Dermata Therapeutics Inc.
09/17/2025 | Press release | Distributed by Public on 09/17/2025 04:05
Material Event (Form 8-K)
Item 8.01 Other Events.
On September 17, 2025, Dermata Therapeutics, Inc. (the "Company") issued a press release disclosing the Company's presentation of an abstract at the European Academy of Dermatology and Venereology Congress 2025. The abstract contains clinical data from the Company's XYNGARI™ (also known as DMT310) Phase 3 Spongilla Treatment of Acne (STAR-1) clinical trial.
In an intent to treat analysis, the Company saw statistically significant differences in IGA treatment success, mean change in inflammatory lesion count, and non-inflammatory lesion count and percent change in inflammatory lesion count, and non-inflammatory lesion count at week 4, 8, and 12 when compared to placebo.
Investigator Global Assessment (IGA): Patients achieving a 2-point reduction AND score of 0 or 1 ("clear" or "almost clear")
| Week 4 | Week 8 | Week 12 | ||||||||||
| XYNGARI™ (n=342) | 11.9 | % | 21.6 | % | 29.4 | % | ||||||
| Placebo (n=178) | 6.2 | % | 8.0 | % | 15.2 | % | ||||||
| p-value | P < 0.05 | P < 0.001 | P < 0.001 | |||||||||
Investigator Global Assessment (IGA): Patients achieving a 2-point reduction
| Week 4 | Week 8 | Week 12 | ||||||||||
| XYNGARI™ (n=342) | 14.3 | % | 26.2 | % | 34.3 | % | ||||||
| Placebo (n=178) | 8.4 | % | 10.2 | % | 20.1 | % | ||||||
| p-value | P < 0.05 | P < 0.001 | P < 0.001 | |||||||||
Mean change from baseline in inflammatory lesion count
| Week 4 | Week 8 | Week 12 | ||||||||||
| XYNGARI™ (n=342) | -11.4 | -14.7 | -16.8 | |||||||||
| Placebo (n=178) | -8.6 | -10.9 | -13.1 | |||||||||
| p-value | P < 0.001 | P < 0.001 | P < 0.001 | |||||||||
Percent change from baseline in inflammatory lesion count
| Week 4 | Week 8 | Week 12 | ||||||||||
| XYNGARI™ (n=342) | 41.3 | % | 52.4 | % | 59.1 | % | ||||||
| Placebo (n=178) | 29.5 | % | 37 | % | 45.3 | % | ||||||
| p-value | P < 0.001 | P < 0.001 | P < 0.001 | |||||||||
Mean change from baseline in non-inflammatory lesion count
| Week 4 | Week 8 | Week 12 | ||||||||||
| XYNGARI™ (n=342) | -12.4 | -15.0 | -17.3 | |||||||||
| Placebo (n=178) | -8.8 | -10.4 | -12.4 | |||||||||
| p-value | P < 0.001 | P < 0.001 | P < 0.001 | |||||||||
Percent change from baseline in non-inflammatory lesion count
| Week 4 | Week 8 | Week 12 | ||||||||||
| XYNGARI™ (n=342) | 35.3 | % | 42.5 | % | 48.3 | % | ||||||
| Placebo (n=178) | 25.7 | % | 30.0 | % | 34.7 | % | ||||||
| p-value | P < 0.001 | P < 0.001 | P < 0.001 | |||||||||
Dermata Therapeutics Inc. published this content on September 17, 2025, and is solely responsible for the information contained herein. Distributed via SEC EDGAR on September 17, 2025 at 10:05 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]