Aclaris Therapeutics initiates Phase 1b PoC trial of ATI-052

Aclaris Therapeutics (ACRS) has initiated a placebo-controlled Phase 1b proof-of-concept trial of ATI-052, the Company’s potential best-in-class investigational bispecific anti-TSLP/IL-4Ralpha antibody, in asthma. This announcement follows the recent initiation of the Company’s Phase 1b POC trial of ATI-052 in atopic dermatitis. Planning is ongoing for a Phase 2b program encompassing asthma and atopic dermatitis as potential first indications. The Company expects to initiate this program in the second half of 2026. The randomized, double-blind, placebo-controlled Phase 1b POC trial will evaluate the safety, tolerability, and efficacy of ATI-052 compared to placebo in approximately 16 patients with asthma on GINA steps 2-4 treatment prior to screening. Endpoints that will be assessed include safety and tolerability parameters; pharmacokinetic parameters; respiratory pharmacodynamic biomarker assessments including FeNO; blood PD biomarker assessments including blood eosinophil count and endogenous cytokines/chemokines and inflammation markers in plasma/serum; and efficacy measures including FEV1. Top line results from this trial and the ongoing Phase 1b POC trial in AD are expected in the second half of 2026.