News Release Details
Verrica Pharmaceuticals Enrolls First Patient in Phase 2 Trial of VP-102 for the Treatment of External Genital Warts
“Currently, there are limited treatment options for patients with external genital warts,” said
“The management of genital warts can be very challenging and a substantial burden for patients. Treatment is focused on making patients comfortable while clearing the lesions and ultimately reducing the risk of virus transmission,” said
The Phase 2 clinical trial is a multi-center, double-blind, placebo-controlled study comprised of two parts (Part A and Part B). In Part A, subjects with external genital warts will be randomized into three treatment groups, a 2-hour, 6-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
About External Genital Warts
External genital warts (EGW) are a viral skin disease caused by the human papilloma virus, or HPV, which forms lesions on the surface of the skin. HPV is the most common sexually transmitted infection in
Verrica is a medical dermatology company committed to the development and commercialization of novel treatments that provide meaningful benefit for people living with skin diseases. The company’s late-stage product candidate, VP-102, is a potential first-in-class topical therapy for the treatment of molluscum contagiosum and common warts. Molluscum is a highly contagious viral skin infection affecting approximately six million people, primarily children, in
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include expectations regarding the potential submission of a new drug application in the second half of 2019 for VP-102 for the treatment of molluscum and the potential benefits of VP-102 for the treatment of external genital warts. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, Verrica’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended
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Source: Verrica Pharmaceuticals Inc.