Clinical TrialJun 15, 2026, 08:07 AM
Spyre SPY002 Phase 2 UC trial meets primary endpoint with 10.7-pt RHI reduction
AI Summary
Spyre Therapeutics announced positive initial 12-week induction topline data from Part A of its Phase 2 SKYLINE trial for SPY002 in moderately-to-severely active ulcerative colitis. SPY002 met its primary endpoint, demonstrating a statistically significant 10.7-point reduction in the Robarts Histopathology Index (RHI) score. The drug also showed robust rates of clinical remission (33%) and endoscopic improvement (42%), and was well tolerated with a safety profile consistent with its class.
Key Highlights
- SPY002 achieved primary endpoint with a statistically significant 10.7-point reduction in RHI score (p<0.0001).
- Clinical remission rate was 33% at Week 12.
- Endoscopic improvement rate was 42% at Week 12.
- Modified Mayo Score showed a change of -3.7 points.
- SPY002 was well tolerated, with 41.7% of subjects experiencing any treatment-emergent adverse events.
- Two serious adverse events (4.2%) were reported, both deemed not drug-related.
- No drug-related serious adverse events or deaths occurred during the induction period.
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