Aclaris Therapeutics Announces Notice of Allowance for a U.S. Patent Application Covering Lead Candidate A-101 Topical Soluti...
April 26 2017 - 7:00AM
Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led,
biotechnology company focused on defining innovative therapies in
medical and aesthetic dermatology, today announced that it has
received a Notice of Allowance from the United States Patent and
Trademark Office (USPTO) for a patent application covering the
formulation and methods of use of A-101 40% topical solution (A-101
40%), an investigational drug, being developed by Aclaris for the
treatment of seborrheic keratosis (SK) and A-101 45% topical
solution (A-101 45%), an investigational drug, being developed by
Aclaris for the treatment of common warts (verruca vulgaris).
Aclaris submitted a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) for A-101 40% as a treatment for SK in
February 2017. In August 2016, Aclaris reported positive data
from a Phase 2 trial, WART-201, in which patients treated with
A-101 45% achieved statistically significant and clinically
meaningful improvement on all primary and secondary endpoints. This
newly allowed patent application contains 70 allowed claims and
expires in 2035.
“We are extremely pleased with this expansion of the patent
estate for A-101,” said Dr. Neal Walker, President and Chief
Executive Officer of Aclaris. “This allowance expands the breadth
of and further validates our A-101 intellectual property portfolio.
It covers both the A-101 40% and 45% topical solutions, along with
other high concentration hydrogen peroxide formulations and their
methods of treating SK and other dermatological conditions which
adversely impact how patients look, feel and live.”
Aclaris’ A-101 patent estate additionally includes other granted
U.S. and foreign patents and pending patent applications directed
to high concentration topical hydrogen peroxide formulations,
methods of use, and applicators, for the alleviation of skin
conditions including, among others, SK, common warts, molluscum
contagiosum, skin tags (acrochordons), and other dermatological
conditions.
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 with a
waxy, scaly, slightly elevated appearance that can vary in color
from light tan to dark brown or black. SK lesions frequently appear
in highly visible locations, such as the face or neck, and can have
an adverse physical and emotional impact on people who have them.
SK sufferers may be affected with just one lesion or dozens and
often have a family history of SK. Prevalence of SK increases with
advancing age and over three quarters of patients seeking treatment
from dermatologists are aged 40 to 69. SK is one of the most
frequent diagnoses made by dermatologists, yet it remains
undertreated. There are currently no FDA-approved medications for
SK, and existing treatment procedures are often painful, 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 based in Malvern,
Pennsylvania and more information can be found by visiting the
Aclaris website at www.aclaristx.com.
Cautionary Note Regarding Forward-Looking StatementsAny
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’ A-101 intellectual property portfolio.
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 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.
Contact:
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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