Aclaris Therapeutics Announces Publication of Data from Phase 2 Clinical Trial of A-101 Topical Solution for Treatment of Fac...
September 19 2017 - 08:00AM
Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led
biopharmaceutical company, today announced that results from a
Phase 2 clinical trial evaluating two concentrations (40% and
32.5%) of its drug candidate A-101 for the treatment of facial
seborrheic keratosis (SK) lesions have been published in the
journal Dermatologic Surgery. A-101 is an investigational,
proprietary, high-concentration hydrogen peroxide-based topical
solution that Aclaris is developing as a potential treatment for
SK. In the trial, A-101 achieved statistical significance in
clearing SK lesions on the face in a dose-related fashion. A-101
was well tolerated at both concentrations studied. The FDA’s
Prescription Drug User Fee Act (PDUFA) action date for the New Drug
Application (NDA) is December 24, 2017. If approved, A-101 40%
would be the first FDA-approved medication for SK.
SK is a common skin condition affecting more than 83 million
Americans. It is characterized by non-cancerous lesions varying in
color from light tan to dark brown or black. SK lesions may be
cosmetically worrisome to patients, particularly when they appear
on the face. In a survey of 10 dermatologists evaluating their own
SK patients (n=406), 80% of patients had SK lesions on their face
or neck.
In the randomized, double-blind, vehicle-controlled Phase 2
trial to evaluate A-101 topical treatment for facial SK lesions,
the 40% and 32.5% concentrations were each compared to vehicle
(placebo) in a total of 119 patients. Greater magnitude of effect
was observed with the A-101 40% concentration than the 32.5%
concentration when each was compared to vehicle. At day 106, the
target lesion was clear or near clear in 68% of patients in the
A-101 40% group, 62% of patients in the A-101 32.5% group, and 5%
of patients in the vehicle group. Improvements compared to vehicle
were seen after just one treatment, but most patients received a
second treatment in accordance with the study protocol.
“These data suggest that A-101 40%, if approved, may be an
appealing treatment option for dermatologists and their patients
who wish to remove SK lesions in highly visible areas, such as the
face, with minimal risk of scarring or hypopigmentation,” said
Aclaris Chief Scientific Officer Stuart D. Shanler, M.D.
In the Phase 2 trial, A-101 solution had a favorable safety and
tolerability profile at both concentrations. There were no
treatment-related adverse events among patients treated with A-101.
Local skin reactions were predominantly classified as mild and
transient. No patients had scarring or hypopigmentation at the end
of the trial.
“Sometimes dermatologists determine that the risk of a poor
cosmetic outcome is too great in the risk-benefit equation for
treatment of SK,” said Dr. Neal Walker, President and Chief
Executive Officer of Aclaris. “We are pleased with the results from
this study, which highlight the potential of A-101 40% to meet a
significant unmet need for a topical, non-invasive treatment for
SK.”
About A-101 A-101 40% topical solution, an
investigational drug, is a proprietary, high-concentration hydrogen
peroxide formulation for the potential treatment of seborrheic
keratosis (SK). It is being developed as a non-invasive, in-office
treatment administered by physicians or other health care
professionals. A 45% concentration of A-101 is also in clinical
development for the treatment of verruca vulgaris (common
warts).
About Seborrheic Keratosis Seborrheic keratosis
(SK) is a skin condition that affects more than 83 million
Americans and is characterized by non-cancerous lesions varying in
color from light tan to dark brown or black. SK lesions range in
size from a millimeter to a few centimeters wide and usually have a
slightly elevated, waxy, scaly appearance. People with SK may be
affected with just one lesion or dozens and often have a family
history of SK. SK lesions can appear anywhere on the body, except
the palms, soles and mucous membranes, and frequently appear in
highly visible locations, such as the face or neck. Though the
lesions usually do not cause physical discomfort, SK can adversely
affect the appearance and emotional well-being of people who have
it. Prevalence of SK increases with advancing age and the majority
of patients seeking treatment from dermatologists are between 40
and 70 years of age. Fewer than 10% of people with SK receive
treatment, though it is one of the most frequent diagnoses made by
dermatologists. Currently, there are no FDA-approved medications
for SK, and existing treatment procedures are often painful or
invasive and can have undesirable outcomes like scarring or
dyspigmentation.
About Aclaris
Therapeutics, Inc. Aclaris Therapeutics, Inc. is a
dermatologist-led biopharmaceutical company focused on identifying,
developing and commercializing innovative therapies to address
significant unmet needs in medical and aesthetic dermatology.
Aclaris is focused on underserved market segments with
no FDA-approved medications or where treatment gaps exist.
Aclaris is based in Malvern, Pennsylvania and more
information can be found by visiting the Aclaris website at
www.aclaristx.com.
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 Aclaris’ clinical
development and potential regulatory approval for A-101
40%. 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, 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, 2016, Aclaris’ Quarterly Report on Form
10-Q for the quarter ended June 30, 2017, and other filings
Aclaris makes with the U.S. Securities and Exchange
Commission from time to time. These documents are available
under the “Financial Information” 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.Investor
Relations484-329-2140mtung@aclaristx.com
Media ContactMariann
CaprinoTogoRun917-242-1087M.Caprino@togorun.com
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