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Aclaris Therapeutics Initiates Phase 2 Trial of Bosakitug (ATI-045) in Atopic Dermatitis
- Bosakitug is a Potential Best-in-Class Investigational Monoclonal Antibody with Demonstrated Superior Potency, Residence Time, and Affinity to Thymic
About this update from Aclaris Therapeutics, Inc.
[{"type":"text","content":"- Bosakitug is a Potential Best-in-Class Investigational Monoclonal Antibody with Demonstrated Superior Potency, Residence Time, and Affinity to Thymic Stromal Lymphopoietin (TSLP) - - Top Line Results Expected in the Second Half of 2026 - WAYNE, Pa., June 02, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that it has initiated a randomized, double-blind, placebo-controlled Phase 2 trial of bosakitug (ATI-045) in patients with moderate-to-severe atopic dermatitis (AD). “We are excited to initiate this Phase 2 trial following the strong single arm Phase 2a results in patients with moderate-to-severe AD,” said Dr. Jesse Hall, Chief Medical Officer of Aclaris. “In that trial, bosakitug demonstrated improvements in efficacy measures at week 26 including EASI-75 scores in 94% of participants and clear or nearly clear skin in 88% of participants as measured by IGA scores of 0/1. With demonstrated superior potency and residence time, and unique TSLP binding characteristics, we believe that bosakitug is competitively positioned as a potential best-in-class anti-TSLP therapeutic monoclonal antibody. We expect to provide top line results from this trial in the second half of 2026.” This randomized, double-blind, placebo-controlled global Phase 2 trial is designed to evaluate the efficacy and safety of bosakitug in approximately 90 patients with moderate-to-severe atopic dermatitis. The primary endpoint is percent change from baseline in Eczema Area and Severity Index (EASI) at week 24. Secondary endpoints at week 24 include EASI response (EASI-50, EASI-75, EASI-90), validated Investigator Global Assessment (IGA) response, body surface area (BSA) response, and Peak Pruritus Numerical Rating Scale (PP-NRS) score, relative to baseline. Safety and tolerability will also be assessed. About Bosakitug (ATI-045) Bosakitug is an investigational humanized anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody that specifically binds to human TSLP, blocking its interaction with the receptor complex and disrupting signal transduction. This mechanism prevents immune cells targeted by TSLP from releasing proinflammatory cytokines. Bosakitug has potential best-in-class properties, includin...