Spyre Therapeutics, a clinical-stage biotechnology company, has announced the expected acceleration of its clinical timelines for spy003 (IL-23) and presented new data at the United European Gastroenterology Week Congress. Spy003, a novel half-life extended IL-23p19 monoclonal antibody, is anticipated to begin first-in-human dosing in the first quarter of 2025. The company has also expanded its portfolio of half-life extended antibodies to three validated targets in inflammatory bowel disease (IBD).
The preclinical data on spy003 presented at the congress demonstrated robust activity, including comparable potency and a more than three-fold extension in half-life in non-human primates relative to risankizumab. This extended half-life indicates potential for effective and well-tolerated treatment of Crohn’s disease and ulcerative colitis with less frequent dosing than approved therapies.
In addition to spy003, Spyre's portfolio now includes extended half-life molecules targeting α4b7, TL1A, and IL-23, with potential q8w-q12w maintenance dosing. Preclinical data combining anti-IL-23 with either anti-α4b7 or anti-TL1A for the first time at the congress showed enhanced preclinical efficacy and pharmacodynamics. The combination of anti-IL-23 and anti-TL1A was found to suppress IL-17 secretion more effectively than either agent alone.
Furthermore, additional preclinical data for spy001 (anti-α4b7) and spy002 (anti-TL1A) were presented, including in vitro potency compared to benchmark antibodies, nonclinical safety data, and pharmacokinetics demonstrating extended half-life in non-human primates. Human pharmacokinetic simulations for spy001 and both spy002 candidates support potential q8-12w dosing regimens in IBD.
Cameron Turtle, DPhil, Chief Executive Officer of Spyre, expressed that the company has made significant progress in advancing its potentially best-in-class molecules into first-in-human studies within an expected nine-month window. With these promising molecules against the top three validated targets in IBD, Spyre aims to develop monotherapy and combination products with the potential to meaningfully improve both efficacy and convenience compared to today’s standard of care.
The posters were presented at the UEGW Congress on October 12, 2024, and details are available in Spyre’s updated corporate presentation. The company's pipeline includes investigational extended half-life antibodies targeting α4b7, TL1A, and IL-23, with spy003 expected to begin first-in-human dosing in the first quarter of 2025. Following these announcements, the company's shares moved -1.3%, and are now trading at a price of $30.27. For the full picture, make sure to review Spyre Therapeutics's 8-K report.
