Aclaris Therapeutics Completes Enrollment for Phase 2b Trial of ATI-1777 in Atopic Dermatitis

Aclaris Therapeutics, a clinical-stage biopharmaceutical company, has announced the successful completion of enrollment for its Phase 2b trial of ATI-1777, an investigational topical “soft” Janus kinase (JAK) 1/3 inhibitor. The trial focuses on patients with mild to severe atopic dermatitis, a common inflammatory skin condition.

The company expects to release top-line efficacy, safety, and other preliminary data from this trial by the end of the year. This achievement marks a significant milestone for Aclaris, positioning them for an exciting year-end with the data read-out of their Phase 2b trial of zunsemetinib (ATI-450) in rheumatoid arthritis expected in November.

ATI-1777 is a topical JAK inhibitor designed to minimize systemic exposure and is delivered in a convenient spray-on solution. The Phase 2b trial builds upon the positive results observed in the Phase 2a trial, which demonstrated meaningful improvement in the modified Eczema Area and Severity Index (EASI) and minimal measurable systemic exposure with a 2% formulation applied twice daily.

The Phase 2b trial will explore different concentration ranges (0.5%, 1%, and 2%) and a once-daily regimen using the 2% formulation. It enrolled 250 patients with mild, moderate, or severe atopic dermatitis, including adults and children as young as 12 years old, across 34 clinical trial sites in the United States.

The primary efficacy endpoint of the trial is the percent change in EASI over a period of four weeks. Secondary measures of efficacy, as well as safety and pharmacokinetics, will also be assessed.

Dr. Gail Cawkwell, Aclaris’ Chief Medical Officer, expressed her satisfaction with the completion of enrollment for the Phase 2b trial, highlighting the potential of ATI-1777 in treating atopic dermatitis. Aclaris aims to develop ATI-1777 as an emollient-containing spray formulation to address the unmet needs of patients with mild to severe atopic dermatitis.

Aclaris Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative drug candidates for patients with immuno-inflammatory diseases. Their pipeline of novel drug candidates is powered by a robust research and development engine focused on protein kinase regulation.

For more information about Aclaris Therapeutics and their ongoing research, please visit www.aclaristx.com.

Please note that ATI-1777 is currently in clinical development, and its safety and efficacy have not been evaluated by regulatory authorities.

Contact:
Robert A. Doody Jr.
Vice President, Investor Relations
484-639-7235
rdoody@aclaristx.com