Verrica Pharmaceuticals Inc., specializing in dermatology therapeutics, has announced a significant update to its licensing agreement with Torii Pharmaceutical Co. Ltd. This involves collaborating on a global pivotal Phase 3 clinical trial of YCANTH® for common warts treatment.

Verrica Pharmaceuticals, expressed satisfaction with the collaboration, particularly Torii's role in YCANTH's development for molluscum contagiosum. The Phase 3 trial for common warts is a notable advancement, aiming to address a significant and underserved patient population. Success in this trial could lead to FDA submission for YCANTH's use in treating common warts in the U.S. and potential market entry in other territories, including the EU.

Under the amendment, both parties will equally share the costs of the global Phase 3 trial. Torii will fund Verrica's expenses, offsetting future payment obligations based on regulatory milestones and YCANTH sales in Japan. Additionally, Torii will make an $8 million milestone payment upon the first patient dosed in Japan for the Phase 3 trial. However, the trial's initiation depends on feedback from the U.S. FDA and Japan’s Pharmaceuticals and Medical Device Agency (PMDA) regarding its design.

Common warts affect roughly 22 million individuals in the U.S. with no FDA-approved therapies, posing a significant unmet medical need, especially for children, who comprise about 50% of those seeking treatment. Verrica foresees substantial commercial opportunities, estimating the market size to be multibillion-dollar if YCANTH gains approval for treating common warts.

Previously, Verrica reported positive results from the Phase 2 COVE-1 clinical trial evaluating YCANTH (VP-102) for common warts. The trial demonstrated promising efficacy with 51% of subjects achieving complete wart clearance by Day 84.

YCANTH is a proprietary drug-device combination product, comprising a GMP-controlled formulation of cantharidin delivered via a single-use applicator for precise topical dosing. FDA approval has already been granted for YCANTH to treat molluscum in both adult and pediatric patients aged 2 years and older. Notably, YCANTH should only be administered by trained healthcare professionals and is not intended for home use.

 

Source: globenewswire.com

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