Verrica Pharmaceuticals Inc. announced the first U.S. patient was dosed in the COVE-3 trial, the second pivotal study in its global Phase 3 program evaluating YCANTH (VP-102) for the treatment of common warts. The company's development partner, Torii Pharmaceutical Co. Ltd., a wholly-owned subsidiary of Shionogi & Co. Ltd., also dosed the first Japanese patient in the COVE-3 study last week. The initiation of this trial marks a significant step toward addressing a large unmet medical need, with an estimated 22 million people in the U.S. impacted by common warts annually.

The Phase 3 program comprises two double-blind, randomized, vehicle-controlled studies designed to evaluate the efficacy and safety of VP-102/TO-208. The treatment regimen involves application once every 21 days for up to four applications in patients aged two years and older. The COVE-2 study is enrolling patients in the U.S. only, while the COVE-3 study includes enrollment sites in both the U.S. and Japan. Based on the results, Verrica and Torii intend to seek marketing approval in the U.S. and Japan, respectively.

Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica, highlighted the progress of the program. He noted that the company has achieved over 50% of the current targeted enrollment in the COVE-2 trial in the U.S. and is also enrolling patients in the long-term follow-up study, COVE-4. The advancement of YCANTH into both planned pivotal Phase 3 studies reflects the companies' commitment to developing a potential first-approved therapy for common warts in the U.S.

The clinical development is supported by data from the Phase 2 COVE-1 trial. In that open-label study, 51% of subjects (18 of 35) in Cohort 2 achieved complete clearance of all treatable warts at Day 84. Adverse events were primarily expected local cutaneous reactions, with no serious adverse events observed. The primary efficacy analysis was conducted at Day 84, with follow-up through Day 147.

Torii will split the costs of the global Phase 3 program with Verrica on a 50/50 basis. Torii will fund the first $40 million of trial costs, representing approximately 90% of the current trial budget. Verrica's portion is expected to be paid out of future milestones and royalties arising from sales of YCANTH in Japan. Verrica maintains ownership of global rights to YCANTH for all indications in all territories outside of Japan.

Phase 3 Program Overview

YCANTH is a proprietary drug-device combination product containing a GMP-controlled formulation of cantharidin. It is currently approved by the FDA for the treatment of molluscum contagiosum in adult and pediatric patients two years of age and older. The product is also approved for molluscum contagiosum in Japan. Approximately 250 million lives are eligible to receive YCANTH covered by insurance.