Verrica Pharmaceuticals Inc. announced that it has entered into an amendment to its existing licensing agreement with Torii Pharmaceutical Co. Ltd. (Torii), to jointly conduct a global pivotal Phase 3 clinical trial of YCANTH®? for the treatment of common warts.

In March 2021, Verrica and Torii Pharmaceutical entered into an agreement granting Torii an exclusive license to develop and commercialize Verrica?s product candidates for the treatment of molluscum contagiosum and common warts in Japan, including YCANTH (TO-208 in Japan). The terms of the amendment would enable the two parties to equally split the cost of the global Phase 3 clinical trial in common warts, with Torii funding Verrica?s portion of the costs as an offset to Torii?s future payment obligations to Verrica based on regulatory milestones and sales of YCANTH for molluscum contagiosum and common warts in Japan. In addition, Torii would make a milestone payment of $8 million to Verrica upon the first patient dosed in Japan in the Phase 3 clinical trial.

Initiation of the global study remains subject to feedback from the U.S. FDA and Japan?s Pharmaceuticals and Medical Device Agency (PMDA) on the proposed design of the Phase 3 clinical trial. With a prevalence of approximately 22 million patients in the U.S. alone and no FDA approved therapies, common warts represent one of the largest unmet needs in all of dermatology, which Verrica believes represents a multibillion-dollar commercial opportunity. In the United States, approximately 50% of the patients who seek treatment for common warts are children.

If YCANTH is successfully developed, approved and commercialized for the treatment of common warts, Verrica anticipates a high degree of call point overlap and marketing synergies with its molluscum promotion of YCANTH. Verrica further believes that the common wart patient opportunity in the European Union is at least as large as that in the United States. Verrica has previously announced positive results from the Phase 2 COVE-1 clinical trial that evaluated YCANTH (VP-102) for the treatment of common warts.

COVE-1 was an open label clinical trial that evaluated the safety and efficacy of VP-102 in two cohorts of subjects with up to six warts. The primary analysis was conducted at Day 84 with an additional period of follow-up through Day 147. Topline analysis included data from the assessment of warts at study visits over 12 weeks.

Results showed that 51% of subjects (18 of 35) treated with VP-102 in Cohort 2 achieved complete clearance of all treatable warts at Day 84. Secondary endpoints included the percent change from baseline in the number of treatable warts and VP-102 achieved a 51% reduction in the number of warts (28 of 55 warts) compared to baseline by Day 84.