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Spyre Therapeutics Announces Poster Presentations at Digestive Disease Week (DDW) 2025 Including Up to Eight months of Follow-up from an Ongoing Phase 1 Trial of SPY001
SPY001 is a novel, half-life extended α4β7 antibody in development for the treatment of Inflammatory Bowel Disease (IBD) SPY001 pharmacokinetic (PK) data up
About this update from Spyre Therapeutics, Inc.
[{"type":"text","content":"SPY001 is a novel, half-life extended α4β7 antibody in development for the treatment of Inflammatory Bowel Disease (IBD)\nSPY001 pharmacokinetic (PK) data up to eight months continues to support a potential best-in-class profile, including a half-life more than three times that of vedolizumab\nSPY001 pharmacodynamic (PD) data up to eight months showed that a single dose of SPY001 resulted in rapid and sustained saturation of α4β7 receptors at expected Phase 2 trough concentrations\nSpyre remains on track to initiate its planned platform Phase 2 trial in mid-2025 that includes SPY001, followed by SPY002 (TL1A), SPY003 (IL-23), and combinations thereof, with initial monotherapy data expected in 2026\nWALTHAM, Mass., May 5, 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 two poster presentations at Digestive Disease Week (DDW) 2025, being held May 3-6, 2025, in San Diego, California.\nSpyre presented results out to eight months of follow up from its SPY001 Phase 1 program. Updated results from our ongoing Phase 1 trial of SPY001, our novel half-life extended α4β7 antibody for the treatment of IBD, continues to show that SPY001 is well tolerated, has a half-life of more than three-fold compared to vedolizumab based on population PK modeling, and sustains target engagement at expected Phase 2 trough concentrations. This longer follow-up data strengthens the potential for SPY001 to demonstrate improved induction responses with greater exposures as well as durable responses with quarterly or biannual maintenance dosing.Spyre presented expanded preclinical data on combined inhibition of α4β7 integrin and TL1A cytokine in murine colitis models. Data presented demonstrate that combined inhibition of α4β7 integrin and TL1A cytokine is superior to either monotherapy in mouse models of colitis.\"Extended follow-up data continue to show that SPY001 is well tolerated and has a PK and PD profile that supports potential best-in-class quarterly or biannual dosing for patients with IBD,\" said Deanna Nguyen, MD, SVP of Clinical Development at Spyre. \"We l...