Preclinical data demonstrates that SPY003 is highly potent and has potential for
quarterly or biannual dosing, suggesting opportunity for improved efficacy and
convenience over first-generation anti-IL-23 monoclonal antibodies
Interim pharmacokinetic and safety data from healthy volunteers for SPY003 anticipated
in the second half of 2025
Subject to interim results, Spyre expects to incorporate SPY003 into its planned Phase
2 study in ulcerative colitis exploring six investigational monotherapies and
combinations
WALTHAM, MA, USA I March 27, 2025 I 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.
“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.”
The 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.
About SPY003
SPY003 is an investigational, novel, extended half-life monoclonal antibody targeting IL-23, being developed for the potential treatment of IBD. IBD is a chronic condition characterized by inflammation in the gastrointestinal tract and encompasses two main disorders: ulcerative colitis and Crohn’s disease. In the United States, it is estimated that approximately 2.4 million individuals currently have IBD. In head-to-head preclinical studies, SPY003 demonstrated equivalent potency to risankizumab in inhibiting pSTAT signaling and IL-17 production and exhibited significantly longer half-life in non-human primates with the potential to deliver dosing in humans as infrequently as once every six months. A Phase 1 trial of SPY003 in healthy volunteers is ongoing, and the Company expects interim safety and pharmacokinetic data in the second half of 2025. Pending data from the Phase 1 trial, the company anticipates progressing into Phase 2 development.
About Spyre Therapeutics
Spyre Therapeutics is a biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre’s pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23. For more information, visit Spyre’s website at www.spyre.com.
SOURCE: Spyre Therapeutics
Post Views: 1,148
Preclinical data demonstrates that SPY003 is highly potent and has potential for
quarterly or biannual dosing, suggesting opportunity for improved efficacy and
convenience over first-generation anti-IL-23 monoclonal antibodies
Interim pharmacokinetic and safety data from healthy volunteers for SPY003 anticipated
in the second half of 2025
Subject to interim results, Spyre expects to incorporate SPY003 into its planned Phase
2 study in ulcerative colitis exploring six investigational monotherapies and
combinations
WALTHAM, MA, USA I March 27, 2025 I 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.
“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.”
The 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.
About SPY003
SPY003 is an investigational, novel, extended half-life monoclonal antibody targeting IL-23, being developed for the potential treatment of IBD. IBD is a chronic condition characterized by inflammation in the gastrointestinal tract and encompasses two main disorders: ulcerative colitis and Crohn’s disease. In the United States, it is estimated that approximately 2.4 million individuals currently have IBD. In head-to-head preclinical studies, SPY003 demonstrated equivalent potency to risankizumab in inhibiting pSTAT signaling and IL-17 production and exhibited significantly longer half-life in non-human primates with the potential to deliver dosing in humans as infrequently as once every six months. A Phase 1 trial of SPY003 in healthy volunteers is ongoing, and the Company expects interim safety and pharmacokinetic data in the second half of 2025. Pending data from the Phase 1 trial, the company anticipates progressing into Phase 2 development.
About Spyre Therapeutics
Spyre Therapeutics is a biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre’s pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23. For more information, visit Spyre’s website at www.spyre.com.
SOURCE: Spyre Therapeutics
Post Views: 1,148
