WAYNE, PA — Aclaris Therapeutics Inc. (Nasdaq: ACRS) said it has initiated a randomized, placebo-controlled Phase 1b proof-of-concept trial of its investigational antibody ATI-052 in patients with asthma, as it advances development of the drug candidate for immuno-inflammatory diseases.
The clinical-stage biopharmaceutical company said the trial follows the recent start of a separate Phase 1b proof-of-concept study of ATI-052 in atopic dermatitis. Aclaris said it plans to launch a Phase 2b program in the second half of 2026 evaluating asthma and atopic dermatitis as initial indications.
The Phase 1b asthma study is a randomized (3:1), double-blind, placebo-controlled trial expected to enroll approximately 16 patients who are on Global Initiative for Asthma steps 2-4 treatment prior to screening. The study will evaluate safety, tolerability and efficacy compared with placebo.
Endpoints include safety and tolerability measures, pharmacokinetics and pharmacodynamic biomarkers such as fractional exhaled nitric oxide and blood eosinophil counts, as well as lung function measured by forced expiratory volume in one second.
“The positive Phase 1a interim results for ATI-052 exceeded our expectations and demonstrated a strong safety and tolerability profile, extended pharmacokinetics, and concentration-dependent pharmacodynamics even at the lowest dose,” Jesse Hall, chief medical officer of Aclaris, said in a statement. He said the company expects to report topline results from both Phase 1b trials in the second half of 2026.
ATI-052 is a humanized bispecific antibody designed to inhibit thymic stromal lymphopoietin and interleukin-4 receptor alpha, two targets involved in inflammatory and allergic pathways. Aclaris said it holds exclusive worldwide rights to ATI-052, excluding Greater China.
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