MALVERN, PA, USA I August 02, 2017 I 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

SOURCE: Aclaris Therapeutics