Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a
dermatology therapeutics company developing medications for viral
skin diseases requiring medical interventions, today announced the
presentation of new pooled data from two analyses of the Phase 3
CAMP trials of VP-102 (cantharidin 0.7% topical solution),
Verrica’s lead product candidate for the treatment of molluscum
contagiosum (molluscum). These data are available in poster format
online by the American Academy of Dermatology for the 2020 annual
meeting, which was previously scheduled for March 20-24 in Denver,
Colorado.
A pre-specified exploratory analysis of pooled data demonstrated
that, regardless of lesion count, all VP-102 quartiles had
statistically significantly higher percentage of patients with
complete clearance of all baseline and new lesions as compared to
vehicle (p<0.05), and that complete clearance rates were similar
across all VP-102 quartiles.
In this analysis, patients treated with VP-102, across all
lesion count quartiles, were similar in baseline characteristics
and molluscum medical histories. Participants were segmented by
baseline lesion count: Quartile 1) 1-7 lesions (n=94); Quartile 2)
8-14 lesions (n=82); Quartile 3) 15-28 lesions (n=67); and,
Quartile 4) 29-184 lesions (n=68). Mean age of patients was:
Quartile 1) 9.0 years; Quartile 2) 7.5 years; Quartile 3) 6.0
years; and, Quartile 4) 6.7 years. Mean time since clinical
diagnosis was: Quartile 1) 134.3 days; Quartile 2) 116.8 days;
Quartile 3) 121.0 days; and, Quartile 4) 118.2 days. At baseline,
the percentage of patients presenting with a history of atopic
dermatitis (AD), or with active AD, included: Quartile 1) 8%;
Quartile 2) 7%; Quartile 3) 16%; and, Quartile 4) 19%. Selected
treatment-emergent adverse events at the application site were
similar across quartiles with VP-102 treatment including vesicles,
pain, scab, erythema, pruritus, discoloration, dryness, edema,
erosion, and scarring.
“These data are important, as they show that VP-102 has the
potential to effectively and safely treat molluscum patients – and
achieve complete clearance – regardless of the number of lesions,”
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.
“Historically, patients with high lesion counts, a group addressed
in this analysis, have been challenging to treat.”
The second abstract is a post-hoc analysis in which
VP-102-treated subjects were categorized by those who achieved
complete lesion clearance (CC) and those who did not (NC) by the
end of study visit (EOS, Day 84), to compare demographics and
outcomes between the groups, and identify characteristics
potentially predictive of response to treatment with VP-102. The
analysis demonstrated that in patients treated with VP-102,
baseline demographics and medical histories were similar between
the CC group and the NC group at EOS. Safety outcomes were similar
in both groups, except for application site pain and pruritus (both
were higher in the NC group). Baseline lesion count was not
clinically different, and there was no difference in time since
diagnosis between groups, age, gender, previous treatment, or
atopic dermatitis history or status. These results demonstrated
that any patient who fits the requirements of the study protocol
and has similar characteristics could potentially achieve complete
clearance of all baseline and new molluscum lesions after up to
four treatments with VP-102.
“These two analyses of the Phase 3 CAMP trials add to the body
of evidence that supports the safety and efficacy profile of
VP-102,” said Ted White, President and Chief Executive Officer,
Verrica. “In these analyses, we see clear evidence that regardless
of how many lesions a patient has, or what their baseline
characteristics may be, VP-102 has the potential to be a viable
treatment option to help patients with molluscum achieve complete
lesion clearance.”
About Verrica Pharmaceuticals Inc.
Verrica is a dermatology therapeutics company developing
medications for viral skin diseases requiring medical
interventions. 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 on
September 13, 2019 for VP-102 for the treatment of molluscum; on
November 26, 2019, the Company received notice that the FDA
accepted the NDA for filing, with a Prescription Drug User Fee Act
(PDUFA) goal date of July 13, 2020. If approved, VP-102 will be
marketed in the United States under the conditionally accepted
brand name YCANTH™. Verrica has completed a Phase 2 clinical trial
of VP-102 for the treatment of verruca vulgaris, or common warts
and, in light of the COVID-19 pandemic, intends to launch two Phase
3 clinical trials when conditions are appropriate. VP-102 is also
currently in a Phase 2 trial for the treatment of external genital
warts. The Company is conducting necessary preclinical activities
for VP-103, its second cantharidin-based product candidate, and, in
light of the COVID-19 pandemic, intends to launch a Phase 2
clinical trial in subjects with plantar warts when conditions are
appropriate. 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 and potential approval and
commercialization of YCANTH™ for the treatment of molluscum, and
the clinical development of product candidates for additional
indications, including common warts, external genital warts and
plantar 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, uncertainties related to the
COVID-19 pandemic and other risks and uncertainties that are
described in Verrica’s Annual Report on Form 10-K for the year
ended December 31, 2019, Verrica’s Quarterly Report on Form
10-Q for the quarter ended March 31, 2020, 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
Luke BrownSolebury
Trout646.378.2944lbrown@troutgroup.com
Media:
Joshua R. MansbachSolebury
Trout646.378.2964jmansbach@troutgroup.com
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