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Theravance Stock Drops; Ulcerative-Colitis Drug Doesn't Meet Endpoint

Theravance's izencitinib for ulcerative colitis failed to meet a Phase 2 study's primary and secondary endpoints.
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Shares of Theravance Biopharma  (TBPH) - Get Theravance Biopharma Inc Report dropped  on Tuesday after the company reported that its oral ulcerative colitis treatment, izencitinib, failed to meet key endpoints in a Phase 2 trial. 

The Cayman Islands company said the drug did not meet its primary endpoint of a change in the total Mayo score. A drug's Mayo score is a composite of sub-scores including stool frequency, rectal bleeding and other categories. 

"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," Chief Executive Rick E Winningham said in a statement.

Theravance Biopharma shares at last check dropped 31% to $9.84. 

The drug also missed its secondary endpoint of clinical remission at week 8 relative to a placebo. 

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"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," Winningham said. 

The company said izencitinib was well-tolerated when administered by mouth once daily for eight weeks. 

It says it will work to understand the complete results with forthcoming ulcerative colitis data from the 16-week extended induction portion study and the 44-week maintenance study. 

The company reiterated the timing of top-line results of the Crohn's Phase 2 study for late in the fourth quarter or early in the first quarter.