WAYNE, PA — Aclaris Therapeutics Inc. (NASDAQ: ACRS) said positive interim data from its first-in-human study of ATI-052 are accelerating the experimental drug’s push toward later-stage trials, signaling what the company believes could be a best-in-class treatment for inflammatory and immunological diseases.
The Wayne-based biotechnology company reported that its Phase 1a single and multiple ascending dose trial showed ATI-052 was well tolerated, demonstrated dose-proportional pharmacokinetics, and delivered strong, sustained pharmacodynamic effects even at low doses. The findings reinforce the potential for extended dosing intervals of up to once every three months, a feature that could differentiate the drug in crowded markets such as atopic dermatitis and asthma.
ATI-052 is a bispecific antibody designed to target both thymic stromal lymphopoietin and the interleukin-4 receptor alpha pathway, two key drivers of inflammation. Aclaris said the trial results exceeded internal expectations and validate the compound’s potency profile.
The randomized, blinded, placebo-controlled Phase 1a study enrolled healthy adult volunteers and evaluated subcutaneous doses ranging from 30 milligrams to 720 milligrams. Across all cohorts, treatment-emergent adverse events were mostly mild, with no serious adverse events or study discontinuations reported. Injection-site redness was the most common side effect and resolved without intervention. Notably, no cases of conjunctivitis were observed.
From a pharmacokinetic standpoint, ATI-052 demonstrated an effective half-life of at least 26 days, with approximately dose-proportional increases in peak concentration and overall exposure. Pharmacodynamic data showed robust target engagement, including near-complete inhibition of IL-4 and TSLP-stimulated inflammatory markers at relatively low doses. Higher doses produced sustained inhibition lasting several weeks, supporting the company’s confidence in extended dosing schedules.
Buoyed by the interim data, Aclaris said it expects to begin Phase 1b proof-of-concept trials in atopic dermatitis and asthma in the first quarter of 2026. Top-line results from those studies are anticipated in the second half of the year. Planning is also underway for a Phase 2b trial in atopic dermatitis, targeted for initiation later in 2026.
For Aclaris, the momentum around ATI-052 comes as the company looks to sharpen its clinical focus and demonstrate meaningful differentiation in immune-mediated diseases, where durability of response and patient convenience increasingly shape commercial outcomes.
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