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
positive topline results from its COVE-1 Phase 2 open label
clinical study of VP-102 for the treatment of verruca vulgaris, or
common warts. COVE-1 included two cohorts that evaluated the safety
and efficacy of VP-102, a novel topical therapy containing a
solution of 0.7% cantharidin in a proprietary single-use
applicator, in subjects with up to six warts. In both cohorts,
VP-102 achieved positive results on both the primary endpoint of
complete clearance of all treatable warts at Day 84 and the
secondary endpoint of the percentage reduction of warts. VP-102 was
well-tolerated with no serious adverse events reported.
“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 Ted White, President and Chief
Executive Officer of Verrica. “We are progressing the development
of VP-102 for a broad range of skin diseases. We intend to request
an ‘End of Phase 2’ meeting with the FDA for the treatment of
common warts, and remain on track to submit an NDA for the
treatment of molluscum contagiosum later this year.”
Study Results:
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 FDA-approved
treatments,” said Scott T. Guenthner, MD, FAAD, founder of the
Dermatology Center of Indiana and lead investigator for the COVE-1
study. “Further, common warts are very persistent and difficult to
treat, which is frustrating to patients. The data results on the
complete clearance of treatable warts and the percentage of wart
reduction in this Phase 2 study is very meaningful and highlight
the potential of VP-102 as an important new option for people with
common warts.”
In addition to requesting an End of Phase 2 meeting with the FDA
on next steps for the development of VP-102 for the treatment of
common warts, Verrica plans to submit this data for presentation at
future medical meetings and for publication in a peer-reviewed
medical journal.
Verrica Conference Call
Management will conduct a conference call at 8 a.m. ET tomorrow,
June 27, 2019, to discuss the results. The conference call will be
webcast and can be accessed by logging on to the “Investors”
section of the Verrica website, www.verrica.com, prior to the
event.
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.
About Verrica Pharmaceuticals
Inc.
Verrica Pharmaceuticals Inc. 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. An additional
Phase 2 trial is planned in external genital warts. A second
product candidate, VP-103, is in pre-clinical development for
plantar warts. For more information, visit www.verrica.com.
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 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.
Contacts
Chris 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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