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Aclaris Therapeutics Initiates Phase 2 Trial of Bosakitug (ATI-045) in Atopic Dermatitis

Core Insights - Aclaris Therapeutics has initiated a Phase 2 trial for bosakitug, an investigational monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), in patients with moderate-to-severe atopic dermatitis (AD) [1][2] - The trial aims to evaluate the efficacy and safety of bosakitug, with top line results expected in the second half of 2026 [1][2] Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases [7] - The company has a robust R&D engine and a multi-stage portfolio of product candidates [7] Product Details - Bosakitug (ATI-045) is a humanized anti-TSLP monoclonal antibody that blocks TSLP's interaction with its receptor, preventing the release of proinflammatory cytokines [3] - It exhibits high affinity, potency, and a long residence time, potentially allowing for extended dosing intervals [3] Clinical Trial Information - The Phase 2 trial is randomized, double-blind, and placebo-controlled, involving approximately 90 patients [2] - Primary endpoint is the percent change in Eczema Area and Severity Index (EASI) at week 24, with secondary endpoints including various EASI responses and safety assessments [2] Atopic Dermatitis Context - Atopic dermatitis affects approximately 10 million children and 17 million adults in the U.S., with over 200 million affected worldwide [5] - The condition significantly impacts quality of life, with many patients experiencing moderate to severe symptoms [5] TSLP Significance - TSLP is a key cytokine in the Type 2 immune response, driving inflammation in allergic and inflammatory diseases [4] - It activates downstream targets involved in the inflammatory cascade, making it a relevant therapeutic target [4]