A-101 45% (Aclaris Therapeutics) met the primary and all secondary efficacy endpoints, according to the company.
A-101 45% (Aclaris Therapeutics) met the primary and all secondary efficacy endpoints, according to the company. Positive results have been shown for the topical treatment of verruca vulgaris based on data from a second Phase 3 clinical trial, THWART-1 (WART-301).
The drug is a proprietary, high-concentration hydrogen peroxide topical solution intended for the treatment of common warts. A-101 was tested for safety and efficacy through two randomized, double-blind trials compared to placebo. 503 participants self-administered either A-101 45% or placebo twice a week over a course of 8 weeks.
The primary endpoint was met with statistical significance, with subjects treated with A-101 45% reporting their warts as “clear” at day 60. Warts were assessed using the Physician Wart Assessment™ scale.
All secondary efficacy endpoints also achieved statistical significance. The most common adverse events (AEs) occurring in more than 5% of subjects in the A-101 45% group were application site pain, scabbing, erythema, pruritus and erosion. AEs were reported in 52.8% and 6% of the subjects in the A-101 45% and vehicle groups.
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) [news release]. Wayne, PA; Aclaris Therapeutics, Inc: October 24, 2019. https://investor.aclaristx.com/news-releases/news-release-details/aclaris-therapeutics-101-45-topical-solution-meets-primary-and-1. Accessed October 28, 2019.