Bristol Myers Squibb and Johnson & Johnson have decided to discontinue the phase 3 Librexia ACS trial for milvexian when added to the standard of care (conventional antiplatelet therapy) for patients after a recent acute coronary syndrome (ACS) event after determining that it is unlikely to meet its primary endpoint.
The decision to end the trial is based on an analysis from the Independent Data Monitoring Committee (IDMC). The IDMC concluded that milvexian would not significantly reduce the time to first occurrence of major adverse cardiovascular events compared to a placebo in patients who had recently suffered an acute coronary syndrome event. Patients would have taken milvexian along with conventional antiplatelet therapy.
Milvexian is an investigational, oral, highly-selective factor XIa (FXIa) inhibitor that prevents thrombosis at the same time as enabling hemostasis. Despite the decision to halt the Librexia ACS trial, it sill has the potential to redefine anticoagulant therapy and become a multi-billion-dollar asset. Since no safety concerns were identified, the Librexia AF (for patients with atrial fibrillation) and Librexia STROKE (for secondary stroke prevention) phase 3 trials will still take place. Data is expected in 2026.