Aclaris Therapeutics, Inc. (ACRS) says its first-in-human study of ATI-052 exceeded the company's target profile, delivering full top-line results that support the potential for extended dosing and broad activity across inflammatory pathways.
ATI-052 is a novel bispecific antibody designed to block both TSLP and IL-4Ra - two key drivers of Th2-mediated inflammation. In the Phase 1a single- and multiple-ascending dose study in healthy volunteers, the drug showed a favorable safety profile, dose-proportional pharmacokinetics, and sustained pharmacodynamic activity. According to the company, ATI-052 achieved complete and prolonged inhibition of TSLP- and IL-4 induced signaling, with an estimated half-life of approximately 45 days, supporting the potential for once-every-three-months dosing.
The Phase 1a trial enrolled healthy adults who received either single or multiple subcutaneous doses of ATI-052 or placebo. Participants were followed for up to 20 weeks depending on the cohort. No safety signals were observed, including no cases of conjunctivitis, and no impact of anti-drug antibodies on drug exposure or activity was reported.
Aclaris is now advancing ATI-052 into two ongoing Phase 1b proof-of-concept studies in asthma and atopic dermatitis, with top-line results expected in the second half of 2026. The company also plans to initiate a Phase 2b program in asthma in the fourth quarter of 2026.
Alongside the ATI-052 update, Aclaris announced lichen planus (LP) as the lead indication for ATI-2138, its oral ITK/JAK3 inhibitor. LP is a chronic inflammatory skin and mucosal disease with no FDA-approved treatments. ATI-2138 is designed to suppress pathogenic T-cell activity by targeting both TCR signaling and cytokine-driven activation. Aclaris intends to launch a multi-part Phase 2b basket study in the second half of 2026, initially focusing on erosive mucosal and cutaneous LP, followed by lichen planopilaris.
ACRS has traded between $1.16 and $4.89 over the past year. The stock closed Monday's trading at $4.41, up 2.56%. In pre-market trading, the stock trading at $4.16, down 5.52%.
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