Spyre Therapeutics Sees Positive Results From Ulcerative Colitis Trial

Dow Jones
Apr 13
 

By Robb M. Stewart

 

Spyre Therapeutics hit the key target in a trial of its candidate treatment for moderate to severely active ulcerative colitis.

The clinical-stage biotechnology company said Monday it achieved positive 12-week induction data from the first part of its Phase 2 Skyline trial of SPY001.

The study met its primary endpoint with a statistically significant reduction of 9.2 points from baseline at week 12 in a Robart's Histopathology Index score. Secondary endpoints included clinical remission by modified Mayo score of 40% and endoscopic improvement of 51%, Spyre said.

SPY001 was well tolerated, the company said.

Trading in Spyre's shares was halted ahead of the news.

The company said recruitment for part A of Skyline is now closed and that enrollment is open for part B, which it said includes three monotherapy cohorts and three combination cohorts. Proof-of-concept induction data for the remaining cohorts of part A are now expected mid-2026 for SPY002 and in the third quarter for SPY003, Spyre said. Part B induction data for all cohorts remain on track for 2027, it said.

 

Write to Robb M. Stewart at robb.stewart@wsj.com

 

(END) Dow Jones Newswires

April 13, 2026 07:25 ET (11:25 GMT)

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