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Spyre Therapeutics Announces First Participants Dosed in Phase 1 Trial of SPY001, its Novel Half-life Extended anti-α4β7 Antibody, for the Treatment of Inflammatory Bowel Disease
Preclinical data for SPY001 demonstrate the potential for improved dosing over standard of care, including the potential for dosing every eight or twelve
About this update from Spyre Therapeutics, Inc.
[{"type":"text","content":"Preclinical data for SPY001 demonstrate the potential for improved dosing over standard of care, including the potential for dosing every eight or twelve weeks compared to dosing every two weeks for subcutaneous vedolizumab\nInterim subcutaneous pharmacokinetic and safety data from healthy volunteers anticipated by year-end 2024\nSPY002, an extended half-life anti-TL1A antibody designed for enhanced potency to both TL1A monomers and trimers, remains on track to begin first-in-human studies in the second half of 2024\nAll three next-generation antibodies targeting α4β7, TL1A, and IL-23 are on track to be in the clinic within 12 months, each serving as backbones for potential best-in-class combinations\nWALTHAM, Mass., June 18, 2024 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ: SYRE) (the \"Company\" or \"Spyre\"), a clinical-stage biotechnology company utilizing best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches to target improved efficacy and convenience in the treatment of Inflammatory Bowel Disease (\"IBD\"), today announced that it has initiated dosing of healthy volunteers in its first clinical trial of SPY001, an investigational novel half-life extended anti-α4β7 monoclonal antibody.\n\"The Spyre team has executed efficiently to achieve this milestone within a year of our public launch. SPY001 is the first of our programs across three of the most impactful mechanisms in IBD, namely α4β7, TL1A, and IL-23, all of which are expected to enter the clinic within the next twelve months,\" said Cameron Turtle, D.Phil., Chief Executive Officer of Spyre. \"We look forward to highlighting interim data for SPY001 by the end of this year, which we expect will confirm that SPY001 is well tolerated with a half-life that enables a convenient Q8-12W subcutaneous dosing schedule, with interim data for our T1LA program to follow.\"\nThe SPY001 Phase 1 trial is a double blind, placebo-controlled study in healthy volunteers and consists of a single-ascending dose (SAD) component and a multi-ascending dose (MAD) component. The study is expected to enroll approximately 48 healthy adult participants into four SAD cohorts and two MAD cohorts. The primary endpoint is safety, with pharmacokinetics (PK) serving as a secondary endpoint. We expect interim safety and PK data from this trial by yea...