Astria Therapeutics, Inc. announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for STAR-0310, a monoclonal antibody OX40 antagonist aimed at treating atopic dermatitis (AD). The company plans to initiate a Phase 1a trial of STAR-0310 in healthy volunteers in the first quarter of 2025.
STAR-0310 is designed with a high-affinity, high-potency structure and low antibody-dependent cellular cytotoxicity (ADCC), which may allow for an expanded therapeutic window and infrequent dosing intervals, potentially as few as every six months. This design could also offer disease-modifying effects.
Chris Morabito, M.D., Chief Medical Officer at Astria Therapeutics, expressed enthusiasm about the OX40 mechanism's potential and the design of STAR-0310, which aims to leverage insights from OX40 receptor and ligand programs. The drug's high affinity and potency, combined with low ADCC, could enable a wider therapeutic window and less frequent dosing due to its long half-life and potential for disease modification.
Early proof-of-concept data from the trial is expected in the third quarter of 2025, with results in patients with AD projected for the second quarter of 2026.
