Spyre Therapeutics says SPY003 met primary endpoint in ulcerative colitis trial
Spyre Therapeutics reported 12-week Part A induction results from the Phase 2 SKYLINE trial of SPY003, an anti-IL-23 antibody in development for moderately-to-severely active ulcerative colitis. SPY003 met its primary endpoint with a 10.0-point reduction in Robarts Histopathology Index score from baseline (p<0.0001), and the company reported no drug-related serious adverse events for the drug. For shareholders, the results complete proof-of-concept for all three monotherapy components of the company's IBD combinations, but the data come from a 44-subject open-label study and do not include financial results.
Key points
- Primary endpoint: 10.0-point RHI reduction at Week 12 (p<0.0001) in 44 subjects receiving SPY003, with clinical remission at 20% and endoscopic improvement at 30%
- Safety: 19 subjects (43%) had treatment-emergent adverse events; 3 serious adverse events were reported, all deemed not drug-related
- Next readouts: SKYWAY sub-studies (SPY072) expected 4Q 2026; SKYLINE Part B topline induction data expected in 2027
The filing
Written by AI on Nov 9, 2026, 8:53 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 08, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.