Clinical TrialApr 13, 2026, 07:01 AM
Spyre's SPY001 Hits Primary Endpoint in Phase 2 UC Trial
AI Summary
Spyre Therapeutics announced positive 12-week induction data from Part A of its Phase 2 SKYLINE trial for SPY001 in moderate-to-severely active ulcerative colitis. SPY001 met its primary endpoint with a statistically significant 9.2-point reduction in RHI score (p<0.0001) and demonstrated strong secondary endpoints, including 40% clinical remission and 51% endoscopic improvement. The drug was well tolerated, and the company is now enrolling Part B, including combination cohorts, with further data for other candidates expected in mid-2026 and Q3 2026.
Key Highlights
- SPY001 achieved a 9.2-point reduction in Robart's Histopathology Index (RHI) score (p<0.0001).
- 40% of patients achieved clinical remission by modified Mayo Score.
- 51% of patients showed endoscopic improvement.
- SPY001 was well tolerated with a safety profile consistent with the "47 class.
- Recruitment for SKYLINE Part A closed; Part B enrollment is now open.