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Befovacimab, an anti-tissue factor pathway inhibitor antibody: Early termination of the multiple-dose, dose-escalating Phase 2 study due to thrombosis.

Maria Elisa MancusoSheila J M InghamMarc Kunze
Published in: Haemophilia : the official journal of the World Federation of Hemophilia (2022)
Despite favourable initial results from preclinical and clinical studies, a positive safety profile of befovacimab was not confirmed. The lack of SAE-related laboratory abnormalities or differentiating PK/PD characteristics in participants experiencing SAEs raises concerns about the predictability of thrombosis following befovacimab treatment and emphasises the need for further investigation into the therapeutic window of anti-TFPI treatment.
Keyphrases
  • pulmonary embolism
  • randomized controlled trial
  • magnetic resonance imaging
  • computed tomography
  • bone marrow
  • mesenchymal stem cells
  • study protocol