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FDA Clears IND Application for Novel Monoclonal Antibody OX40 Antagonist for Atopic Dermatitis

The FDA has cleared the Investigational New Drug application for STAR-0310, a novel monoclonal antibody OX40 antagonist developed by Astria Therapeutics for treating atopic dermatitis. A Phase 1a trial in healthy volunteers is expected to start in the first quarter of 2025, with early proof-of-concept data anticipated by the third quarter of 2025.

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.
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Reference News

[1]
Atopic Dermatitis pipeline: IND Application Cleared by FDA for Novel Monoclonal Antibody ...
patientcareonline.com · Jan 15, 2025

Astria Therapeutics plans a Phase 1 trial for STAR-0310, a monoclonal antibody targeting atopic dermatitis, starting in ...

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