Dermata Therapeutics, Inc. (NASDAQ: DRMA) has seen a sharp gain in share price; the company is currently trading at $2.18, indicating a stunning 61.48% increase in pre-market activity. This spike comes after the company’s major Phase 3 clinical trial released encouraging early findings.
Breakthrough Findings from the XYNGARI Trial
The first Phase 3 study of Dermata Therapeutics’ once-weekly topical therapy XYNGARI, which treats moderate-to-severe acne, showed promising topline results. The findings indicated that XYNGARI had a good safety profile in addition to exhibiting excellent effectiveness. Patients responded favorably to the medication, with few adverse events and no significant side effects.
After just 12 weeks of therapy, the Phase 3 Spongilla therapy for Acne Research (STAR-1) study demonstrated a statistically significant improvement when compared to a placebo, meeting all three of the main objectives. This result highlights XYNGARI’s potential as a successful acne therapy.
Overcoming Obstacles in Patient Compliance
The creation of XYNGARI represents a major breakthrough in acne therapy, especially considering that it is used once a week. The weekly schedule of XYNGARI may improve patient adherence in contrast to current FDA-approved topical acne therapies, which call for daily or twice-day administrations. By tackling patient compliance, a key obstacle to successful acne control, this invention may enhance overall treatment results.
Strategies for Upcoming Research and Regulatory Submission
Dermata Therapeutics is proceeding with planning for the Phase 3 STAR-2 study, which is scheduled to start in the second half of 2025, after receiving encouraging findings from the Phase 3 trial. A New Drug Application (NDA) filing to the U.S. Food and Drug Administration (FDA) is anticipated to be supported by further data from the STAR-2 trial and an open-label extension study.
Additionally, DRMA is negotiating with possible partners for XYNGARI’s future cooperation and commercialization. Dermata Therapeutics (DRMA) is establishing XYNGARI as a potential addition to the acne treatment market with these ground-breaking findings, providing patients with a new, practical, and efficient choice.