Aclaris Therapeutics Provides Corporate Update

- ATI-1777 Phase 2a Trial Results Published in JID Innovations -
- ATI-1777 Phase 2b Trial Topline Data Anticipated in January 2024 -
- Aclaris Announces Reduction in Workforce -

WAYNE, Pa., Dec. 19, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drugs for immuno-inflammatory diseases, today announced several corporate updates.

First, Aclaris announced the publication of the Phase 2a trial results of ATI-1777 in moderate to severe atopic dermatitis (AD) in the peer-reviewed journal JID Innovations on November 27, 2023. ATI-1777 is Aclaris’ investigational topical “soft” JAK 1/3 inhibitor being developed as a potential treatment for mild to severe AD that was generated from its proprietary KINect drug discovery platform.

The article, entitled “ATI-1777 a topical JAK 1/3 inhibitor may benefit atopic dermatitis without systemic drug exposure, results from preclinical development and Phase 2a randomized-controlled study ATI-1777-AD-201,” presents the results from both preclinical development studies and the Phase 2a study of ATI-1777 in moderate to severe AD, and is available here.

In the Phase 2a study, ATI-1777 demonstrated meaningful improvement in the modified Eczema Area and Severity Index (EASI) over 4 weeks of treatment and minimal measurable systemic exposure with a 2% formulation applied twice daily.

Based on these results, Aclaris progressed ATI-1777 into a Phase 2b trial in patients with mild to severe AD. The Phase 2b vehicle-controlled trial is designed to further explore the concentration range (0.5%, 1%, and 2%) of ATI-1777, as well as a once-daily regimen using the 2% formulation. The trial enrolled 250 patients, including adults and children as young as 12 years old, across 34 clinical trial sites in the United States. The primary efficacy endpoint is the percent change in EASI over a period of 4 weeks. Secondary measures of efficacy, as well as safety and pharmacokinetics, will also be assessed. Aclaris now expects to report top-line results from this trial in January 2024.

“We are excited by the recent publication of our ATI-1777 Phase 2a trial in JID Innovations, particularly with our top-line results from the Phase 2b trial expected early next year,” stated Douglas Manion, M.D., Aclaris’ Chief Executive Officer. “If the results of the Phase 2b trial are positive, we intend to seek a commercialization partner for the asset.”