Spyre Therapeutics, Inc. 8K

Spyre Therapeutics reported that its anti-IL-23 candidate SPY003 met the primary and key secondary endpoints in Part A of the Phase 2 SKYLINE ulcerative colitis trial, completing proof-of-concept for all three components of its IBD combination program and enabling progression to Part B combination studies.

On September 8, 2026, Spyre Therapeutics, Inc. announced positive 12-week Part A induction data from its Phase 2 SKYLINE trial for SPY003, an extended half-life anti-IL-23 monoclonal antibody for moderately-to-severely active ulcerative colitis, reporting that SPY003 met its primary endpoint with a statistically significant 10-point reduction in Robart’s Histopathology Index, achieved secondary efficacy endpoints including 20% clinical remission and 30% endoscopic improvement, and showed a safety profile consistent with the IL-23 class; together with prior SPY001 and SPY002 data, this establishes clinical proof-of-concept for all three investigational IBD monotherapies and supports continued enrollment of SKYLINE Part B combination cohorts, with topline induction data expected in 2027.

Filing Facts

CIK

1636282

Ticker

SYRE

Form

8K

Source Type

fda

Accession

0001636282-26-000113

Alert Tier

6