Aclaris Therapeutics Announces Notice of Allowance for Two U.S. Patent Applications Covering Baricitnib and Decernotinib, Respectively, for Hair Loss Disorders

MALVERN, Pa., April 04, 2017 -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led, biotechnology company focused on defining new standards of care in medical and aesthetic dermatology, today announced that Columbia University has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for two patent applications covering methods related to the use and administration of baricitinib (LY3009104) and decernotinib (VX-509), respectively, for the treatment of hair loss disorders and for inducing hair growth. These newly allowed patent applications are owned by The Trustees of Columbia University in the City of New York and exclusively licensed to Aclaris Therapeutics, Inc. These patent applications are the latest U.S. applications to be allowed in connection with Aclaris' janus kinase inhibitor (JAK) drug development program for hair loss disorders. A separate Columbia patent covering the use of ruxolitinib for the treatment of hair loss disorders and for inducing hair growth was issued in the U.S. in December 2015. 

“We are extremely pleased with this expansion of the patent portfolio we exclusively licensed from Columbia.  These allowances expand the breadth of and further validate our JAK inhibitor intellectual property portfolio covering methods of use for certain JAK inhibitors for the treatment of hair loss disorders. The allowance of these patent applications is another step towards the development of a robust portfolio relating to JAK inhibition and hair loss,” said Dr. Neal Walker, President and Chief Executive Officer of Aclaris.

The claims of these newly allowed patent applications cover methods of inducing hair growth and treating various hair loss disorders, including alopecia areata and androgenetic alopecia, by administering baricitinib or decernotinib, respectively.  Additional allowed claims pertain to methods of using baricitinib or decernotinib to treat other hair loss disorders, as well as to treat particular phenotypes of alopecia areata.

Aclaris has exclusively licensed several patents and patent applications involving novel selective 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 the recently allowed U.S. applications discussed above, 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.

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.

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 our JAK inhibitor 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
[email protected]

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