How Aclaris Is On Track to Treat Baldness

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Baldness and hair thinning is something that many men and women fear as they age, and understandably so. But Aclaris Therapeutics, Inc. (NASDAQ: ACRS) may have found an answer to the problem in its most recent mid-stage clinical trial.

The firm recently announced positive results from a Phase 2 open-label clinical trial of ATI-502 (AGA-201), an investigational topical Janus Kinase (JAK) 1/3 inhibitor, in patients with androgenetic alopecia (AGA), a condition commonly known as male/female-pattern baldness.

Overall, the trial evaluated a total of 31 women and men with AGA. Twenty-three subjects completed six months of treatment. Twenty subjects (14 male, 6 female) had evaluable hair counts, and 22 (15 male and seven female) recorded investigator global assessment (IGA) and subject self-assessment (SSA) scores.

The primary endpoint was the mean change from baseline in non-vellus target area hair count (TAHC) at Week 26.  The overall change was an increase of 8.6 hairs/cm2. TAHC increase was 15.3 hairs/cm2 in female subjects and 5.6 hairs/cm2 in male subjects.

Based on these endpoints, investigators rated 73% of subjects (16/22) as experiencing increased hair growth, and 82% of subjects (18/22) rated themselves as experiencing increased hair growth. ATI-502 was well-tolerated.

Janet L. Roberts, M.D,. of Northwest Dermatology Institute, Portland, Oregon, a principal investigator in the clinical trial, commented:

There has been no novel drug approved for the treatment of AGA for decades. These data are encouraging and suggest ATI-502 may be a potential treatment for patients with AGA – especially women.

Shares of Aclaris were last seen up about 3.6% at $4.84, with a 52-week range of $4.26 to $21.96.

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