Aclaris Therapeutics’ A-101 45% Topical Solution Meets Primary and All Secondary Efficacy Endpoints in Pivotal Phase 3 Tria...
16 September 2019 - 10:15PM
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led
biopharmaceutical company focused on immuno-inflammatory and
dermatological diseases, today announced positive results from its
Phase 3 clinical trial, THWART-2 (WART-302), of A-101 45% Topical
Solution (A-101 45% Topical Solution), an investigational new drug
for the treatment of common warts (verruca vulgaris). A-101 45%
Topical Solution met the primary and all secondary efficacy
endpoints, achieving clinically and statistically significant
clearance of common warts. A-101 45% Topical Solution is a
proprietary high-concentration hydrogen peroxide topical solution
being developed as a potential prescription treatment for common
warts.
THWART-2 is one of two randomized double-blind
vehicle-controlled Phase 3 pivotal trials conducted by Aclaris to
evaluate A-101 45% Topical Solution as a potential treatment for
common warts. Aclaris expects to report data from THWART-1
(WART-301), the second Phase 3 trial during the fourth quarter of
2019. Both trials evaluated the efficacy and safety of A-101 45%
Topical Solution as compared to placebo (vehicle). The two
randomized, double-blind, vehicle-controlled trials were designed
to demonstrate the efficacy and safety of A-101 45% Topical
Solution for the potential treatment of common warts when applied
by subjects (or the parents/guardians of subjects < 18
years).
In the THWART-2 trial, 502 subjects who had one to six warts at
baseline were randomized and self-administered either A-101 45%
Topical Solution or vehicle twice a week over 8 weeks, for a total
of 16 treatments. The trial achieved its primary endpoint with a
high degree of statistical significance (p<0.0001), i.e. a
higher proportion of subjects treated in the A-101 45% Topical
Solution arm versus vehicle had all their identified common warts
reported as clear at Day 60. Warts were assessed using the
Physician Wart Assessment scale (PWA=0) which is a validated
four-point scale of the investigators’ assessment of the severity
of all treated warts.
In the trial, all secondary efficacy endpoints achieved
statistical significance in favor of A-101 45% Topical Solution
versus vehicle and are described as follows:
- Complete clearance of all warts at Day 137 (12 weeks after last
treatment) (p=0.0001)
- Mean per subject percent of treated warts cleared at Day 137
(p<0.0001)
- Clearance in subjects with a single baseline wart at Day 60
(p=0.0006)
- Time to complete clearance of all warts (p<0.0001)
There were no treatment-related serious adverse events (SAEs) in
subjects treated with A-101 45% Topical Solution; however, SAEs of
intestinal obstruction (in the A-101 45% Topical Solution group)
and staghorn renal calculus (vehicle group) were assessed by the
investigators as unrelated. Treatment-related application site
adverse events (AEs) were reported in 53.4% and 8.4% of the A-101
45% Topical Solution and vehicle groups respectively. In the active
arm 2% (5 subjects) of application site events were severe (1 pain,
and 4 site pallor). The most common AEs (occurring in more than 5%
of subjects) were application site pain, pallor, erythema,
pruritus, scabbing and erosion. No subjects withdrew because of
AEs.
“There are no FDA approved prescription treatments for common
warts and we are excited by these data and look forward to the
results of the second pivotal Phase 3 trial, THWART-1 (WART-301),”
said Dr. Neal Walker, President and CEO of Aclaris. “This treatment
is self-administered twice a week for 8 weeks (a total of 16
applications) and we believe these results will be of interest to
partners seeking to commercialize A-101 45% Topical Solution.”
About Common Warts
Common warts, also called verruca vulgaris, are skin growths
caused by a virus infecting the top layer of the skin. They affect
an estimated 22 million Americans each year with a higher incidence
in children than adults. Common warts are often skin-colored and
feel rough but can be darker and smooth. Symptoms include pain,
bleeding, itching, and burning. Common warts are contagious and may
interfere with social activities, cause embarrassment, and carry a
social stigma. Each year, over 2 million people in the U.S. are
diagnosed with common warts during a visit to a health care
professional.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical
company committed to addressing the needs of people with
immuno-inflammatory and dermatological diseases who lack
satisfactory treatment options. The company’s diverse and
multi-stage portfolio includes two FDA-approved medicines, one
late-stage investigational medicine, and a pipeline powered by a
robust R&D engine exploring protein kinase regulation. For
additional information, please visit www.aclaristx.com and
follow Aclaris on LinkedIn or Twitter @aclaristx.
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 Aclaris' current beliefs and
expectations. These forward-looking statements include expectations
regarding the development of Aclaris’ drug candidates, including
A-101 45% Topical Solution, and the potential for partnerships for
commercializing A-101 45% Topical Solution. 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 conduct of
clinical trials and in commercialization of products, Aclaris'
reliance on third parties over which it may not always have full
control, and other risks and uncertainties that are described in
the Risk Factors section of Aclaris’ Annual Report on Form 10-K for
the year ended December 31, 2018, Aclaris Quarterly report on Form
10-Q for the quarter ended June 30, 2019, and other filings Aclaris
makes with the U.S. Securities and Exchange Commission from time to
time. These documents are available under the "SEC filings” section
of the Investors page of Aclaris' website at
http://www.aclaristx.com. Any forward-looking statements speak only
as of the date of this press release and are based on information
available to Aclaris as of the date of this release, and Aclaris
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.
Aclaris ContactMichael Tung, M.D.Senior Vice
President Corporate Strategy/Investor
Relations484-329-2140mtung@aclaristx.com
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