WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA) has completed enrollment in the first pivotal Phase 3 trial of YCANTH for common warts and passed an interim statistical review without a recommendation to add patients, keeping the company on track for its first topline results in the first quarter of 2027.
The West Chester-based drugmaker also reported that COVE-3, the second pivotal study in the global program, has surpassed 50% of its current enrollment target. Verrica currently expects topline results from that trial by mid-2027.
The clinical program is central to Verrica’s effort to broaden the commercial market for YCANTH, which is already approved in the U.S. and Japan for molluscum contagiosum. The company estimates common warts affect about 22 million people in the U.S., where there are currently no Food and Drug Administration-approved prescription drug therapies for the condition.
Verrica characterized the potential U.S. market as a multibillion-dollar opportunity. About half of patients seeking treatment for common warts in the U.S. are children, according to the company.
The COVE-2 interim analysis was conducted by an independent statistician to assess the trial’s statistical-power assumptions. Verrica and the study team remain blinded to the trial, and the review determined that no additional subjects were recommended.
COVE-2 and COVE-3 are double-blind, randomized, vehicle-controlled studies testing VP-102/TO-208 in patients ages 2 and older. Treatment is administered once every 21 days for as many as four applications.
COVE-2 enrolled patients exclusively in the U.S., while COVE-3 is enrolling participants in the U.S. and Japan. The broader Phase 3 program also includes a long-term follow-up study, COVE-4, and a pharmacokinetics study, COVE-5.
Chief Executive Officer Jayson Rieger said a successful label expansion would allow Verrica to use its existing commercial infrastructure for YCANTH rather than build a separate sales operation for common warts.
“The potential label expansion into common warts is a cornerstone of our long-term commercial strategy and could allow us to leverage our existing sales and marketing team,” Rieger said.
Verrica is conducting the program with Japan-based Torii Pharmaceutical Co. Ltd., a wholly owned subsidiary of Shionogi & Co. Ltd. If the Phase 3 studies are successful, Verrica intends to seek U.S. marketing approval while Torii plans to pursue approval in Japan.
The companies will split the global Phase 3 program’s costs on a 50-50 basis, with Torii funding the first $40 million of trial expenses. Verrica said that amount represents about 90% of the program’s current budget.
Verrica expects its share of those costs to be paid from future transfer-price payments, milestones and royalties tied to YCANTH sales in Japan.
The Phase 3 program follows the company’s COVE-1 Phase 2 study, which Verrica reported produced reductions in the number of common warts, complete clearance in some patients and durable clearance in many participants.
YCANTH is a drug-device combination containing a controlled formulation of cantharidin delivered through a single-use topical applicator. It is FDA-approved for healthcare professional-administered treatment of molluscum contagiosum in adults and children ages 2 and older.
The drug has also been approved for molluscum contagiosum in Japan following a separate Phase 3 trial involving about 300 patients. More information about the currently approved treatment is available at YCANTHPro.com.
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