Verrica Pharmaceuticals Enrolls First Patient in Phase 2 Trial of VP-102 for the Treatment of External Genital Warts
June 27 2019 - 3:01PM
Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a medical
dermatology company committed to the development and
commercialization of novel treatments that provide meaningful
benefit for people living with skin diseases, today 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.
“Currently, there are limited treatment options for patients
with external genital warts,” said Ted White, President and Chief
Executive Officer of Verrica. “We believe that our novel therapy
has the potential to be a safe and effective treatment for this
indication based on the shared characteristics with molluscum
contagiosum, another highly contagious skin infection for which we
have reported positive data from two pivotal Phase 3 trials
evaluating VP-102.”
“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 Neil Bhatia, MD,
Director of Clinical Dermatology at Therapeutics Dermatology. “It
is important for continued research to find new treatment options
with the potential to clear the warts quickly with a therapy that
is well tolerated. VP-102 has shown promise in other viral skin
diseases, and the dermatology community is eagerly awaiting the
results of the Phase 2 clinical study in genital warts.”
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 the United States. Topline results are anticipated
during the second half of 2020. More information about the trial is
available at www.clinicaltrials.gov, identifier NCT03981822.
About External Genital WartsExternal 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 the United
States. Risk factors for genital warts include multiple sex
partners, early onset of sexual activity, long-term oral
contraceptive use in women and previous history of other sexually
transmitted diseases. An estimated 17 percent of the approximately
4.1 million patient visits for all types of warts are for the
treatment of genital warts.
About Verrica Pharmaceuticals Inc.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
the United States, and common warts are contagious skin growths
affecting 22 million people. There are currently no FDA-approved
treatments for molluscum or common warts. Following positive
topline results from two pivotal Phase 3 trials, a New Drug
Application for VP-102 for the treatment of molluscum is planned
for the second half of 2019. Verrica is planning to meet with the
FDA to determine next steps on the development of VP-102 for common
warts following positive Phase 2 results. VP-102 is also currently
in Phase 2 trials for the treatment of external genital warts. A
second product candidate, VP-103, is in pre-clinical development
for plantar warts. For more information, visit www.verrica.com.
Forward-Looking Statement 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 December 31, 2018, filed with the U.S. Securities and
Exchange Commission on March 7, 2019, and other filings Verrica
makes with the U.S. Securities and Exchange Commission. Any
forward-looking statements speak only as of the date of this press
release and are based on information available to Verrica as of the
date of this release, and Verrica assumes no obligation to, and
does not intend to, update any forward-looking statements, whether
as a result of new information, future events or otherwise.
ContactsChris
DegnanChief Financial Officer484.453.3300 ext.
103info@verrica.com
Patti BankManaging
DirectorWestwicke Partners, an ICR
Company415.513.1284patti.bank@westwicke.com
For Media:Mike Beyer Sam Brown
Inc. Healthcare Communications 312.961.2502
mikebeyer@sambrown.com
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