Bristol Myers Squibb and Johnson & Johnson have discontinued a Phase 3 clinical trial of their next-generation blood thinner milvexian in patients with acute coronary syndrome, following an interim analysis that showed the drug was unlikely to meet its primary efficacy endpoint.
The pharmaceutical giants announced Friday that they are halting the Librexia ACS trial after an Independent Data Monitoring Committee determined the study would not achieve its primary goals. The trial was testing milvexian in patients who recently experienced an acute coronary syndrome event.
Drug Mechanism and Development Program
Milvexian is a selective factor XIa inhibitor designed to prevent harmful clotting in the blood. The drug represents a next-generation approach to anticoagulation therapy and has been closely watched by the medical community.
The Librexia clinical trial program encompasses three Phase 3 studies testing milvexian across different cardiovascular conditions. Beyond the now-discontinued ACS trial, the program includes Librexia AF for atrial fibrillation and Librexia STROKE for secondary stroke prevention.
Continuing Trials Show Promise
Despite the setback in acute coronary syndrome, the Independent Data Monitoring Committee recommended that the two remaining Phase 3 trials proceed as planned. Both the atrial fibrillation and secondary stroke prevention studies are expected to deliver topline results in 2026.
Clinical Context
Acute coronary syndrome is an umbrella term for situations in which blood flow to the heart muscle suddenly drops due to factors like blood clots or heart attacks. The condition represents a significant unmet medical need, making the failure of milvexian in this indication a notable disappointment for the cardiovascular medicine field.
The decision to halt the ACS trial while continuing the other studies suggests that milvexian's efficacy may be condition-specific, with potentially different outcomes across various cardiovascular applications.
