Verrica Pharmaceuticals Presents Positive Data From Clinical Studies Evaluating the Safety and Efficacy of VP-102 in Molluscu...
January 19 2021 - 7:00AM
Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a
dermatology therapeutics company developing medications for skin
diseases requiring medical interventions, today announced the
presentation of positive data from post-hoc pooled analyses of the
pivotal Phase 3 CAMP trials evaluating the safety and efficacy of
VP-102, Verrica’s lead product candidate, in molluscum contagiosum
(molluscum) in specific body regions at each visit. The data were
presented in poster format online for the 2021 Winter Clinical
Dermatology Conference.
“We are pleased to present further positive data supporting
VP-102 as a potentially safe and efficacious treatment for
molluscum,” said Gary Goldenberg, M.D., Chief Medical Officer at
Verrica. “VP-102, our lead candidate, continues to demonstrate
positive results as we advance development of the program in
molluscum, external genital warts and common warts, three of the
largest unmet needs in medical dermatology.”
Results showed that VP-102-treated participants with lesions in
the upper extremities, head/neck, back/buttocks, and chest/abdomen
at baseline showed statistically significantly higher rates of
complete clearance in those regions compared to vehicle beginning
after the first treatment (Visit 2; Day 21) through the EOS visit.
VP-102-treated participants with lesions in the lower extremities
at baseline showed statistically significantly higher complete
clearance rates compared to vehicle-treated participants beginning
after two treatments (Visit 3; Day 42) through the EOS visit (Day
84). The incidence of adverse events was similar in all body
regions.
Data were also presented from Verrica’s Phase 2 CARE-1 clinical
study of VP-102 in external genital warts (EGW). Results showed
that treatment with VP-102 resulted in a statistically
significantly higher complete clearance rate of all EGW compared to
vehicle at Visit 4 (Day 63) and at the End of Treatment Visit (Day
84) regardless of drug exposure duration (6 or 24 hours). Incidence
of adverse events were primarily mild to moderate and similar
across VP-102 drug exposure groups.
The presentations are available on the Publications section of
Verrica’s website at www.Verrica.com.
About VP-102
Verricaʼs lead product candidate, VP-102, is a proprietary
drug-device combination product that contains a GMP-controlled
formulation of cantharidin (0.7% w/v) delivered via a single-use
applicator that allows for precise topical dosing and targeted
administration. VP-102 is currently under U.S. Food and Drug
Administration (FDA) review and could potentially be the first
product approved by the FDA to treat molluscum contagiosum ― a
common, highly contagious skin disease that affects an estimated
six million people in the United States, primarily children. 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 a Phase 2 study of VP-102 for the treatment of
external genital warts.
About Molluscum Contagiosum (Molluscum)
There are currently no FDA-approved treatments for molluscum, a
highly contagious viral skin disease that affects approximately six
million people — primarily children — in the United States.
Molluscum is caused by a pox virus that produces distinctive
raised, skin-toned-to-pink-colored lesions that can cause pain,
inflammation, itching and bacterial infection. It is easily
transmitted through direct skin-to-skin contact or through fomites
(objects that carry the disease like toys, towels or wet surfaces)
and can spread to other parts of the body or to other people,
including siblings. The lesions can be found on most areas of the
body and may carry substantial social stigma. Without treatment,
molluscum can last for an average of 13 months, and in some cases,
up to several years.
About Genital Warts
Genital warts (also known as anogenital warts or condyloma
acuminatum) are a sexually transmitted viral infection caused by
multiple different types of the human papilloma virus (HPV).
Approximately 500,000 to 1 million cases of EGW are newly diagnosed
per year in the United States, with clinically apparent warts
presenting in 1% of the sexually active population. HPV is spread
through direct skin-to-skin contact, usually during oral, genital,
or anal sexual contact with an infected partner. Diagnosis of
genital warts is usually made by visual inspection and can be
confirmed by biopsy. The four morphologic types of genital warts
are cauliflower-shaped, smooth papular, keratotic, and flat.
Genital warts cause few symptoms but can occasionally be painful.
Conditions known to predispose women to infection with HPV include
local trauma, diabetes, and immuno-suppression.
About Verrica Pharmaceuticals Inc.
Verrica is a dermatology therapeutics company developing
medications for skin diseases requiring medical interventions.
Verrica’s late-stage product candidate, VP-102, is in development
to treat molluscum contagiosum (molluscum), common warts and
external genital warts, three of the largest unmet needs in medical
dermatology. Verrica is also developing VP-103, its second
cantharidin-based product candidate, for the treatment of plantar
warts. The Company has also entered a worldwide license agreement
with Lytix Biopharma AS to develop and commercialize LTX-315 for
dermatologic oncology conditions. For more information, Visit
www.verrica.com.
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 Company’s expectations with regard to the potential
approval of the NDA for VP-102, the potential benefits and
potential commercialization of VP-102 for the treatment of
molluscum, if approved, and the potential benefits of VP-102 for
the treatment of EGW. 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 September 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 DavisChief Financial
Officer484.453.3300 ext. 103info@verrica.com
William WindhamSolebury
Trout646.378.2946wwindham@troutgroup.com
Media:
Zara LockshinSolebury
Trout646.378.2960zlockshin@troutgroup.com
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