Aclaris Therapeutics Submits Investigational New Drug Application for ATI-50002 to Treat Alopecia Areata

MALVERN, Pa., Aug. 02, 2017 -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led, biopharmaceutical company focused on identifying, developing and commercializing innovative and differentiated therapies to address significant unmet needs in medical and aesthetic dermatology, today announced that it has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for ATI-50002, a topical Janus Kinase (JAK) 1/3 inhibitor, for the treatment of patchy alopecia areata (AA). Aclaris expects to initiate two Phase 2 clinical trials of ATI-50002 in the second half of 2017.  These trials will be conducted at multiple investigational centers across the United States. 

“We are very pleased to have this IND under review by the FDA,” said Dr. Neal Walker, President & Chief Executive Officer of Aclaris. “We look forward to beginning the development of ATI-50002 as a potential topical treatment for AA.”

Through exclusive licenses, Aclaris has built an extensive intellectual property estate consisting of selective JAK 1/3 compounds, highly selective JAK 3 compounds, and methods of using JAK inhibitors to treat AA, androgenetic alopecia (AGA), and various other hair loss disorders. This portfolio includes a recently issued U.S. patent and recently allowed U.S. applications directed to methods of treating AA, AGA and other hair loss disorders by administering ruxolitinib, baricitinib or decernotinib, and a recently issued patent in Japan directed to pharmaceutical compositions comprising ruxolitinib or baricitinib for use in treating AA, AGA and other hair loss disorders. Aclaris intends to prosecute additional patents and patent applications worldwide to expand its intellectual property portfolio.

About Alopecia Areata
Alopecia areata is an autoimmune disease that results in partial or complete loss of hair on the scalp and body. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. AA can be associated with serious psychological consequences, including anxiety and depression. AA affects up to 2.0% of people globally at some point during their lifetime (i.e. incidence) and up to 0.2% of people are affected at any given time (i.e. prevalence). There are currently no drugs approved by the FDA for the treatment of AA.

About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a dermatologist-led biopharmaceutical 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 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 clinical development of ATI-50002 and Aclaris’ intellectual property strategy. 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.

Contact:

Aclaris Contact
Michael Tung, M.D. 
Investor Relations
484-329-2140
[email protected]

Media Contact
Mariann Caprino
TogoRun
917-242-1087
[email protected]