Theravance Stock Plunges As JAK Inhibitor Flops Ulcerative Colitis Study
- Theravance Biopharma Inc's (NASDAQ: TBPH) Izencitinib, a "gut-selective" JAK inhibitor developed for ulcerative colitis and Crohn's disease, failed a key Phase 2 trial.
- Johnson & Johnson's (NYSE: JNJ) pharmaceutical unit Janssen dished out $100 million upfront in a partnership with Theravance to develop Izencitinib back in 2018.
- Another $900 million in milestones are on the line for the therapy, which Theravance is also testing in a Phase 2 trial for Crohn's disease.
- Janssen can opt-out of the collaboration following the phase 2 studies.
- The Crohn's data is due in Q4 of 2021 or Q1 of 2022.
- In the eight-week induction portion of the Phase 2 trial, Izencitinib failed to show benefit over placebo on the Mayo score improvement primary endpoint or clinical remission, a key secondary endpoint.
- Theravance noted "a small dose-dependent increase in clinical response" measured by Mayo, but not enough to drive significant benefit.
- Regarding current plans, Theravance 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.
- Related: Theravance's another JAK Inhibitor Nezulcitinib Failed In Phase 2 COVID-19 Study.
- Price Action: TBPH shares are trading down 27.38% at $10.29 in premarket on the last check Tuesday.
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