Spyre Therapeutics, Inc. announced the initiation of dosing in a healthy volunteer, Phase 1 clinical trial for its investigational half-life extended anti-IL-23 monoclonal antibody, SPY003. This milestone represents the company's fourth on-time clinical trial initiation within nine months.
Preclinical data for SPY003 demonstrated high potency and the potential for quarterly or biannual dosing, suggesting improved efficacy and convenience compared to first-generation anti-IL-23 monoclonal antibodies. Interim pharmacokinetic and safety data from this trial are anticipated in the second half of 2025.
Subject to positive interim results, Spyre expects to incorporate SPY003 into its planned Phase 2 study in ulcerative colitis. The company believes SPY003 has the potential to be a best-in-class IL-23 antibody and a compelling combination partner with its α4β7 and TL1A antibodies.
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