Phase II misses don’t stop Bayer, BMS from advancing Factor XIa inhibitors

A pair of Phase II misses for the most advanced oral Factor XIa inhibitors in development — milvexian from BMS and Janssen, and asundexian from Bayer — raises questions about whether the therapeutic class can deliver on its promise of preventing thrombotic events without elevating bleeding risk, but that’s not stopping the sponsors from moving forward with Phase III studies.

In data presented Sunday at the European Society of Cardiology (ESC) Congress, both therapies, which are intended to reduce secondary thrombotic events after infarction, succeeded in avoiding an increase in severe bleeding events, but fell short on efficacy...