Aclaris Therapeutics Announces Positive 6-Month Results from Phase 2  Clinical Trial

Aclaris Therapeutics, Inc. 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.

The trial evaluated ATI-502 in women and men with AGA. Subjects aged 18-50 years (n=31) applied ATI-502 to their scalp twice daily for 26 weeks. Twenty-three subjects completed 6 months of treatment. Twenty subjects (14 male, 6 female) had evaluable hair counts, and twenty-two (15 male and 7 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.

The secondary endpoints included an IGA and SSA. Subjects who experienced increased hair growth were given a score of +1 or better on the IGA and SSA (+1 = slightly increased hair growth, +2 = moderately increased hair growth, and +3 = greatly increased hair growth). 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. There were no treatment-related serious adverse events. There was one unrelated serious adverse event of breast cancer reported, and one patient withdrew for treatment-related alopecia in week one.

“The combination of the TAHC data, the investigator and subject assessments, and our own internal review of the formal photography, suggest topical JAK inhibition is a viable approach to treating AGA,” said Dr. Neal Walker, President and CEO of Aclaris. “This finding demonstrates that inhibiting a non-hormonal and inflammatory-mediated pathway may be an option for the treatment of AGA.”

“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,” said Dr. Janet Roberts of Northwest Dermatology Institute, Portland, OR, a Principal Investigator in the clinical trial.

Next Steps:

• The 12-month results from this trial are expected by year end 2019.
• Through recent formulation work, Aclaris can achieve significantly higher topical concentrations of ATI-502.
• As such, Aclaris believes the next step is initiating a double-blind, randomized, controlled Phase 2 dose-ranging clinical trial with higher concentrations of ATI-502, with potentially a female focus, in the first half of 2020.

Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of people with immuno-inflammatory and dermatological diseases who lack satisfactory treatment options. The company’s diverse and multi-stage portfolio includes two FDA-approved medicines, one late-stage investigational medicine, and a pipeline powered by a robust R&D engine exploring protein kinase regulation. Aclaris Therapeutics’ active development programs focus on areas where significant treatment gaps exist, such as common warts, alopecia areata, and vitiligo. For more information, visit www.aclaristx.com.