (n=342)

-12.4

Placebo (n=178)

-8.8

p-value

p < 0.001

"We are very excited to see such great separation from placebo as early as week 4, after just four once-weekly treatments, which we believe shows how quickly XYNGARI™ can work for some patients," commented Christopher Nardo, Ph.D., Chief Development Officer of Dermata. "We believe acne patients are looking for a product that can reduce their inflammatory lesions as quickly as possible, which reduces the appearance of acne, and we think XYNGARI's™ early efficacy could be a strong driver of patient compliance. We expect these data, coupled with the fact that XYNGARI™ only needs to be applied once per week, will help differentiate XYNGARI™ from other products currently on the market," concluded Dr. Nardo.

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 12 week 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.

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 includemechanical components and chemical compounds to help treat inflammatory skin diseases, like acne. After processing,