Core Insights - Spyre Therapeutics has initiated a Phase 1 clinical trial for SPY003, an investigational anti-IL-23 monoclonal antibody, which is expected to offer improved dosing convenience and efficacy compared to first-generation therapies [1][2][3] - The company anticipates interim pharmacokinetic and safety data from the trial in the second half of 2025, which will inform the progression to a Phase 2 study in ulcerative colitis [1][2][3] Company Overview - Spyre Therapeutics is focused on developing next-generation therapies for Inflammatory Bowel Disease (IBD) and other immune-mediated diseases through advanced antibody engineering and therapeutic combinations [4] - The company’s pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23, with SPY003 being a key candidate [4] Clinical Trial Details - The Phase 1 trial of SPY003 is a double-blind, placebo-controlled study involving approximately 56 healthy adult participants, primarily assessing safety as the primary endpoint and pharmacokinetics as a secondary endpoint [2][3] - SPY003 has shown equivalent potency to risankizumab in preclinical studies, with a significantly longer half-life, potentially allowing for dosing as infrequently as once every six months [3]
Spyre Therapeutics Announces First Participant Dosed in Phase 1 Trial of SPY003, its Novel Half-life Extended IL-23 Antibody