Aclaris Therapeutics Submits Investigational New Drug Application for ATI-50001 to Treat Alopecia Universalis and Alopecia To...
October 31 2016 - 8:00AM
Aclaris Therapeutics, Inc. (NASDAQ:ACRS), today announced that it
has submitted an Investigational New Drug Application (IND) to the
U.S. Food and Drug Administration (FDA) for its drug candidate
ATI-50001 for the treatment of alopecia universalis and alopecia
totalis. Aclaris plans to conduct a human
pharmacokinetic/pharmacodynamic (pK/pD) study to evaluate the
safety of ATI-50001 in healthy volunteers.
“We are excited to have achieved this important milestone,” said
Dr. Stuart Shanler, Chief Scientific Officer. “We look
forward to developing ATI-50001 as a potential oral treatment for
these severe phenotypes of alopecia areata.”
Alopecia areata is an autoimmune disease characterized by
patchy, non-scarring hair loss on the scalp and body. The
scalp is the most commonly affected area, and the National Alopecia
Areata Foundation estimates that 6.8 million patients in the United
States have had or will develop alopecia areata during their
lives.1 The disease affects both women and men; two-thirds of
affected individuals are younger than 30 years old at the time of
onset of disease. Alopecia areata can be associated with
serious psychological consequences, including anxiety and
depression.2 A significant unmet need exists for a safe and
efficacious treatment.
Aclaris has exclusively licensed several patents and patent
applications involving novel selective Janus kinase (JAK) 1/3
inhibitors, including a patent portfolio from Rigel
Pharmaceuticals, Inc. that covers ATI-50001 as well as ATI-50002, a
topical formulation also being developed as a potential treatment
for alopecia areata. In addition, Aclaris has exclusively
licensed a patent portfolio from JAKPharm and Key Organics directed
to novel covalently binding, highly selective JAK 3
inhibitors. Finally, Aclaris has exclusively licensed a
patent portfolio from Columbia University directed to methods
of using JAK inhibitors for the treatment of alopecia areata,
androgenetic alopecia, and other dermatological conditions.
This portfolio includes a recently issued U.S. patent directed to
methods of treating alopecia areata, androgenetic alopecia and
other hair loss disorders by administering ruxolitinib, and a
recently issued patent in Japan directed to pharmaceutical
compositions comprising ruxolitinib, baricitinib or other JAK
inhibitors for use in treating alopecia areata, androgenetic
alopecia and other hair loss disorders.
1 National Alopecia Areata
Foundation, https://www.naaf.org/alopecia-areata. Last
accessed October 24, 2016.
2 Hunt, Nigel and McHale, Sue. The psychological impact of
alopecia. British Medical Journal. 2005 Oct 22;331:
951-3
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage specialty
pharmaceutical company focused on identifying, developing, and
commercializing innovative and differentiated drugs to address
significant unmet needs in dermatology. Aclaris is based in
Malvern, Pennsylvania and more information can be found by visiting
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’ development
programs in skin and hair conditions, and the clinical development
of JAK inhibitors. 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, 2015, Aclaris’ Quarterly Report on
Form 10-Q for the quarter ended June 30, 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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