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Spyre Therapeutics Announces First Participant Dosed in Phase 1 Trial of SPY003, its Novel Half-life Extended IL-23 Antibody

On March 27, 2025, Spyre Therapeutics, Inc., a clinical-stage biotechnology company based in WALTHAM, Mass., announced the initiation of dosing in a Phase 1 clinical trial of SPY003, its investigational half-life extended anti-IL-23 monoclonal antibody, in healthy volunteers.
Spyre is developing treatments for Inflammatory Bowel Disease and other immune-mediated diseases, with approximately 2.4 million individuals in the United States currently affected by IBD.
The Phase 1 study is expected to enroll approximately 56 healthy adult participants, and preclinical data indicates SPY003 is highly potent and exhibited a significantly longer half-life in non-human primates, demonstrating equivalent potency to risankizumab in inhibiting pSTAT signaling.
According to Deanna Nguyen, M.D., SVP of Clinical Development at Spyre, "We look forward to presenting the interim Phase 1 data in the second half of this year before adding SPY003 as the final monotherapy component of our planned Phase 2 platform trial in ulcerative colitis which will evaluate three investigational monotherapies and three investigational combination therapies."
Spyre anticipates progressing into Phase 2 development pending Phase 1 trial data, with expectations to present interim pharmacokinetic and safety data in the second half of 2025, and believes SPY003 has the potential for quarterly or biannual dosing, offering improved efficacy and convenience compared to first-generation anti-IL-23 monoclonal antibodies.

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