Once-Weekly Topical Acne Treatment Shows Positive Results in Phase 3 Trial
Xyngari resulted in significant improvements in IGA treatment success, inflammatory lesion count, and non-inflammatory lesion count compared to placebo.
Positive results have been announced from a phase 3 trial evaluating the efficacy, safety, and tolerability of Xyngari for the treatment of moderate to severe facial acne in patients aged 9 years or older, Dermata Therapeutics announced in a release.1 The results make Xyngari the first once-weekly topical product to demonstrate clinical benefit in a phase 3 study for the condition, the company said.
Once-Weekly Topical Acne Treatment Shows Positive Results in Phase 3 Trial / frank29052515 - stock.adobe.com
Topline results from the STAR-1 trial (NCT06090721) showed that Xyngari met all 3 of its primary endpoints, including the mean change in inflammatory and noninflammatory lesion counts and the Investigator Global Assessment (IGA) treatment response. The therapy was also seen to be safe and well tolerated by patients.
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"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, MD, FAAD, FACP, clinical investigator at the Center for Dermatology Clinical Research, said in a release.1 "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."
STAR-1 is a randomized, double-blind, placebo-controlled trial evaluating the tolerability, safety, and efficacy of Xyngari topical powder mixed with diluent in patients aged 9 years or older with moderate to severe facial acne. The study cohort includes 520 patients with a clinical diagnosis of moderate to severe acne vulgaris. Patients were excluded if they were pregnant or planning to become pregnant, or were already using a topical therapy on the face.
Patients randomly received either the therapy or a placebo once a week for 12 weeks and were evaluated monthly. The study found there were significant differences in IGA treatment success, inflammatory lesion count, and non-inflammatory lesion count between Xyngari and placebo at 12 weeks. Of 342 patients who received the therapy, 29.4% achieved a 2-point reduction and a score of clear or almost clear on the IGA, compared to 15.2% of 178 patients in the placebo group.
The mean change from baseline in inflammatory lesion count was -16.8 for the Xyngari group, compared to -13.1 in the placebo group. The mean change from baseline in noninflammatory lesion count was -17.3 in the Xyngari group, compared to -12.4 for placebo. Additionally, there were minimal treatment related adverse events and no serious adverse events attributed to the therapy.
Dermata said in the release that it plans to initiate a second phase 3 trial, STAR-2, in the second half of 2025. That trial will be followed by an open-label extension study. If STAR-2 shows similar positive results as STAR-1, the company said it will aid in the filing of a new drug application with the FDA.
"We wish to thank the study subjects and investigators for their participation in our study, as we could not have had this success without them," Christopher Mardo, PhD, chief development officer of Dermata, said in a release.1 "The clinical response observed in our Xyngari phase 3 STAR-1 trial gives us confidence that Xyngari, if approved, could alter the current treatment paradigm in acne by providing patients with a novel, natural, once-weekly treatment option with minimal side effects and potentially quicker time to treatment effect."
READ MORE: Dermatology Resource Center
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