Verrica Pharmaceuticals Announces Presentation of Positive Data from Clinical Trials of VP-102 at the 2019 39th Annual Fall ...
October 18 2019 - 7:00AM
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 the
presentation of positive data from three abstracts evaluating the
efficacy and safety of VP-102 (cantharidin 0.7% Topical Solution),
the Company’s lead product candidate for the treatment of molluscum
contagiosum and common warts. These data are being presented in
poster form at the 2019 39th Annual Fall Clinical Dermatology
Conference in Las Vegas, NV.
Data from a pooled analysis of the Phase 3 CAMP-1 and CAMP-2
clinical studies showed that treatment with VP-102 brought about a
statistically significantly higher rate of complete lesion
clearance at Day 84 (primary endpoint) compared to vehicle.
Complete clearance of all molluscum lesions at the end of study
(EOS) visit occurred in 50% of subjects treated with VP-102, as
compared to 15.6% for vehicle (p<0.0001). In addition, mean
lesion counts decreased by 76% for subjects in the VP-102 group,
compared to a 0.3% decrease in the vehicle arm by the EOS visit
(p<0.0001). VP-102 was well-tolerated, and adverse events were
primarily mild to moderate in intensity, with the most common
adverse events related to the pharmacodynamic action of
cantharidin, including application site vesicles, pruritus, pain,
erythema, and scab. Rates of discontinuation of study medication
due to an adverse event were low (1.9% for VP-102; 0.5% for
vehicle).
“This pooled analysis of the pivotal CAMP studies reinforces the
body of evidence demonstrating that VP-102 may be an important
treatment option for molluscum, a highly contagious viral skin
infection for which there are no FDA-approved therapies,” said
Lawrence Eichenfield, MD, Chief of Pediatric and Adolescent
Dermatology, Rady Children’s Hospital, San Diego, CA, and principal
investigator of the VP-102 Phase 3 molluscum program. “These data
show that VP-102 has the potential to address a demonstrated unmet
medical need—safely and effectively clearing the
contagious molluscum lesions that can spread rapidly, may cause
pain and discomfort, and can have a substantial negative impact on
patient quality-of-life.”
A second pooled analysis of the CAMP studies evaluated the time
course and percentage of subjects with > 75% and > 90%
reduction in lesions at the EOS visit in the intent-to-treat
population. Data demonstrated that as early as Day 21, > 75% and
> 90% lesion clearance rates were statistically significantly
higher with VP-102 treatment as compared to vehicle (p<0.0001).
At EOS, 77.7% of VP-102 subjects achieved > 75% reduction in
lesions compared to 34.9% for vehicle, and 65.8% of VP-102 subjects
achieved > 90% reduction of lesions compared to 27.1% for
vehicle (p<0.0001 respectively).
“These data are of significant clinical value,” continued Dr.
Eichenfield. “Even a reduction of molluscum lesions may reduce
viral burden, decrease auto-inoculation, and limit virus
transmission to others.”
Investigating VP-102 for the Treatment of Common
Warts
The Phase 2 COVE-1 open label study evaluated the efficacy and
safety of VP-102 in subjects with up to six common warts in two
cohorts. Cohort 2 subjects receiving VP-102 showed a change of
-50.9% of common warts and 51.4% of subjects showed complete
clearance of warts at the primary endpoint of Day 84. Clinical
response was maintained through the follow-up period, with a 45.5%
mean reduction of warts compared to baseline, and 40% of subjects
showing complete clearance at Day 147. Due to the higher complete
clearance rates observed in Cohort 2 (51% of subjects showing
complete clearance at Day 84), Verrica intends to use the treatment
regimen of Cohort 2 (up to four treatments of VP-102 every 21 days
with paring of thick scale and occlusion) in future Phase 3
studies. In the COVE-1 study, VP-102 showed a favorable
tolerability and acceptable safety profile. The most common adverse
events were mild to moderate in severity, and included application
site blistering, pain, pruritus, erythema, and scab, and were
considered related to the pharmacodynamic action of
cantharidin.
“The results from the CAMP and COVE studies clearly demonstrate
that VP-102 has the potential to address the substantial burden of
molluscum, as well as provide an important therapeutic option to
treat common warts,” said Ted White, President and Chief Executive
Officer of Verrica. “The presentation of these data is a critical
step forward towards achieving our mission of providing a safe,
effective therapy to address these two important unmet needs.”
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, the Company submitted an NDA in September 2019 for VP-102
for the treatment of molluscum. 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 a Phase 2 trial 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 benefits of VP-102 for the treatment of
molluscum and the clinical development of VP-102 for additional
indications, including the design of future Phase 3 studies for the
treatment of common 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.
FOR MORE INFORMATION, PLEASE CONTACT:
Investors:
A. Brian DavisChief Financial
Officer484.453.3300 ext. 103info@verrica.com
Chiara RussoSolebury
Trout617.221.9197crusso@soleburytrout.com
Media:
Joshua R. MansbachSolebury
Trout646-378-2964jmansbach@troutgroup.com
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