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Theravance Biopharma, Inc. Announces Top-line Results from Phase 2b Dose-Finding Induction Study of Izencitinib in Patients with Ulcerative Colitis
- Randomized, double-blind, placebo-controlled study did not meet the primary endpoint: change in the total Mayo score at week eight, relative to placebo -
About this update from Theravance Biopharma, Inc.
[{"type":"text","content":"- Randomized, double-blind, placebo-controlled study did not meet the primary endpoint: change in the total Mayo score at week eight, relative to placebo\n - Izencitinib was well-tolerated and safety data were consistent with expectations for this gut-selective pan-JAK inhibitor\n - Investor conference call and webcast today at 5 pm ET (2 pm PT)\n\n\nDUBLIN and SOUTH SAN FRANCISCO, Calif., Aug. 23, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. (\"Theravance Biopharma\" or the \"Company\") (NASDAQ: TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development, and commercialization of organ-selective medicines, today announced top-line results from its Phase 2b dose-finding induction study of izencitinib, an orally administered, gut-selective pan-Janus kinase (JAK) inhibitor in development for the treatment of ulcerative colitis. \n\n \n \n \n \n \n \n\n \nThe 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. \nAt all doses, izencitinib was well-tolerated when administered orally once daily for 8 weeks; adverse event rates were similar among patients receiving izencitinib and placebo. There were no instances of perforation, opportunistic infection, major cardiovascular or thromboembolic event, complicated zoster, or non-melanoma skin cancer in patients receiving izencitinib. There were no notable changes in lab values including creatine phosphokinase and lipids in patients receiving izencitinib relative to placebo. Plasma exposure of izencitinib was low, consistent with expectations for a gut-selective medicine. \nThe Company plans to present study results at a scientific forum.\n\"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 patien...