05:49 PM EDT, 03/27/2025 (MT Newswires) -- Spyre Therapeutics ( SYRE ) said Thursday it has begun dosing in a phase 1 trial for SPY003, its investigational extended half-life anti-IL-23 monoclonal antibody, in healthy volunteers.
The phase 1 trial is a double-blind, placebo-controlled, single-ascending dose study enrolling about 56 healthy adult participants. The study's primary endpoint is safety, with pharmacokinetics as a secondary endpoint, the biotechnology company said.
Preclinical data suggest SPY003 is highly potent and may allow for quarterly or biannual dosing, potentially improving efficacy and convenience over first-generation IL-23 antibodies.
Spyre plans to incorporate SPY003 into its planned Phase 2 ulcerative colitis study evaluating multiple monotherapy and combination treatments, pending interim results.
Interim safety, pharmacokinetics, and anti-drug antibody data are expected in the second half of 2025, the company added.