Aclaris Therapeutics A-101 45% met primary, all secondary endpoints in 2 trials
Aclaris Therapeutics announced positive results from its two Phase 2 clinical trials, WART-202 and WART-203, of A-101 45% topical solution, referred to as A-101 45%, an investigational new drug for the treatment of common warts. A-101 45% met all primary and secondary endpoints of each trial, achieving clinically and statistically significant clearance of common warts. A-101 45% is a proprietary high-concentration hydrogen peroxide topical solution being developed as a prescription treatment for common warts. Both trials evaluated the safety and efficacy of A-101 45% as compared to placebo. The two randomized, double-blind, vehicle-controlled trials were designed to understand the effects of dose frequency and to explore additional clinical endpoints that will be further evaluated in a planned Phase 3 development program. The WART-203 trial evaluated 159 patients who self-administered either A-101 45% or placebo twice weekly through Day 56, for a total of 16 treatments. Each patient had between one and six warts at baseline. The trial achieved its primary endpoint, which was mean change from baseline in the Physician's Wart Assessment, or PWA, scale score at Day 56 (Visit 10 or one week after the last treatment). The PWA score is a four-point scale of the investigators' assessment of the severity of a target wart at a particular time point.