Spyre Therapeutics Announces Positive Phase 2 Topline Data for SPY002 in Ulcerative Colitis

On June 15, 2026, Spyre Therapeutics announced positive initial 12-week induction topline data from Part A of its Phase 2 SKYLINE trial evaluating SPY002, an extended half-life anti-TL1A antibody, in patients with moderately-to-severely active ulcerative colitis (UC). The trial met its primary endpoint, demonstrating a statistically significant 10.7-point reduction in the Robarts Histopathology Index (RHI) score (p<0.0001). Key secondary endpoints showed a clinical remission rate of 33% and an endoscopic improvement rate of 42%. SPY002 was well-tolerated, with a safety profile consistent with the TL1A class. Two serious adverse events were reported, but both were deemed unrelated to the study drug. The company noted that these results are among the highest reported in UC and support the ongoing development of SPY002 both as a monotherapy and in combination treatments. Part B of the SKYLINE trial, which includes combination arms, is currently enrolling. Spyre also remains on track to report Part A data for its anti-IL-23 candidate, SPY003, in Q3 2026.