Aclaris Therapeutics’ A-101 45% Topical Solution Meets Primary and All Secondary Efficacy Endpoints in Second Successful Pi...
October 24 2019 - 4:01PM
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led
biopharmaceutical company focused on immuno-inflammatory diseases,
today announced positive results from its second Phase 3 clinical
trial, THWART-1 (WART-301), of A-101 45% Topical Solution (A-101
45%), an investigational new drug, for the potential treatment of
common warts (verruca vulgaris). A-101 45% met the primary and all
secondary efficacy endpoints, achieving clinically meaningful and
statistically significant clearance of common warts. A-101 45% is a
proprietary high-concentration hydrogen peroxide topical solution
being developed as a potential prescription treatment for common
warts.
THWART-1 is the second of two Phase 3 pivotal trials: THWART-1
and THWART-2 (WART-301 and WART-302, respectively) conducted by
Aclaris. The two randomized, double-blind, vehicle-controlled
trials were designed to evaluate the efficacy and safety of A-101
45% as compared to placebo (vehicle) for the treatment of common
warts when applied by subjects (or the parents/guardians of
subjects < 18 years).
The THWART-1 trial randomized 503 subjects who self-administered
either A-101 45% or vehicle twice a week over 8 weeks, for a total
of 16 treatments. Each subject had one to six common warts at
baseline. The trial achieved its primary endpoint with a high
degree of statistical significance (p=0.0003), i.e. a higher
proportion of subjects treated with A-101 45% versus vehicle had
all their identified common warts reported as clear at day
60. Warts were assessed using the Physician Wart
Assessment™ scale which is a validated four-point scale of the
investigators’ assessment of the severity of all treated common
warts (PWA=0 means clear). All secondary efficacy endpoints
also achieved statistical significance in favor of A-101 45% versus
vehicle.
Efficacy results from the THWART-1 and THWART-2 trials for the
primary and first two secondary endpoints are summarized in the
table below:
|
PRIMARYProportion of subjects whose identified
common warts are determined to be clear at day 60 (PWA=0) (%) |
SECONDARYProportion of subjects whose identified
common warts are determined to be clear at day 137 (PWA=0)
(%) |
SECONDARYMean per-subject percent of all common
warts that are clear at day 137 (PWA=0)(%) |
THWART-1 |
|
|
|
A-101 45% (n=254) |
15.7% |
22.4% |
28.6% |
VEHICLE (n=249) |
5.2% |
11.6% |
14.5% |
p-value |
0.0003 |
0.0024 |
<0.0001 |
|
|
|
|
THWART-2 |
|
|
|
A-101 45% (n=251) |
13.1% |
22.3% |
27.7% |
VEHICLE (n=251) |
3.2% |
10% |
12.2% |
p-value |
<0.0001 |
0.0001 |
<0.0001 |
In the THWART-1 trial, the two other secondary efficacy
endpoints also achieved statistical significance in favor of A-101
45% Topical Solution versus vehicle and are described as
follows:
- Proportion of subjects with a single common wart whose wart is
clear at day 60 (p=0.0009); and
- Time for subjects to achieve clearance of all treated common
warts (p<0.0001).
In THWART-1, there were no treatment-related serious adverse
events (SAEs) in subjects treated with A-101 45%; however, 2
non-related treatment emergent SAEs were reported (an animal bite
in the A-101 45% group and a suicide attempt in the vehicle
group). The most common adverse events (AEs) occurring in
more than 5% of subjects in the A-101 45% group were application
site pain, scabbing, erythema, pruritus and erosion.
Treatment-related AEs were reported in 52.8% (34.6% mild, 17.3%
moderate and 0.8% severe) and 6% of the subjects in the A-101 45%
and vehicle groups, respectively. No subjects withdrew
because of AEs, but one subject in the A-101 45% group discontinued
treatment due to application site erythema and vesicles.
The safety data from THWART-1 trial was comparable to that of
the THWART-2 trial, which were previously reported in Aclaris’
September 16, 2019 press release.
“These results provide robust clinical evidence for the efficacy
and safety of A-101 45% and support its viability as a potential
treatment for common warts,” said Dr. David Gordon, Chief Medical
Officer of Aclaris. “These data will serve as the basis for an NDA
filing, and we believe A-101 45% will be of interest to partners
seeking to commercialize this drug candidate, which has the
potential to be the first FDA-approved prescription treatment for
common warts.”
Company to Host Conference Call
Management will conduct a conference call at 4:30 PM ET today to
review these Phase 3 results and related matters. The
conference call will be webcast live over the Internet and can be
accessed by logging on to the “Investors” page of the Aclaris
Therapeutics website, www.aclaristx.com, prior to the event. A
replay of the webcast will be archived on the Aclaris Therapeutics
website for 30 days following the call. A slide presentation will
accompany the conference call.
To participate on the live call, please dial (844) 776-7782
(domestic) or (661) 378-9535 (international), and reference
conference ID 9299384 prior to the start of the call.
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 19 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 patients with
immuno-inflammatory diseases who lack satisfactory treatment
options. The company’s diverse and multi-stage portfolio includes
one late-stage investigational drug candidate 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%, the potential NDA filing for A-101 45% and the potential
for partnerships for commercializing A-101 45%. 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.
Contact:
Aclaris ContactMichael Tung, M.D.Corporate Strategy/Investor
Relations484-329-2140mtung@aclaristx.com
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