Verrica Pharmaceuticals has completed patient enrolment in its first pivotal Phase III trial, COVE-2, which is part of a global clinical programme evaluating Ycanth (VP-102), to treat common warts.
Top line data from the trial are anticipated in the first quarter of 2027.
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Conducted in the US, the COVE-2 trial follows a previously completed Phase II trial that had shown a decline in the number of common warts, patients achieving complete clearance, and durability of clearance in many cases.
It is the first of two double-blind, vehicle-controlled, randomised trials assessing the safety and efficacy of VP-102/TO-208.
Both studies are designed to test application of the treatment once every 21 days, for up to four applications, in patients aged two years and older with common warts.
The company also reported that the second pivotal trial, COVE-3, which is recruiting in both the US and Japan, has already exceeded 50% of its current enrolment target ahead of schedule.
The interim analysis of COVE-2 was conducted by an independent statistician to assess study power and recommended no need for additional subjects. Verrica Pharmaceuticals remains blinded to the specific data outcomes.
Verrica president and CEO Jayson Rieger said: “I am very pleased to announce substantial progress in our global Phase III programme seeking to expand the label for Ycanth to include common warts.
“We have now completed enrolment 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.”
The global Phase III programme also includes a supportive long-term follow-up study (COVE-4) and a pharmacokinetics trial (COVE-5).
Verrica and its Japanese partner, Torii Pharmaceutical plan to seek marketing approval in the US and Japan based on the results from these trials.
The companies are sharing the costs of the programme, with Torii funding the first $40m, representing approximately 90% of current costs.
In January 2024, Verrica Pharmaceuticals dosed the last patient in part two of the Phase II trial of VP-315, a new oncolytic peptide immunotherapy for basal cell carcinoma.
