SPY001, SPY002, SPY003 - (SKYLINE)

June 15, 2026: Spyre Therapeutics, Inc. (NASDAQ: SYRE) reported positive 12-week induction topline data from Part A of the Phase 2 SKYLINE trial of SPY002, an extended half-life anti‑TL1A antibody, in moderately-to-severely active ulcerative colitis.

SPY002 met the primary endpoint, showing a statistically significant mean reduction in Robarts’ Histopathology Index (RHI) of 10.7 points from baseline at Week 12 (p<0.0001). Secondary outcomes included clinical remission (modified Mayo Score) of 33%, endoscopic improvement of 42%, and a mean change in modified Mayo Score of -3.7. The Part A population included 35% advanced therapy-exposed patients.

Safety: SPY002 was reported as well tolerated with a safety profile consistent with the TL1A class. Treatment-emergent AEs occurred in 20/48 (41.7%); Grade ≥3 AEs in 2/48 (4.2%); SAEs in 2/48 (4.2%), both deemed not drug-related (UC exacerbation hospitalization; worsening heart failure in a patient with prior history). No deaths or AEs of special interest were reported.

Upcoming catalysts: enrollment is ongoing for Part B (randomized, placebo-controlled; includes monotherapy dose levels and combination arms). The company plans to report Part A data for SPY003 (anti‑IL‑23) in Q3.