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Spyre Therapeutics announced positive 12-week induction topline data from Part A of the Phase 2 SKYLINE trial for…

SYRESpyre Therapeutics, Inc.

Spyre Therapeutics announced positive 12-week induction topline data from Part A of the Phase 2 SKYLINE trial for SPY003, an anti-IL-23 antibody being investigated for moderately-to-severely active ulcerative colitis. The drug met its primary endpoint with a statistically significant 10.0-point reduction in Robarts Histopathology Index (RHI) score (p<0.0001), alongside clinical remission and endoscopic improvement rates of 20% and 30%, respectively. This result establishes proof-of-concept for all three monotherapy components (SPY001, SPY002, and SPY003) in the company's inflammatory bowel disease portfolio. The filing confirms that Part B of the SKYLINE trial is actively enrolling combination arms, with topline induction data expected in 2027. Spyre Therapeutics operates as a clinical-stage biotechnology company developing next-generation immunology and inflammation therapies.

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