Astria Therapeutics, Inc. announced on September 17, 2025, positive initial results from the Phase 1a trial of STAR-0310 in healthy subjects. STAR-0310, a YTE half-life extended monoclonal antibody antagonist of OX40, demonstrated a best-in-class half-life of up to 68 days, supporting potential every-six-month administration.
The trial also showed durable cytokine inhibition lasting at least 20 weeks after a single 300 mg subcutaneous injection, indicating robust target engagement and modulation of a broad spectrum of immune pathways. STAR-0310 was well-tolerated across all dose levels, with no serious treatment-emergent adverse events (TEAEs) or discontinuations, and notably, no ADCC-related TEAEs such as fever or chills were observed.
These results support STAR-0310's potential as a best-in-class OX40 antagonist, offering a wider therapeutic window and the potential for greater efficacy without dose-limiting side effects seen in first-generation OX40 antibodies. The favorable safety profile and infrequent dosing regimen could significantly reduce treatment burden for people living with moderate-to-severe atopic dermatitis, particularly those who do not respond to existing biologics.
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