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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Stewart \n\n\n \n\n\nSpyre Therapeutics hit the key target in a trial of its candidate treatment for moderate to severely active ulcerative colitis. \n\n\n  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. \n\n\n  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. \n\n\n  SPY001 was well tolerated, the company said. \n\n\n  Trading in Spyre's shares was halted ahead of the news. \n\n\n  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. \n\n\n \n\n\n  Write to Robb M. Stewart at robb.stewart@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  April 13, 2026 07:25 ET (11:25 GMT)\n\n\n  Copyright (c) 2026 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":true,"editions":null,"column":"","sentiment":"1","news_tag":"dataReport","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":true,"need_login_tip":false,"code":"91000000","status":"200"}}}