Aclaris Therapeutics’ A-101 45% Topical Solution Meets Primary and All Secondary Efficacy Endpoints in Second Successful Pivotal Phase 3 Clinical Trial for the Treatment of Common Warts (THWART-1)

If approved, A-101 45% Topical Solution would be the first FDA-approved prescription treatment for common warts

• Highly statistically significant results for the primary efficacy endpoint
• Highly statistically significant results for all secondary efficacy endpoints
• Management to host conference call at 4:30 PM ET today

WAYNE, Pa., Oct. 24, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced positive results from its second Phase 3 clinical trial, THWART-1 (WART-301), of A-101 45% Topical Solution (A-101 45%), an investigational new drug, for the potential treatment of common warts (verruca vulgaris). A-101 45% met the primary and all secondary efficacy endpoints, achieving clinically meaningful and statistically significant clearance of common warts. A-101 45% is a proprietary high-concentration hydrogen peroxide topical solution being developed as a potential prescription treatment for common warts. 

THWART-1 is the second of two Phase 3 pivotal trials: THWART-1 and THWART-2 (WART-301 and WART-302, respectively) conducted by Aclaris.  The two randomized, double-blind, vehicle-controlled trials were designed to evaluate the efficacy and safety of A-101 45% as compared to placebo (vehicle) for the treatment of common warts when applied by subjects (or the parents/guardians of subjects < 18 years).

The THWART-1 trial randomized 503 subjects who self-administered either A-101 45% or vehicle twice a week over 8 weeks, for a total of 16 treatments. Each subject had one to six common warts at baseline. The trial achieved its primary endpoint with a high degree of statistical significance (p=0.0003), i.e. a higher proportion of subjects treated with A-101 45% versus vehicle had all their identified common warts reported as clear at day 60.  Warts were assessed using the Physician Wart Assessment™ scale which is a validated four-point scale of the investigators’ assessment of the severity of all treated common warts (PWA=0 means clear).  All secondary efficacy endpoints also achieved statistical significance in favor of A-101 45% versus vehicle.

Efficacy results from the THWART-1 and THWART-2 trials for the primary and first two secondary endpoints are summarized in the table below: