WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA), a leading dermatology therapeutics provider, has shared promising top-line results from the Phase 3 trial of TO-208 for molluscum contagiosum (“molluscum”) treatment in Japan. The trial was conducted by Torii Pharmaceutical Co., Ltd., Verrica’s development and commercialization partner.
The double-blind, randomized, parallel-group comparison trial aimed to assess the efficacy and safety of TO-208, also known as VP-102 and marketed as YCANTH™ in the U.S. The drug was applied once every 21 days for up to four applications in patients suffering from molluscum.
According to the top-line results, the proportion of subjects achieving complete clearance of all treatable molluscum lesions at the end of the confirmatory study was statistically significant compared to placebo. This primary endpoint of efficacy indicates that TO-208 outperformed the placebo in treating molluscum. Furthermore, the drug was well tolerated during the study, underscoring its safety.
Ted White, Chief Executive Officer of Verrica Pharmaceuticals, expressed enthusiasm over the positive results. He highlighted that these findings underscore the consistent safety and efficacy of VP-102 and FDA-approved YCANTH™. White added, “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 entered an exclusive licensing agreement for the development and commercialization of VP-102 in Japan. Following the encouraging results from the Phase 3 trial and other ongoing studies, Torii plans to submit a manufacturing and marketing application for the product in Japan. This development marks a significant milestone in providing a viable treatment for molluscum, a common viral skin infection that currently lacks an FDA-approved treatment.
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