Verrica Completes COVE-2 Enrollment for YCANTH

Enrollment closure in COVE-2 positions Verrica Pharmaceuticals to deliver topline data from its first pivotal Phase 3 trial by Q1 2027, a timeline that now anchors the company's regulatory submission strategy for a common warts label expansion of YCANTH (VP-102). A per-protocol interim statistical power analysis, conducted by an independent statistician with the study remaining fully blinded, confirmed no additional subjects are required to meet enrollment targets.

The COVE-2 study enrolled patients exclusively in the U.S. and follows a double-blind, randomized, vehicle-controlled design evaluating VP-102 applied once every 21 days for up to four applications in patients aged two years and older. A parallel pivotal trial, COVE-3, which enrolls patients in both the U.S. and Japan, has already exceeded 50% of its current target enrollment ahead of schedule, with topline data expected by mid-2027. Verrica's Japanese development partner, Torii Pharmaceutical Co. Ltd., a wholly-owned subsidiary of Shionogi, is co-funding the global program on a 50/50 cost-share basis, with Torii funding the first $40 million of trial costs.

The regulatory context is material for development operations teams. If the Phase 3 program supports an FDA submission, YCANTH would be positioned as the first FDA-approved prescription treatment for common warts, an indication currently addressed only by over-the-counter therapies with documented recurrence limitations. The program's supporting architecture includes a long-term follow-up study (COVE-4) and a pharmacokinetics study (COVE-5), both of which will contribute to the evidentiary package for U.S. and Japanese marketing applications. Verrica and Torii intend to file in their respective markets based on the combined Phase 3 results.

For regulatory affairs leads tracking the dermatology pipeline, the interim analysis methodology is worth noting: the power analysis was executed per-protocol by an independent statistician, preserving blinding integrity across the company and study team. That design choice reduces the risk of protocol amendments that could complicate a future 21 CFR Part 312 submission or invite FDA queries around adaptive trial conduct. The Phase 2 COVE-1 study previously demonstrated reductions in wart count, complete clearance rates, and durability of clearance, providing the clinical rationale underpinning the Phase 3 program design.

Topline readout from COVE-2 in Q1 2027 will serve as the first measurable checkpoint for whether Verrica's label expansion strategy advances toward a formal NDA submission.

Source: Verrica Pharmaceuticals Inc. via GlobeNewswire, August 27, 2026.