Press Release

Aclaris Therapeutics Announces Issuance of U.S. Patent Covering a JAK Inhibitor for Treating Hair Loss Disorders
March 9, 2018

Issuance of U.S. Patent No. 9,895,301 Further Bolsters Aclaris’ Intellectual Patent Portfolio

WAYNE, Pa., March 09, 2018 (GLOBE NEWSWIRE) -- 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 the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 9,895,301, which is directed to methods related to the use and administration of a certain janus kinase (JAK) inhibitor for treating hair loss disorders. 

U.S. Patent No. 9,895,301 covers the use of tofacitinib for inducing hair growth and for treating hair loss disorders such as alopecia areata and androgenetic alopecia (AGA), otherwise known as  male/female pattern hair loss.  Additional issued claims pertain to methods of using tofacitinib to treat particular phenotypes of alopecia areata, as well as to treat other hair loss disorders. The ‘301 Patent contains 67 claims and expires in November 2031. 

This newly allowed patent is owned by The Trustees of Columbia University in the City of New York and exclusively licensed to Aclaris and is the latest U.S. patent to issue in connection with Aclaris' JAK drug development program for hair loss disorders.

“We are extremely pleased with the continued development of the patent portfolio we exclusively licensed from Columbia.  This new issuance continues to expand the breadth and depth of our JAK inhibitor intellectual property portfolio covering methods of use for certain JAK inhibitors for the treatment of hair loss disorders. The issuance of this patent is another step in the development of a robust patent portfolio relating to JAK inhibition and hair loss,” said Dr. Neal Walker, President and Chief Executive Officer of Aclaris.

Aclaris has exclusively licensed several patents and patent applications involving novel selective JAK 1/3 inhibitors, including a patent portfolio that covers Aclaris’ product candidates ATI-501 (formerly  ATI-50001) and ATI-502 (formerly ATI-50002), which are oral and topical formulations, respectively, also being developed as potential treatments for alopecia areata.  In addition,  Aclaris has exclusively licensed a patent portfolio from Columbia University directed to methods of using JAK inhibitors for the treatment of alopecia areata, AGA, and other dermatological conditions.  This portfolio includes the recently issued U.S. patent discussed above, as well as issued U.S. patents directed to methods of treating alopecia areata, AGA and other hair loss disorders by administering ruxolitinib, baricitinib, or decernotinib, and issued patent claims in Japan directed to pharmaceutical compositions comprising ruxolitinib, baricitinib, tofacitinib or other JAK inhibitors for use in treating alopecia areata, AGA and other hair loss disorders.

About Aclaris Therapeutics, Inc.

Aclaris Therapeutics, Inc. is a dermatologist-led biopharmaceutical company committed to identifying, developing and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunodermatology. Aclaris is focused on market segments with no FDA-approved medications or where treatment gaps exist. Aclaris is based in Wayne, Pennsylvania. 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 development of Aclaris’ product candidates focused on JAK inhibition for the treatment of hair loss disorders, including 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, Aclaris’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, 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.
Senior Vice President
Corporate Strategy/Investor Relations
484-329-2140
mtung@aclaristx.com

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Source: Aclaris Therapeutics, Inc.