Spyre SPY001 meets primary endpoint in Phase 2 SKYLINE Part A for UC; 40% clinical remission

Spyre Therapeutics, Inc.

SPY001 achieved primary endpoint with RHI reduction of 9.2 points (p<0.0001) at Week 12.
Secondary endpoints: clinical remission 40%, endoscopic improvement 51%, Modified Mayo Score change -3.7.
Well tolerated: 6 TEAEs (14%), 1 SAE deemed not drug-related; no drug-related AEs or discontinuations.
Part A enrollment closed; Part B enrolling monotherapy (SPY001/002/003) and combination cohorts.
Proof-of-concept data expected mid-2026 for SPY002, Q3 2026 for SPY003; Part B data on track for 2027.

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