WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA) announced that its partner, Torii Pharmaceutical Co. Ltd., has submitted a New Drug Application (NDA) in Japan for TO-208, a cantharidin-based treatment for Molluscum Contagiosum. Known as YCANTH® in the United States, TO-208 could become the first approved treatment for molluscum in Japan, addressing a significant unmet medical need.
Molluscum contagiosum is a highly contagious skin condition that affects an estimated 1.6 million people in Japan, primarily children. If approved, TO-208 could provide a new therapeutic option for this underserved patient population.
Jayson Rieger, Ph.D., MBA, President and CEO of Verrica Pharmaceuticals, emphasized the importance of the milestone. “Torii continues to be an outstanding partner in advancing TO-208 for the treatment of molluscum, and today’s NDA submission represents the next critical milestone towards bringing to market the first therapeutic for addressing this indication in Japan,” Rieger said.
Clinical trials for TO-208 in Japan have shown promising results. The Phase 3 study successfully met its primary endpoint, demonstrating the drug’s efficacy compared to a vehicle treatment. Additionally, the safety profile of TO-208 was consistent with previous trials conducted in the U.S., with no significant tolerability issues reported.
The submission is part of an exclusive license agreement between Verrica and Torii, signed in March 2021, to develop and commercialize TO-208 for molluscum and common warts in Japan. Verrica has already received U.S. FDA approval for YCANTH® to treat molluscum contagiosum in patients aged two and older, launching the product domestically in August 2023.
YCANTH® is a proprietary drug-device combination containing a precisely dosed formulation of cantharidin for topical application by healthcare professionals. Its approval in the U.S. was based on two successful Phase 3 clinical trials involving approximately 500 patients, establishing it as a safe and effective treatment.
With this NDA submission, Torii and Verrica aim to expand the availability of TO-208 globally, addressing a significant gap in treatment for millions affected by molluscum contagiosum.
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