Aclaris Therapeutics announced positive full top-line results from a first-in-human Phase 1a clinical trial of ATI-052, a bispecific antibody targeting thymic stromal lymphopoietin (TSLP) and interleukin-4 receptor alpha (IL‑4Rα). The Phase 1a study was conducted in healthy volunteers and evaluated single ascending doses up to 720 mg and multiple weekly doses up to 480 mg. According to the company, ATI‑052 demonstrated a favorable safety, pharmacokinetic, and pharmacodynamic profile, with dose-proportional pharmacokinetics and an estimated half-life of approximately 45 days.
The pharmacokinetic data from the Phase 1a trial support the potential for ATI‑052 dosing as infrequently as once every three months. Aclaris is currently enrolling Phase 1b proof-of-concept trials of ATI‑052 in asthma and atopic dermatitis. Top-line data from these Phase 1b studies are expected in the second half of 2026, and the company plans to initiate a Phase 2b asthma program in the fourth quarter of 2026.
In the same update, Aclaris reported that it has selected lichen planus (LP) as the lead indication for its oral ITK/JAK3 inhibitor ATI‑2138. The company plans a multi-part Phase 2b basket trial in LP subtypes, including erosive mucosal, cutaneous, and lichen planopilaris forms, beginning in the second half of 2026. Aclaris has estimated a potential U.S. market opportunity above $1.0 billion and up to $4.0 billion for an oral therapy in lichen planus.
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