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Aclaris Therapeutics drug clears warts better than placebo in late-stage study

Aclaris Therapeutics Inc. said its treatment for common warts was more effective than placebo in a late-stage trial.

The Wayne, Pa.-based biopharmaceutical company's investigational new drug, A-101 45% topical solution, was evaluated in a phase 3 trial, dubbed Thwart-2 or Wart-302, against placebo, and achieved clinical and statistical significance in clearing common warts.

The treatment, a high concentration of hydrogen peroxide topical solution, met the main goal as well as all secondary efficacy goals of the study. A-101 45% topical solution is being developed as a potential prescription treatment for common warts.

Thwart-2, one of two late-stage trials evaluating A-101 45% topical solution as a potential treatment for common warts, enrolled 502 patients with one to six warts at the start of trial. Patients self-administered the medicine or placebo twice a week over a period of 8 weeks. A higher proportion of patients treated with Aclaris' therapy had all their identified common warts reported as clear 60 days after the start of treatment.

No serious side-effects related to the treatment were reported in patients who used the drug. The most common adverse effect, which occurred in over 5% of subjects, included pain at the application site, pallor and erythema, or skin redness, among others.

The company expects to report data from the second trial, named Thwart-1, or Wart-301, in the fourth quarter.

Currently, there are no FDA approved prescription treatments for common warts.

Aclaris Therapeutics stock price was up 50% to $1.65 as of 6:03 p.m. ET on Sept. 16.