Spyre Therapeutics has initiated dosing of healthy volunteers in its first clinical trial of SPY001, an investigational novel half-life extended anti-alpha4beta7 monoclonal antibody, in Inflammatory Bowel Disease or IBD. The SPY001 Phase 1 trial is a study in healthy volunteers and consists of a single-ascending dose component and a multi-ascending dose component. The primary endpoint is safety, with pharmacokinetics serving as a secondary endpoint. Spyre expects interim safety and PK data from this trial by year-end 2024. Pending data from the Phase 1 trial, the company anticipates progressing into Phase 2 development with SPY001 in 2025.
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