FDA Accepts Aclaris Therapeutics’ New Drug Application for Topical Treatment of Seborrheic Keratosis, a Common Skin Conditi...
May 09 2017 - 4:05PM
Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led
biotechnology company, today announced that the U.S. Food and Drug
Administration has accepted its New Drug Application (NDA) A-101
40% topical solution (A-101 40%), an investigational drug, for the
potential treatment of seborrheic keratosis (SK), a common skin
condition.
The NDA acceptance by the FDA in its 74-day letter indicates
that the application is sufficiently complete to permit a
substantive review. The PDUFA target action date for the completion
of the FDA’s review of the NDA is December 24, 2017. If approved,
A-101 40% would be the first FDA-approved topical medication for
the treatment of SK.
“The FDA’s acceptance of our NDA for A-101 40% is a significant
achievement that brings Aclaris one step closer to providing an
innovative treatment option for SK patients and the physicians who
treat the condition,” said Christopher Powala, Chief Operating
Officer of Aclaris. “There is a significant need for a
non-invasive, topical SK treatment as SK often appears in highly
visible locations like the face and neck and can adversely affect
patients’ emotional well-being.”
About A-101A-101 40% topical solution, an
investigational drug, is a proprietary, high-concentration hydrogen
peroxide formulation for the treatment of seborrheic keratosis
(SK). It is being developed as a non-invasive, in-office treatment
administered by physicians or other licensed health care
professionals. In clinical trials, patients treated with
A-101 40% achieved statistically and clinically significant
improvement in clearing SK lesions compared to placebo and with a
similar adverse event profile. A-101 40% is designed to work by
penetrating into the SK lesion and causing oxidative damage, which
can ultimately result in the sloughing of the SK cells. A-101
40% has been the focus of a robust clinical development program in
which over 700 patients have been treated with A-101. The 45%
concentration of A-101 is also in clinical development for the
treatment of common warts (verruca vulgaris).
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. There are currently 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 biotechnology company
focused on identifying, developing and commercializing innovative
and differentiated therapies to address significant unmet needs in
medical and aesthetic dermatology. Aclaris is focused on
large, 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 (SK
only press releases)
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 of A-101 for
the treatment of SK. 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, risks associated with maintaining its intellectual
property portfolio and other risks and uncertainties that are
described in Aclaris’ Annual Report on Form 10-K for the year ended
December 31, 2016 and other filings Aclaris makes with the SEC 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 Contact
Michael Tung, M.D.
Investor Relations
484-329-2140
mtung@aclaristx.com
Media Contact
Mariann Caprino
TogoRun
917-242-1087
M.Caprino@togorun.com
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