Spyre Therapeutics expects acceleration of SPY003 clinical timeline

Spyre Therapeutics announced updated pipeline progress and timelines, as well as scientific presentations at the United European Gastroenterology Week Congress. First-in-human dosing of SPY003 in healthy volunteers is now expected to start during Q1 2025. SPY003 is a novel mAb targeting IL-23p19. Approved inhibitors of IL-23 are effective and well tolerated treatments of moderate-to-severe IBD. The company expects to share interim data from the accelerated first-in-human trial in the second half of 2025. With an extended half-life in NHPs, SPY003 demonstrates therapeutic potential for effective and well-tolerated treatment of Crohn’s disease and Ulcerative Colitis with less frequent dosing than approved therapies. Spyre presented preclinical data combining anti-IL-23 with either anti-alpha4beta7 or anti-TL1A for the first time at UEGW. The models showed that IL-23 and TL1A have a synergistic effect on promoting IL-17 secretion from human and mouse immune cells, and that the combination of anti-IL-23 and anti-TL1A suppresses IL-17 secretion more effectively than either agent alone.