Aclaris Therapeutics Announces Top-line Results from 4-Week Phase 2b Trial of ATI-1777 for Mild to Severe Atopic Dermatitis

- ATI-1777 2% BID Achieved a Statistically Significant Result in the Primary Efficacy Endpoint at Week 4 -

- Minimal Systemic Exposure Supports “Soft” Topical JAK Inhibitor Approach -

- ATI-1777 Was Well Tolerated -

WAYNE, Pa., Jan. 10, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced top-line results from its Phase 2b study of ATI-1777, an investigational topical “soft” JAK 1/3 inhibitor, in patients with mild to severe atopic dermatitis (AD) (ATI-1777-AD-202; NCT05432596). ATI-1777 was generated from Aclaris’ proprietary KINect drug discovery platform.

ATI-1777-AD-202 was a Phase 2b, multicenter, randomized, double-blind, vehicle-controlled, parallel-group clinical trial to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of multiple concentrations (0.5%, 1% and 2%) of twice daily treatment with ATI-1777 and a single concentration (2%) of once daily treatment with ATI-1777. For this trial, ATI-1777 was developed as an emollient-containing spray formulation. The trial randomized 250 patients with mild, moderate or severe AD, including adults and children as young as 12 years old, across 30 clinical trial sites in the United States.

“The trial demonstrated efficacy results, a pharmacokinetic profile and safety results that were consistent with what was seen in the Phase 2a trial of ATI-1777,” stated Dr. Neal Walker, Aclaris’ Chairman of the Board of Directors. “We are excited that ATI-1777 demonstrated response rates on par with existing market competition, along with a differentiated safety profile relative to JAK inhibitors given the low systemic absorption seen in both Phase 2 studies. These results are particularly encouraging given the higher than anticipated vehicle response and the mid-study inclusion of a milder patient population. The convenience of a spray formulation along with the potential to move to once-a-day dosing, potentially offer additional distinct advantages to patients suffering from atopic dermatitis.”

Results
The trial met the primary efficacy endpoint, the percent change from baseline in the Eczema Area and Severity Index (EASI) score at week 4, with statistical significance for patients treated with ATI-1777 2% BID compared to patients treated with vehicle (69.7% versus 58.7% in the pooled vehicle group, p=0.035). In addition, the following results were observed with respect to the primary endpoint: