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Spyre Therapeutics Announces First Participant Dosed in Phase 1 Trial of SPY003, its Novel Half-life Extended IL-23 Antibody
Preclinical data demonstrates that SPY003 is highly potent and has potential forquarterly or biannual dosing, suggesting opportunity for improved efficacy
About this update from Spyre Therapeutics, Inc.
[{"type":"text","content":"Preclinical data demonstrates that SPY003 is highly potent and has potential forquarterly or biannual dosing, suggesting opportunity for improved efficacy andconvenience over first-generation anti-IL-23 monoclonal antibodies \nInterim pharmacokinetic and safety data from healthy volunteers for SPY003 anticipatedin the second half of 2025\nSubject to interim results, Spyre expects to incorporate SPY003 into its planned Phase2 study in ulcerative colitis exploring six investigational monotherapies andcombinations\nWALTHAM, Mass., March 27, 2025 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ: SYRE) (the \"Company\" or \"Spyre\"), a clinical-stage biotechnology company advancing best-in-class antibody engineering, dose optimization, and rational therapeutic combinations for the treatment of Inflammatory Bowel Disease (\"IBD\") and other immune-mediated diseases, today announced that it has initiated dosing in a healthy volunteer, Phase 1 clinical trial of its investigational half-life extended anti-IL-23 monoclonal antibody, SPY003. This milestone marks our fourth on-time clinical trial initiation in nine months.\n\"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.\" said Deanna Nguyen, M.D., SVP of Clinical Development at Spyre. \"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.\"\nThe SPY003 Phase 1 Trial (NCT06873724) is a double-blind, placebo-controlled single-ascending dose study in healthy volunteers. The study is expected to enroll approximately 56 healthy adult participants. The primary endpoint is safety, with pharmacokinetics (PK) serving as a secondary endpoint. Interim safety, PK, and ADA data from this trial are expected in the second half of 2025.\nAbout SPY003\nSPY003 is an investigational, novel, extended half-life monoclonal antibody targeting IL-23, ...