Aclaris Therapeutics has begun a randomized, placebo‑controlled Phase 1b study of its bispecific anti‑TSLP/IL‑4Rα antibody ATI‑052 in patients with moderate‑to‑severe atopic dermatitis. The trial will enroll participants in a 3:1 randomization scheme and will evaluate safety, tolerability, and clinical efficacy using the Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA) response, and Peak Pruritus Numerical Rating Scale (PP‑NRS) as primary endpoints.
ATI‑052 combines TSLP inhibition with IL‑4Rα blockade, targeting two key drivers of Th2‑mediated inflammation. This dual mechanism is designed to provide broader disease control while limiting systemic exposure, potentially offering a more effective and convenient treatment option compared with existing single‑target biologics such as dupilumab. The bispecific approach is a differentiator that could position ATI‑052 as a best‑in‑class therapy for atopic dermatitis and other Th2‑driven diseases.
Top‑line data from the atopic dermatitis study are expected in the second half of 2026, and a parallel Phase 1b study in asthma is slated to begin in the first quarter of 2026. Aclaris’s strategy to advance ATI‑052 across multiple indications underscores its commitment to a diversified pipeline and a broader therapeutic impact.
Chief Medical Officer Dr. Jesse Hall said the company is experiencing strong momentum in the ATI‑052 program, citing the positive Phase 1a interim results that demonstrated a favorable safety profile and concentration‑dependent pharmacodynamics. He added that the initiation of the Phase 1b trial marks a critical step toward validating the bispecific approach in patients.
Aclaris has disclosed a cash balance that supports a runway through the second half of 2028, giving the company ample time to complete the current and upcoming studies. The company’s inclusion in the Nasdaq Biotechnology Index reflects its growing stature in the biotech sector.
While the announcement is a milestone, analysts remain positive about the company’s trajectory, maintaining buy ratings and noting the potential upside from ATI‑052’s dual‑target mechanism and the company’s strong financial footing.
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