- Dermata Therapeutics' (DRMA, Financial) Phase 3 trial shows early efficacy for its acne treatment, XYNGARI™.
- Statistically significant results achieved at week 4 after only four treatments.
- The once-weekly application could offer a more convenient option for patients.
Dermata Therapeutics (DRMA) has announced promising results from its Phase 3 STAR-1 trial for XYNGARI™, potentially the first once-weekly topical treatment for moderate-to-severe acne. Significantly, the trial demonstrated XYNGARI™'s efficacy after just four treatments by week 4, separating the treatment from placebo across all primary endpoints.
Key results include an Investigator Global Assessment (IGA) success rate of 11.9% for XYNGARI™ compared to 6.2% for placebo (p<0.05). Moreover, the mean reduction in inflammatory lesion count was -11.4 for XYNGARI™ versus -8.6 for placebo (p<0.001), while non-inflammatory lesion count saw a reduction of -12.4 against -8.8 for placebo (p<0.001).
The STAR-1 study involved 520 patients aged 9 and above, participating in a double-blind, placebo-controlled trial across the US and Latin America. This trial is critical as it marks the initial phase in a series of two pivotal Phase 3 studies, and the success in these trials could lead to an FDA new drug application submission.
Dermata's once-weekly application could significantly improve patient adherence, which is often a challenge with current acne treatments that require daily application. Success in the upcoming second Phase 3 trial will be a key step before submitting for FDA approval.
