Verrica Pharmaceuticals Inc. 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 (cantharidin) for the treatment of common warts.
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.
The trial is expected to begin in the first half of 2025.
“Torii has been an outstanding partner in the development of YCANTH for molluscum contagiosum, and we look forward to our continued collaboration to progress YCANTH through a pivotal global Phase 3 clinical trial for common warts, which represents the single largest and most underserved patient population in all of dermatology,” says Ted White, President and Chief Executive Officer of Verrica Pharmaceuticals, in a news release. “If positive, the data from this global Phase 3 clinical trial would not only potentially allow Verrica to submit a supplemental new drug application (sNDA) in the U.S. seeking Food and Drug Administration approval for the use of YCANTH for the treatment of common warts, but may also be utilized by Verrica to seek future marketing authorizations in territories outside the U.S. and Japan, including potentially within the European Union.”
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.
COVE-1 Phase 2 Data in Common Warts
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.
About YCANTH (formerly VP-102)
YCANTH (cantharidin) topical solution, 0.7% is currently approved by the FDA to treat molluscum in adult and pediatric patients 2 years of age and older. In addition, Verrica has successfully completed a Phase 2 clinical trial of VP-102 for the treatment of common warts and a Phase 2 clinical trial of VP-102 for the treatment of external genital warts.
