JAMA Dermatology Publishes Results from Verrica’s Two Pivotal Phase III CAMP (Cantharidin Application in Molluscum Patients...
September 23 2020 - 4:05PM
Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a
dermatology therapeutics company developing medications for skin
diseases requiring medical interventions, today announced that
positive results from the two pivotal Phase III CAMP (Cantharidin
Application in Molluscum Patients [CAMP-1 and CAMP-2]) studies
evaluating the safety and efficacy of VP-102 in children and adults
with molluscum were published in the Journal of the American
Medical Association (JAMA) Dermatology.
The CAMP studies evaluated a topical application
of VP-102, a propriety drug-device combination containing
cantharidin 0.7% (w/v) in a shelf-stable formulation, in over 500
children and adults with molluscum at 31 treatment sites. Treatment
with VP-102 demonstrated superior results compared to vehicle in
the percentage of participants with complete clearance of molluscum
lesions at the end of the trial (day 84). In CAMP-1, 46% of
participants treated with VP-102 achieved complete clearance of
molluscum lesions compared to 18% of participants in the vehicle
group (p<0.001); in CAMP-2, 54% of participants treated with
VP-102 achieved complete clearance of molluscum lesions compared to
13% of participants in the vehicle group (p<0.001). VP-102 was
well-tolerated in both trials, with no serious adverse events
reported in VP-102 treated subjects. The results were previously
presented at the 2019 American Academy of Dermatology (AAD) annual
meeting in a late-breaking oral presentation.
“Publication in JAMA Dermatology is a
significant achievement for our company and highlights the robust
body of data supporting the potential of VP-102 as a safe and
effective topical therapy for molluscum, a viral skin infection for
which there are no FDA-approved treatments,” commented Ted White,
Verrica President and CEO. “We are proud to advance the field of
medical dermatology by completing the first large-scale, randomized
controlled trials evaluating cantharidin with a consistent
formulation, dosing schedule, and method of application for the
treatment of molluscum. Compounded cantharidin is associated with
the treatment of molluscum, but patients and physicians do not
currently have access to a proven safe and standardized
formulation. VP-102 has the potential to be the first product in
commercial development to enable consistent and safe application of
topical cantharidin. We look forward to potentially bringing VP-102
therapy to the millions of molluscum patients, primarily children,
who are in need of a safe and effective FDA-approved
treatment.”
The published article, “Safety and Efficacy of
VP-102, a Proprietary, Drug-Device Combination Product Containing
Cantharidin, 0.7% (w/v), in Children and Adults with Molluscum
Contagiosum,” can be accessed on the JAMA Dermatology website and
the Publications section of the Verrica website at
www.verrica.com.
About Verrica Pharmaceuticals
Inc.
Verrica is a dermatology therapeutics company
developing medications for 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. Verrica submitted an NDA for VP-102 for the
treatment of molluscum in September 2019. A Complete Response
Letter was received from the FDA regarding the NDA for VP-102 on
July 13, 2020. If approved, VP-102 will be marketed in the United
States under the conditionally accepted brand name YCANTH™. In
addition, Verrica has successfully completed a Phase 2 study of
VP-102 for the treatment of common warts and is currently
conducting a Phase 2 study of VP-102 for the treatment of external
genital warts. The Company is also developing VP-103, its second
cantharidin-based product candidate, for the treatment of 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 Company’s
expectations with regard to its interactions and communications
with the FDA, the potential approval of the NDA for VP-102
following resubmission, and the potential benefits and potential
commercialization of VP-102 for the treatment of molluscum, if
approved. 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 June 30, 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 Davis
Chief Financial Officer
484.453.3300 ext. 103
info@verrica.com
William Windham
Solebury Trout
646.378.2946
wwindham@troutgroup.com
Media:
Zara Lockshin
Solebury Trout
646.378.2960
zlockshin@troutgroup.com
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