Verrica Pharmaceuticals Announces Positive Topline Results in Phase 2 Clinical Study of VP-102 in Patients with External Geni...
November 10 2020 - 7:30AM
Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a
dermatology therapeutics company developing medications for skin
diseases requiring medical interventions, today announced positive
topline results from its Phase 2 CARE-1 clinical study of VP-102, a
novel topical therapy containing a solution of 0.7% (w/v)
cantharidin in a proprietary single-use applicator, in external
genital warts (EGW). VP-102 achieved positive results on both the
primary endpoint of complete clearance of all treatable EGW at Day
84 and the secondary endpoint of the percentage reduction of EGW at
Day 84.
“The positive results of the Phase 2 CARE-1
trial suggest that VP-102 has the potential to provide patients and
physicians with a well-tolerated and effective option for
treatment,” said Gary Goldenberg, MD, Chief Medical Officer of
Verrica. “Based on the positive outcome from CARE-1, we intend to
request an End-of-Phase 2 meeting with the FDA for the treatment of
EGW in the first quarter of 2021.”
“EGW, otherwise known as condyloma acuminata,
are one of the most common sexually-transmitted infections in the
U.S., often resulting in substantial social stigma, negative impact
on quality of life, and an increased risk of HPV-related cervical
cancer,” said Neal Bhatia, MD, Director of Clinical
Dermatology at Therapeutics Clinical Research in San Diego.
“Undertreatment of EGW presents an interdisciplinary public health
issue, as patients often seek treatment from a variety of
sources including dermatologists, urologists, gynecologists, and
primary care physicians. Newer medical therapeutic advances may
offer more tolerable and effective approaches to controlling the
spread of EGW and therefore can improve outcomes for these
patients.”
CARE-1 was a Phase 2, double-blind,
vehicle-controlled clinical study of VP-102 to determine the dose
regimen, efficacy, safety, and tolerability of VP-102 in subjects
with EGW in subjects 18 years of age or older. The study included
two sequential parts: Part A and Part B. Part A was conducted in 18
subjects at four research sites. Subjects received treatment with
VP-102 to treatable EGW every 21 days for up to four treatments and
were told to wash off VP-102 within either 2, 6, or 24 hours of
application. Safety results from Part A supported use of VP-102 for
both 6-hour and 24-hour treatment exposures in Part B.
Part B was conducted in an additional 87 subjects at nine
research sites comparing vehicle to VP-102 applied for either 6 or
24 hours for up to four treatments. The primary analyses were
conducted at Day 84. Topline analyses included data from the
assessment of EGW at study visits at days 21, 42, 63, and 84.
Study Results and Demographics:
- Subjects presented with a mean wart
count of 8.2 with a range of 2 to 30 EGW at baseline. Approximately
50% of subjects had EGW for one year or longer; approximately 23%
of subjects had EGW for more than five years.
- Pooled results from the 6- and
24-hour treatment exposures showed 35.1% (20/57) of subjects
treated with VP-102 achieved complete clearance of all treatable
EGW at Day 84 compared to 2.4% (1/42) of subjects treated with
vehicle (p=0.0001).
- For both the 6- and 24-hour
treatment exposures, subjects treated with VP-102 achieved
statistically significantly larger reductions in percent change
from baseline in the number of treatable EGW compared to vehicle at
Day 84: 6-hour (p< 0.0001), 24-hour group (p=0.0003).
- VP-102 was well-tolerated. Side
effects experienced by the VP-102 treated subjects were consistent
with the pharmacodynamic action of cantharidin as a blistering
agent. These side effects were primarily mild-to-moderate and
included application site vesicles, pain and erythema. No subjects
discontinued from the study due to adverse events and there were no
serious adverse events reported that were considered related to
treatment by the investigator.
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
EGW, Verrica plans to submit the Phase 2 CARE-1 data for
presentation at future medical meetings and for publication in a
peer-reviewed medical journal.
About Genital WartsGenital
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 (Yanofsky 2012 Clinical and Aesthetic
Dermatol). 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. The Company’s late-stage product candidate, VP-102,
is a potential first-in-class drug-device combination product
containing a 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. In October 2020, Verrica participated in a Type A meeting
with the FDA. Verrica expects to resubmit its New Drug Application
for VP-102 for the treatment of molluscum in the first quarter of
2021. 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. The Company is also developing
VP-103, its third cantharidin-based product candidate, for the
treatment of plantar warts. For more information, visit
www.verrica.com.
Forward-Looking StatementAny 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
benefits and clinical development plan for VP-102 for the treatment
of EGW, Verrica’s interactions and communications with the FDA, and
the potential approval of VP-102 to treat EGW, common warts and
molluscum. 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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