Clinical-stage biotechnology company Spyre Therapeutics Inc (NASDAQ:SYRE) announced on Thursday that it has started dosing of a healthy volunteer in a Phase 1 clinical trial of its investigational half-life extended anti-IL-23 monoclonal antibody, SPY003.

SPY003 is an investigational, novel, extended half-life monoclonal antibody targeting IL-23 being developed for the potential treatment of Inflammatory Bowel Disease (IBD).

The double-blind, placebo-controlled single-ascending dose study is being conducted in approximately 56 healthy adult participants, primarily studying safety, with pharmacokinetics (PK) as a secondary endpoint. Interim safety, PK and ADA data are expected to be released in the second half of 2025.

Deanna Nguyen, M.D., SVP of Clinical Development at Spyre, said: "Recent third-party clinical data demonstrate that combination therapies that include an IL-23 antibody can produce superior results for IBD patients. We believe SPY003 has the potential to be a best-in-class IL-23 antibody and a compelling combination partner with our α4β7 and TL1A antibodies that can be delivered on a quarterly or bi-annual treatment schedule. 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."