How Aclaris Is On Track to Treat Baldness

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.

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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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