Aclaris Therapeutics, Inc.’s lead drug candidate A-10 demonstrated clinically and statistically significant improvements in removing seborrheic keratosis (SK) lesions on the face in its third Phase II clinical trial. The double-blind, vehicle-controlled Phase 2 clinical trial was designed to evaluate the safety, tolerability, and effectiveness of A-101 in removing targeted SK lesions on the face. The trial used a parallel-group design to compare two concentrations of A-101 and vehicle (placebo) in 120 subjects with SK lesions on the face. Results from the trial showed A-101 achieved statistical significance in clearing SK lesions in a dose-related fashion. A-101 was well tolerated at both concentrations studied.

“This outcome represents another important milestone for A-101 and, along with results from prior Phase 2 studies, lays the groundwork for discussions with the FDA about next steps,” said Stuart D. Shanler, MD, Chief Scientific Officer of Aclaris Therapeutics. “We look forward to moving A-101 into Phase 3 development and are encouraged about its potential as a non-invasive treatment for SK, a condition for which there are currently no FDA-approved drug therapies.”

“Results from the three Phase II clinical trials suggest that A-101 has the potential to be an effective option to treat SK lesions,” said Jonathan S. Weiss, MD, Assistant Clinical Professor of Dermatology at Emory University School of Medicine and private practitioner in Snellville, GA. “A well-tolerated, FDA-approved, non-invasive treatment for SK would be a welcome advance for patients and physicians.”