Spyre Therapeutics, Inc.
For the period ended Sep 8, 2026. Filed Sep 8, 2026.
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Sep 8, 2026 · Filed Sep 8, 2026
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Efficacy: POC Established Across All Three Combination Components
Initial 12-week findings from SKYLINE Part A demonstrated that SPY003 met all key objectives. The study population consisted of 41% advanced therapy-exposed participants with a mean disease duration of 7.1 years, a mean baseline Robarts Histopathology Index (“RHI”) score of 17.2 ± 8.3 (SD), a mean modified Mayo Score (“mMS”) of 6.9 ± 1.2 (SD), and 59% of whom had a baseline endoscopy score of 3. SPY003 achieved the primary endpoint, demonstrating a statistically significant 10.0-point reduction in RHI score (p<0.0001), robust rates of clinical remission and endoscopic improvement, and a meaningful change in mMS. The 10.0-point reduction in RHI observed in participants receiving SPY003 is in line with the 9.2- and 10.7-point reductions observed in participants receiving SPY001 and SPY002, respectively, and all are among the largest improvements observed in UC trials to date.
| Endpoint (Week 12) | SPY003 |
|---|---|
| Change in RHI from baselinePrimary endpoint | -10.0(p<0.0001) |
| Clinical remission rate | 20% |
| Endoscopic improvement rate | 30% |
| Change in modified Mayo Score | -3.5 |
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