Bristol Myers Squibb and Johnson & Johnson have begun an educational campaign about the factor XIa pathway, laying the groundwork for a launch that could follow phase 3 readouts expected this year.
The partners are currently developing the factor XIa inhibitor milvexian. They ended a phase 3 trial of the investigational anticoagulant last year after concluding it was destined to fail, but two other pivotal trials, including a study in the large and potentially lucrative atrial fibrillation population, have continued and are on course to deliver data this year.
Ahead of the readouts, BMS and J&J have started an educational push called “Change the Target. Change What’s Possible,” they announced Tuesday. The campaign is designed to inform clinicians who manage cardiovascular and thromboembolic conditions about patients' unmet needs and how factor XIa inhibitors could address them.
The campaign website outlines gaps in care related to afib and stroke, the indications targeted in the active milvexian trials. Another section of the site shows the parts of the coagulation cascade—the process that results in the formation of stable blood clots—targeted by existing anticoagulants.
The discussions of the unmet need and treatment landscape tee up a video about the role of factor XIa in the coagulation cascade. Narrated by a physician specializing in thrombotic disorders, the film explains how inhibiting factor XIa could decouple hemostasis from thrombosis. Decoupling, which is central to the mechanism's appeal, could prevent dangerous clots without affecting bleeding risk.
“Despite advances in cardiovascular care, some patients with thromboembolic disease remain at high risk because current therapies may require difficult trade-offs between efficacy and bleeding,” Tania Small, M.D., head of medical affairs at BMS, said in the launch announcement. “A better understanding of the coagulation cascade has led to the identification of new targets, such as factor XIa, informing how we approach the research of thrombosis prevention while preserving healthy clotting.”
Convincing physicians that the mechanism at the heart of milvexian is differentiated could be important given the availability of alternatives in the key afib indication. BMS and Pfizer’s factor Xa inhibitor Eliquis, for one, is the comparator in the afib trial. Eliquis is set to lose U.S. patent protection in 2028, driving erosion of a key product for BMS and creating generic competitors to milvexian.
Meanwhile, at the American Stroke Association’s International Stroke Conference this week, Bayer is set to present phase 3 data on its own factor XIa inhibitor asundexian in secondary stroke prevention. The German drugmaker reported that the study hit its primary endpoint last year, boosting a program that was rocked by the early discontinuation of a phase 3 afib trial in 2023.