Spyre Therapeutics' SPY003 Meets Phase 2 Primary Endpoint in Ulcerative Colitis

MT Newswires Live09-08 21:35

Spyre Therapeutics' (SYRE) SPY003 met the primary endpoint in the phase 2 Skyline trial, reducing the Robarts Histopathology Index score by 10 points at week 12 in patients with moderately to severely active ulcerative colitis, the company said Tuesday.

The anti-IL-23 therapy achieved a 20% clinical-remission rate, measured by modified Mayo Score, and a 30% endoscopic-improvement rate, while remaining well tolerated with a safety profile consistent with the IL-23 class, the company said.

The results complete clinical proof-of-concept for all three components of Spyre's IBD strategy, with part B of the SKYLINE trial evaluating pairwise combinations now enrolling.

Spyre expects topline SKYLINE part B induction data in 2027, with phase 2 SKYWAY results for SPY072 in psoriatic arthritis and axial spondyloarthritis expected in the fourth quarter of 2026, it added.

Spyre Therapeutics shares were down 1.1% in premarket activity.

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