Topical solution from Aclaris clears warts by day 29 in phase 3 study
Aclaris Therapeutics announced positive results from a phase 3 clinical trial of A-101 45% topical solution, an investigational new drug for the treatment of common warts.
The study, THWART-2, met primary and secondary endpoints, with the topical solution achieving clinically and statistically significant clearance of common warts as early as day 29, according to a press release.
A-101 45% topical solution is a proprietary high-concentration hydrogen peroxide topical treatment being developed as a potential prescription treatment for common warts.
Data from THWART-1, the second phase 3 trial, are expected later this year.
Each trial was randomized, double-blind and vehicle-controlled to evaluate the efficacy and safety of A-101 45% topical solution compared with placebo.
A total of 502 participants with one to six warts at baseline took part in THWART-2 and were randomly assigned to self-administer A-101 45% topical solution or vehicle twice a week for 8 weeks, for a total of 16 treatments.
The trial achieved its primary endpoint in the treatment group: all identified common warts were reported as clear at day 60 (P < .0001), using the Physician Wart Assessment scale.
Additionally, complete clearance was reported in all warts at day 137 (P = .0001) with the treatment solution. Mean per participant percent of treated warts at day 137 and time to complete clearance of all warts were also superior in the A-101 45% topical solution group (P < .0001).
There were no treatment-related serious adverse events in those treated with A-101 45% topical solution, but treatment-related application site adverse events were reported in 53.4%.