News Release Details
Verrica Pharmaceuticals Achieves Positive Topline Results in Phase 2 Clinical Study of VP-102 in Patients with Common Warts
51% of subjects in Cohort 2 achieved complete clearance of all treatable warts
VP-102 was well-tolerated with no serious adverse events reported
Common warts affect approximately 22 million people in
Based on positive outcome, Verrica to request an ‘End of Phase 2’ meeting with the
Management to host webcast and conference call tomorrow at
“This is exciting news for Verrica and our proprietary cantharidin product. Positive Phase 2 data of VP-102 for the treatment of common warts, after the successful Phase 3 results achieved with VP-102 for molluscum contagiosum, further increases our confidence in the broad clinical utility and large market potential of our lead product,” said
The COVE-1 Phase 2 open label clinical study included two cohorts that evaluated the safety and efficacy of VP-102 in subjects with up to six warts. Cohort 1 was conducted at a single site with 21 subjects age 2 years and older receiving up to 4 treatments with VP-102 at least 14 days between treatments with longer treatment intervals allowed at the discretion of the investigator depending on a specific subject’s clinical response. While the study was ongoing, Verrica amended the protocol to allow varying treatment intervals in Cohort 1 at the discretion of the investigator in order to identify the optimal treatment dosing regimen and added a second cohort to the study.
Cohort 2 was conducted at four sites with 35 subjects age 12 years and older receiving up to 4 treatments with VP-102 every 21 days. Paring of warts, a technique commonly used by dermatologists to prepare the wart for treatment, was allowed in Cohort 2 to remove any adherent thick scale from a wart prior to application of study drug. The primary analysis was conducted at Day 84 with an additional period of follow-up through Day 147. Topline analysis included data from the assessment of warts at study visits over 12 weeks. Results showed 51% of subjects (18 of 35) treated with VP-102 in Cohort 2 achieved complete clearance of all treatable warts at Day 84. Secondary endpoints included the percent change from baseline in the number of treatable warts and VP-102 achieved a 51% reduction in the number of warts (28 of 55 warts) compared to baseline by Day 84.
Consistent with the results from the Phase 3 clinical trials in molluscum, VP-102 was also well-tolerated with side effects that were primarily mild-to-moderate. The most frequently reported adverse events were application site reactions that are well-known, reversible side effects related to the mechanism of action of cantharidin, a blistering agent, which is the active ingredient in VP-102. There were no serious adverse events reported.
“Behind acne, warts are the most common dermatological complaint and our treatment options are limited as there are no
In addition to requesting an End of Phase 2 meeting with the
Verrica Conference Call
Management will conduct a conference call at
The webcast will also be available via the following link: https://edge.media-server.com/m6/p/ju8namrg. A replay of the webcast will be archived on the Company’s website for 30 days following the call.
To participate on the live call, please dial 866-688-9534 (domestic) or 409-216-0837 (international), and reference conference ID 7183118 prior to the start of the call.
About Common Warts
Common warts (verruca vulgaris) are skin growths caused by a contagious viral skin infection, most commonly on the fingers or hands. The human papilloma virus (HPV), the causative agent in common warts, is transmitted by touch. The virus enters the skin and causes skin growths by inducing the skin cells to multiply rapidly. Common warts are benign, but treatment is recommended to prevent the spread of infection and relieve the patient’s physical and psychological discomfort.
Cautionary Note Regarding Forward-Looking Statements
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 further advancement of VP-102 for the treatment of common warts, submission of a NDA in the second half of 2019 for VP-102 for the treatment of molluscum and the large market potential of VP-102. 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.