Verrica Completes Enrollment in Phase 3 Trial of YCANTH for Common Warts

Verrica Pharmaceuticals has completed enrollment in COVE-2, the first pivotal Phase 3 trial in its global program evaluating YCANTH (VP-102) for the treatment of common warts. A per-protocol interim statistical power analysis confirmed that no additional patients are recommended for full enrollment, and the company expects topline data from COVE-2 in the first quarter of 2027. The second pivotal trial, COVE-3, has already exceeded 50% of its current target enrollment, with topline data currently expected by mid-2027.

“We have now completed enrollment in the first pivotal trial, COVE-2, after conducting a per-protocol interim analysis evaluating powering assumptions. The interim analysis confirms that no additional subjects are recommended,” said the company's president and chief executive officer. “We have also achieved greater than 50% of the current targeted enrollment in the second pivotal trial, COVE-3, ahead of schedule.” The chief medical officer added: “Patients often try minimally effective over-the-counter therapies, with limited success and frequent recurrence of warts. If the Phase 3 program is successful, YCANTH has the potential to become the first FDA-approved prescription drug treatment for common warts, one of the largest unmet needs in dermatology.”

The global Phase 3 program includes two double-blind, randomized, vehicle-controlled studies (COVE-2 and COVE-3) evaluating the efficacy and safety of VP-102/TO-208 when applied once every 21 days for a total of up to four applications in patients aged 2+ years with common warts. The interim analysis was done by an independent statistician, and the study remains fully blinded to the company and study team. COVE-2 enrolled patients in the U.S. only, while COVE-3 is enrolling patients in the U.S. and Japan. The program also includes a supportive long-term follow-up study (COVE-4) and a pharmacokinetics study (COVE-5).

Based on the results of the Phase 3 program, Verrica and its Japanese development partner, Torii Pharmaceutical Co. Ltd., a wholly-owned subsidiary of Shionogi & Co., Ltd., intend to seek marketing approval in the U.S. and Japan, respectively. Verrica has previously completed a Phase 2 study (COVE-1) that demonstrated clinically meaningful results, including a reduction in the number of common warts, patients with complete clearance of common warts, and durability of clearance in many patients.

Verrica and Torii will split the costs of the global Phase 3 program on a 50/50 basis, with Torii funding the first $40 million of trial costs, representing approximately 90% of the current trial budget. Verrica's portion of the costs is expected to be paid out of future transfer price payments, milestones, and royalties arising from sales of YCANTH in Japan.

With a prevalence of approximately 22 million patients in the U.S. alone and no FDA-approved prescription drug therapies, common warts represent one of the largest unmet needs in all of dermatology, which Verrica believes could represent a multibillion-dollar commercial opportunity. In the United States, approximately 50% of the patients who seek treatment for common warts are children.

YCANTH is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator. It is the first and only healthcare professional-administered product approved by the FDA to treat molluscum. Torii Pharmaceutical has confirmed the treatment launch of YCANTH for molluscum contagiosum in Japan.