Aclaris Therapeutics’ A-101 45% Topical Solution Meets Primary and All Secondary Efficacy Endpoints in Pivotal Phase 3 Trial for the Treatment of Common Warts (THWART-2)

• Highly statistically significant results at the primary endpoint - statistical significance seen as early as Day 29
• Highly statistically significant results on all secondary efficacy endpoints
• WART-302 is the first of two Phase 3 pivotal trials for the NDA
• If approved, A-101 45% Topical Solution would be the first FDA approved prescription treatment for common warts

WAYNE, Pa., Sept. 16, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, today announced positive results from its Phase 3 clinical trial, THWART-2 (WART-302), of A-101 45% Topical Solution (A-101 45% Topical Solution), an investigational new drug for the treatment of common warts (verruca vulgaris). A-101 45% Topical Solution met the primary and all secondary efficacy endpoints, achieving clinically and statistically significant clearance of common warts. A-101 45% Topical Solution is a proprietary high-concentration hydrogen peroxide topical solution being developed as a potential prescription treatment for common warts. 

THWART-2 is one of two randomized double-blind vehicle-controlled Phase 3 pivotal trials conducted by Aclaris to evaluate A-101 45% Topical Solution as a potential treatment for common warts. Aclaris expects to report data from THWART-1 (WART-301), the second Phase 3 trial during the fourth quarter of 2019. Both trials evaluated the efficacy and safety of A-101 45% Topical Solution as compared to placebo (vehicle). The two randomized, double-blind, vehicle-controlled trials were designed to demonstrate the efficacy and safety of A-101 45% Topical Solution for the potential treatment of common warts when applied by subjects (or the parents/guardians of subjects < 18 years).

In the THWART-2 trial, 502 subjects who had one to six warts at baseline were randomized and self-administered either A-101 45% Topical Solution or vehicle twice a week over 8 weeks, for a total of 16 treatments. The trial achieved its primary endpoint with a high degree of statistical significance (p