Verrica Pharmaceuticals enrolls first patient in Phase 2 CARE trial
Verrica Pharmaceuticals announced that the first patient has been enrolled in the company's Phase 2 CARE clinical trial evaluating the optimal dose regimen, efficacy, safety and tolerability of VP-102, a novel topical therapy containing a solution of 0.7% cantharidin in a proprietary single-use applicator, in patients with external genital warts.The Phase 2 clinical trial is a multi-center, double-blind, placebo-controlled study comprised of two parts. In Part A, subjects with external genital warts will be randomized into three treatment groups, a two-hour, six-hour or 24-hour duration of skin exposure group and will receive either VP-102 or placebo applied topically. The primary objective of Part A is to identify the two best dosing regimens for evaluation of safety and efficacy in Part B. Treatment dosing regimens will be evaluated by assessing the safety and tolerability of VP-102 when administered topically after all subjects have completed a 48-hour assessment. Subjects will continue to be treated once every 21 days with VP-102 for up to four applications. Part B will evaluate the safety and efficacy of the two selected treatment dosing regimens of VP-102 when administered topically once every 21 days for up to four applications. Based on the study findings, the company intends to identify the VP-102 treatment regimen with the most favorable risk versus benefit profile for potential study in later stage trials. Endpoints assessed will include safety and tolerability, proportion of subjects achieving complete clearance of all treatable warts and change from baseline in the number of treatable warts over an 84-day treatment period. Subjects will also have follow-up visits at Day 112 and Day 147 after the treatment period has been completed. Part A will enroll approximately 18 subjects and Part B of the study will enroll approximately 90 additional subjects. This trial will be conducted at up to nine clinical trial centers across the United States. Topline results are anticipated during the second half of 2020.