Theravance Bio Stock Tanks Over 20% After Ulcerative Colitis Drug Trial Fails To Meet Primary Goals

Shares of Theravance Biopharma, Inc. (TBPH) tanked over 20% in extended trading session on Monday after the biopharmaceutical company said that a dose-finding study of its drug izencitinib failed to meet primary endpoint.

Izencitinib is an orally administered, gut-selective pan-Janus kinase inhibitor in development for the treatment of ulcerative colitis. The phase 2b dose-finding induction study did not meet its primary endpoint of change in the total Mayo score or the key secondary endpoint of clinical remission at week 8, relative to placebo.

There was a small dose-dependent increase in clinical response measured by the adapted Mayo score, which was driven by a reduction in rectal bleeding.

"We had high expectations for the Phase 2b study after eight weeks of treatment with izencitinib in ulcerative colitis given the totality and consistency of the broad range of clinical, histologic, and biomarker data we saw in the Phase 1b study with only four weeks of treatment, albeit in a small number of patients. We plan to analyze the data to better understand the findings and the potential for optimization of a gut-selective medicine as a treatment for patients with inflammatory bowel diseases," said Rick E Winningham, Chief Executive Officer, Theravance Biopharma.

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