Promising SK drug’s trials enter final phases

Results from a phase 2b clinical trial suggest that the Aclaris Therapeutics drug A-101 performed well in clearing multiple seborrheic keratoses (SK) lesions.

The double-blind trial was designed to evaluate the safety, tolerability and efficacy of A-101 in removing SK lesions on the trunk and extremities. The trial compared two concentrations of A-101 and placebo in 172 subjects with SK lesions. Results from the study show that A-101 achieved statistical significance in clearing SK lesions.

“At our site, the drug was well tolerated, with most subjects reporting no more than mild burning and stinging during the application process,” trial investigator Janet DuBois, M.D., an Austin, Texas, dermatologist, tells Dermatology Times. “Most subjects were pleased with the procedure and their outcomes.”

According to the company, these findings, along with results from a second phase 2b study to evaluate A-101 in treating facial SK lesions, will help support the progression of A-101 into phase 3 trials. Results from the second phase 2b study are a few weeks away.

“We are on target with our clinical development plan, which supports filing [a Food and Drug Administration New Drug Application] in 2016,” Aclaris President and C.E.O. Neal Walker, M.D., tells Dermatology Times.

Dr. Walker notes that no FDA-approved SK therapies are currently available.