Aclaris Therapeutics Inc. said its common warts' treatment, A-101 45% topical solution, was more effective than placebo in a second late-stage trial.
The Wayne, Pa.-based biopharmaceutical company's drug candidate was evaluated in a phase 3 trial, called THWART-1 and WART-301, against placebo, and achieved clinical and statistical significance in removing common warts.
A-101 45% topical solution, a high concentration hydrogen peroxide solution, met the main goal as well as all secondary efficacy goals of the study, the company said.
THWART-1 was the second late-stage study which evaluated A-101 45% topical solution to treat common warts. The previous phase 3 study, dubbed THWART-2, also achieved clinical and statistical significance in clearing common warts.
THWART-1 enrolled 503 patients with up to six warts at the start of the trial who self-administered the medicine or placebo twice a week for over a period of eight weeks. A higher proportion of patients who were treated with the medicine reported their warts had cleared by day 60.
No serious side-effects related to the treatment were reported.
Aclaris said the results from the studies will serve as a basis for a New Drug Application filing and will interest partners in seeking to commercialize the drug.
There are no FDA approved prescription treatments for common warts.