Dermata's XYNGARI Phase 3 Trial Hits Statistically Significant Difference At 4 Weeks

Benzinga·04/15/2025 12:42:06

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- 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

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