Theravance Biopharma Inc. (NASDAQ: TBPH) has announced top-line results or the Phase 2b dose-finding izencitinib induction study. Izencitinib is an orally delivered gut-selective Pan-Janus Kinase inhibitor the company is developing for ulcerative colitis treatment.
The study didn’t meet primary and secondary endpoints
The primary endpoint of Mayo scores total change and the crucial secondary clinical remission endpoint at week eight were not met in comparison to placebo. The amended Mayo score showed a small dose-dependent clinical response increase driven by rectal bleeding reduction.
Notably, tolerability of Izencitinib was encouraging at all doses when orally given once [per day for eight weeks. Equally adverse events were comparable in individuals receiving izencitinib and those in the placebo group. In individuals taking izencitinib, there were no cases of opportunistic infection, perforation, significant thromboembolic or cardiovascular events, non-melanoma skin cancer, or complex zoster. Additionally, in comparison to the placebo, there were no significant changes in lab parameters such as lipids and creatine phosphokinase in patients using izencitinib. Izencitinib plasma exposure was modest, which was expected for a gut-selective medication.
Theravance BioPharma to report Phase 2 study in Crohn’s in Q4 2021
CEO Rick E Winningham said, “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.”
Winningham added, “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.”