Aclaris Therapeutics Secures U.S. Food and Drug Administration IND Clearance for ATI-052, Enabling Advancement of its Novel Bispecific Anti-TSLP/IL-4R Investigational Antibody

Core Insights - Aclaris Therapeutics has received FDA clearance for its Investigational New Drug (IND) application for ATI-052, a bispecific anti-TSLP/IL-4R monoclonal antibody, with a Phase 1a/1b clinical trial expected to begin in Q2 2025 [1][2][5] Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for immuno-inflammatory diseases, with a robust R&D pipeline [6] - The company has exclusive worldwide rights to ATI-052, excluding Greater China, and aims to address unmet medical needs in this therapeutic area [5][6] Product Details - ATI-052 is designed to target thymic stromal lymphopoietin (TSLP) and interleukin-4 receptor (IL-4R), inhibiting a central proinflammatory pathway, which may enhance efficacy compared to traditional monoclonal antibodies [5][3] - The bispecific antibody technology allows for dual binding to two targets, potentially improving treatment outcomes for various immune-modulated diseases [3] Clinical Trial Information - The upcoming Phase 1a/1b trial will be randomized, blinded, and placebo-controlled, evaluating both single and multiple ascending doses of ATI-052 [2] - The trial will also include a proof-of-concept portion for an undisclosed indication [2]