Theravance Biopharma, Inc. (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.

The 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.

At 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.

The Company plans to present study results at a scientific forum.

"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. "We are grateful to all those who participated in this clinical trial and to those who are still participating in the Crohn's Phase 2 study – which we expect to report top-line results in late fourth quarter 2021 or early first quarter 2022."

Regarding current plans, the Company will work to understand the complete results and implications for izencitinib. Forthcoming ulcerative colitis data will include results from the 16-week extended induction portion of the study and the 44-week maintenance study. The Company reiterates timing of the top-line results of the Crohn's Phase 2 study in late fourth quarter 2021 or early first quarter 2022. Based on the ulcerative colitis results, the Company will seek to minimize future expenses associated with the izencitinib program.

Conference Call and Live Webcast Today at 5 pm ET

Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 5 pm ET / 2 pm PT / 10 pm IST. To participate, please dial (855) 296-9648 from the U.S. or (920) 663-6266 for international callers, using the confirmation code 3198387. Those interested in listening to the conference call live via the internet may do so by visiting Theravance.com, under the Investors section, Events and Presentations.

A replay will be available on Theravance.com under the Investors section for 30 days. An audio replay will be also available through 8:00 p.m. ET on August 30, 2021, by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers, and then entering confirmation code 3198387.