WAYNE, PA, USA I April 23, 2018 I Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, today announced the initiation of a Phase 2 open-label study of ATI-502, a topical Janus Kinase (JAK) 1/3 inhibitor (ATI-502 Topical), in patients with androgenetic alopecia (AGA), a condition characterized by a genetically determined male/female-pattern baldness. 

This trial will evaluate the safety, tolerability and effect of ATI-502 Topical applied twice daily in 24 adult subjects (12 male, and 12 female) with androgenetic alopecia.  This 30-week trial will be conducted at 3 investigational centers within the United States.

JAK signaling has been implicated in maintaining the hair cycle in its resting phase (telogen) in mice. Treatment of mouse telogen skin with topical JAK inhibitors prompts telogen follicles to enter the active growth phase (anagen). Hair loss disorders, such as AGA, in which the hair follicles are arrested in telogen phase, may be responsive to treatment with topical JAK inhibitors to promote their entry into anagen, and thus result in the initiation of hair growth.1

 “This trial is the first step in evaluating the potential clinical benefit of ATI-502 topical solution in treating patients with AGA, or male/female pattern baldness,” said Dr. Stuart Shanler, Chief Scientific Officer of Aclaris. “This is an important step forward in understanding the clinical utility of our JAK inhibitors in patients with AGA.”

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 dermatology, both aesthetic and medical, and immunology. Aclaris’ focus on market segments with no FDA-approved medications or where treatment gaps exist has resulted in the first FDA-approved treatment for raised seborrheic keratoses and several clinical programs to develop medications for the potential treatment of common warts, alopecia areata, and vitiligo. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn.

About Androgenetic Alopecia

Androgenetic alopecia (AGA), also known as male pattern baldness or female pattern hair loss, is the most common form of hair loss.2 The condition may affect up to 70% of men and 40% of women, beginning at some point in their adult lives.3 Male pattern baldness usually involves hairline recession and balding of the highest point of the head, while female pattern hair loss tends to manifest as thinning hair over the top of the scalp. Susceptibility to AGA is largely determined by genetics, though environmental factors may play a minor role. Affected individuals can be highly motivated to seek treatment, due to negative image perceptions.3 Currently available treatment procedures and medications are not optimal for some patients for various reasons, such as adverse reactions and contraindications. There is an unmet need for an additional safe and effective treatment option for AGA.

1 S. Harel, C. A. Higgins, J. E. Cerise, Z. Dai, J. C. Chen, R. Clynes, A. M. Christiano, Pharmacologic inhibition of JAK-STAT signaling promotes hair growth. Sci. Adv. 1, e1500973 (2015).

2 Ghanaat M, Types of Hair Loss and Treatment Options. South Med J. 2010;103(9):917-921.

3 http://www.skintherapyletter.com/alopecia/promising-therapies/. Last accessed April 9, 2018.

SOURCE: Aclaris Therapeutics