Nano-Cap Dermata Therapeutics Unveils Positive Data From Once Weekly Drug Study For Acne
Dermata Therapeutics, Inc. (NASDAQ:DRMA) stock is trading higher on Thursday.
The company, which focuses on skin diseases and aesthetic applications, released topline results from its first pivotal STAR-1 Phase 3 trial of Xyngari.
The novel, once-weekly, topical product candidate for moderate-to-severe acne also appeared to be safe and well-tolerated by patients.
Trial participants reported minimal treatment-related adverse events and no serious adverse events.
On Thursday, the company said the trial met all three primary endpoints. It achieved a statistically significant difference compared with a placebo after 12 weeks of once-weekly treatments with Xyngari.
“I believe having a once-weekly topical product with a strong efficacy and safety profile, like Xyngari, would be a great addition to a dermatologist’s arsenal for treating acne,” Sunil Dhawan, clinical investigator, said. “All FDA-approved topical acne products are required to be applied at least once or twice a day, which may reduce patient compliance, so I believe having a once-weekly topical acne product like Xyngari could lead to improved patient compliance.”
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) (29.4% vs. 15.2%).
In the intent-to-treat analysis, Dermata saw statistically significant differences in IGA treatment success, inflammatory lesion count (-16.8 vs. -13.1), and noninflammatory lesion count (-17.3 vs. -12.4) at Week 12 (study end) compared to placebo.
Dermata plans to initiate the second Xyngari Phase 3 STAR-2 trial in the second half of 2025. An open-label extension study will follow.
Price Action: DRMA stock is up 48.1% at $2 during the premarket session at the last check Thursday.
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