Theravance Stock Plunges As JAK Inhibitor Flops Ulcerative Colitis Study

  • Theravance Biopharma Inc's TBPH Izencitinib, a "gut-selective" JAK inhibitor developed for ulcerative colitis and Crohn's disease, failed a key Phase 2 trial.
  • Johnson & Johnson's 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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