Torii Pharmaceutical reports ‘positive’ results from Phase 3 trial of TO-208

Verrica Pharmaceuticals announced that its development and commercialization partner, Torii Pharmaceutical Co., reported positive top-line results from its Phase 3 trial of TO-208 for the treatment of Molluscum Contagiosum in Japan. The Phase 3 trial was conducted in Japan and is a double blind, randomized and parallel-group comparison study to evaluate the efficacy and safety of TO-208 in comparison to placebo, when applied once every 21 days for up to four applications in patients with molluscum. The top-line results show that the proportion of subjects achieving complete clearance of all treatable molluscum lesions at the completion of the confirmatory study, the primary endpoint of efficacy, was statistically significant versus placebo. TO-208 was well tolerated during the study. “We are obviously excited by the positive results from this confirmatory Phase 3 trial for TO-208 for the treatment of molluscum in Japan, which underscores the consistent safety and efficacy of VP-102 and FDA-approved YCANTH,” said Ted White, CEO of Verrica Pharmaceuticals. “We believe Torii is an ideal partner to bring the product to people with molluscum in Japan, and these positive results take us one step closer towards achieving our goal of addressing this large and underserved patient population.” In March 2021, Verrica and Torii signed an exclusive licensing agreement for the development and commercialization of VP-102 in Japan. Torii intends to submit a manufacturing and marketing application for the product in Japan, based on the results of the Phase 3 trial and other studies currently being conducted.