Pfizer's Ulcerative Colitis Candidate Shows Remission In Over 30% Of Patients In Pivotal Studies

  • Pfizer Inc PFE has announced detailed results from two pivotal studies from ELEVATE UC Phase 3 program evaluating etrasimod for active ulcerative colitis (UC). 
  • The drug, etrasimod, was Pfizer's key asset in its $6.7 billion deal for Arena Pharmaceuticals last year. 
  • UC is an inflammatory bowel disease that affects around 3.8 million people in North America and Europe.
  • In its 52-week, 433-patient study, 32.1% of etrasimod patients were in clinical remission after one year, compared with 6.7% for those who got a placebo.
  • Twelve weeks into that trial, clinical remission was 27% among etrasimod recipients versus 7.4% in the placebo arm.
  • In a separate 12-week study, Pfizer said clinical remission was achieved among 24.8% of patients receiving etrasimod compared to 15.2% of patients receiving a placebo.
  • Treatment-emergent adverse events (AEs), including serious AEs, were similar between treatment groups. 
  • The most common treatment-emergent AEs were headaches, UC worsening, COVID-19 infection, dizziness, pyrexia, arthralgia, abdominal pain, and nausea. 
  • Price Action: PFE shares are down 0.62% at $52.55 during the premarket session on the last check Tuesday.

Posted In: BiotechLarge CapNewsHealth CareGeneralBriefsPhase 3 Trial