Verrica Pharmaceuticals Amends Collaboration with Torii to Fund Phase 3 Trial of YCANTH® for Common Warts

May 15, 2024 – Verrica Pharmaceuticals Inc. (Nasdaq: VRCA), a company focused on dermatological therapeutics, has announced an amendment to its existing licensing agreement with Torii Pharmaceutical Co. Ltd. This amendment aims to initiate a global Phase 3 clinical trial of YCANTH® for treating common warts, starting in the first half of 2025. The collaboration will see the two companies sharing the cost and timeline benefits, with a minimal impact expected on Verrica’s cash reserves.

Common warts are a significant concern in medical dermatology, affecting around 22 million people in the U.S. Despite this, there are currently no FDA-approved treatments available. Verrica views this as a multibillion-dollar market opportunity, with a similar potential patient base in the European Union.

Verrica’s President and CEO, Ted White, expressed his enthusiasm about the partnership with Torii Pharmaceutical, highlighting their successful collaboration in developing YCANTH for molluscum contagiosum. The upcoming Phase 3 trial aims to address the treatment of common warts, the largest underserved patient group in dermatology. Positive results from this trial could lead to an sNDA submission in the U.S. for FDA approval and potential marketing authorizations in other regions, including the EU.

The initial agreement between Verrica and Torii in March 2021 granted Torii exclusive rights to develop and commercialize Verrica’s products for treating molluscum contagiosum and common warts in Japan. The new amendment stipulates that both companies will equally share the costs of the global Phase 3 trial. Torii will cover Verrica’s portion of the costs by offsetting their future payment obligations based on regulatory milestones and sales in Japan. Additionally, Torii will make an $8 million milestone payment to Verrica upon dosing the first patient in Japan for the Phase 3 trial. The commencement of the study is pending feedback from the U.S. FDA and Japan’s Pharmaceuticals and Medical Device Agency (PMDA) on the trial design.

In the U.S., common warts affect a substantial population, with about 50% of those seeking treatment being children. Verrica’s successful development and commercialization of YCANTH for common warts could create significant synergies with their current promotion of YCANTH for molluscum contagiosum, given the overlap in patient demographics.

Previously, Verrica announced encouraging outcomes from the Phase 2 COVE-1 clinical trial for YCANTH (VP-102) in common warts. Conducted in two cohorts, the trial assessed the safety and efficacy of VP-102 over 12 weeks, with primary analysis at Day 84 and follow-up through Day 147. Results showed a 51% complete clearance of warts in one cohort and a 51% reduction in wart count compared to baseline by Day 84.

YCANTH, formerly known as VP-102, is a proprietary drug-device combination for precise topical application of cantharidin, primarily for treating molluscum contagiosum. Approved by the FDA for use in patients aged two and older, YCANTH is designed for application by trained healthcare professionals. Verrica is also developing VP-102 to treat external genital warts and has another cantharidin-based candidate, VP-103, for plantar warts. Additionally, Verrica has a licensing agreement with Lytix Biopharma AS to develop VP-315 for non-melanoma skin cancers.

Common warts, caused by the human papilloma virus (HPV), are benign skin growths that can spread through touch. Treatment is recommended to prevent infection spread and alleviate discomfort.

Verrica Pharmaceuticals is dedicated to advancing dermatological therapeutics and holds the distinction of having the first FDA-approved treatment for molluscum contagiosum. They continue to develop treatments for other significant unmet needs in dermatology.

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