Bristol Myers Squibb, Janssen Move Closer To Phase 3 For Blood Thinner Candidate

  • Bristol Myers Squibb & Co BMY and Johnson & Johnson's JNJ unit Janssen Pharmaceuticals Inc announced results from the Phase 2 AXIOMATIC-TKR study of Factor XIa inhibitor called milvexian.
  • Milvexian (BMS-986177) significantly lowered patients' rate of venous thromboembolism (VTE) after knee surgery compared to the commonly used anticoagulant enoxaparin, without increasing the risk of infection bleeding.
  • At daily doses of at least 100 mg, those treated with milvexian saw significantly lower VTE rates than enoxaparin. 
  • A group of patients receiving the highest once-daily dose (200mg) of milvexian saw a 7% VTE rate, compared to a 21% rate for the group of patients who took 40 mg of enoxaparin.
  • While the study tested both single and twice-daily doses of milvexian, the companies will wait to see the results from another Phase 2 trial in secondary stroke before deciding on a regimen. 
  • That readout is expected in 1H of 2022. There were no major bleeds in the milvexian arm compared to one in the enoxaparin arm. 
  • The major plus clinically relevant non-major bleeds (CRNM) rates were 0.8% and 1.4% in the milvexian and enoxaparin arms, respectively.
  • Price Action: BMY shares are up 0.43% at $59.69, and JNJ shares are down 0.55% at $164.10 during the market session on the last check Monday.
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