Spyre Therapeutics Announces Interim Phase 1 Data From First-In-Human Trial Of SPY003Across 59 Participants; SPY003 Well Tolerated Throughout All Doses

Spyre Therapeutics, Inc. (NASDAQ: SYRE), a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease ("IBD") and rheumatic diseases, today announced positive interim Phase 1 results from its first-in-human trial of SPY003, an investigational, extended half-life antibody targeting the p19 subunit of IL-23.

The SPY003 Phase 1 trial was a first-in-human, randomized, double-blind, placebo-controlled study designed to evaluate safety and pharmacokinetic (PK) in healthy volunteers. The trial enrolled 59 healthy adult participants into five single-ascending dose (SAD) cohorts, a multiple dose cohort (MD), and a Chinese ethnobridging (Ch Eb) single dose cohort. Doses of SPY003 evaluated included 200 mg IV, 600 mg SC (two formulations), 600 mg IV, and 1200 mg IV (as single and multiple doses).