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Astria Therapeutics announces FDA clearance for STAR-0310 IND application

Astria Therapeutics (ATXS) announced the FDA clearance of its investigational new drug, or IND, application for STAR-0310, a monoclonal antibody OX40 antagonist, the company is developing as a potential treatment for atopic dermatitis (AD) and potentially other indications. A Phase 1a trial of STAR-0310 in healthy subjects is expected to initiate in the first quarter of 2025, with early proof-of-concept results expected in the third quarter of 2025. Further, the company anticipates proof-of-concept results in atopic dermatitis patients in the second quarter of 2026.

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