Spyre SPY003 Phase 2 UC: 10-point RHI reduction (p<0.0001), 20% remission, 30% endoscopic improvement

Spyre Therapeutics, Inc.

SPY003 met primary endpoint: 10.0-point reduction in RHI from baseline at Week 12 (p<0.0001) in 44 patients with moderate-to-severe UC.
Secondary endpoints: 20% clinical remission by modified Mayo Score, 30% endoscopic improvement, -3.5 change in mMS.
Safety: 19 TEAEs (43%), 3 SAEs deemed not drug-related, no drug-related SAEs or deaths; consistent with IL-23 class.
Completes proof-of-concept for all three IBD components (SPY001, SPY002, SPY003); Part B combination trial enrolling, topline data expected 2027.
Additional readouts: SKYWAY (SPY072) 4Q 2026; SKYLIGHT (HS) late 2027/early 2028.

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