Bristol-Myers Squibb Company (NYSE: BMY) today announced a worldwide collaboration with Janssen Pharmaceuticals, Inc. (Janssen) on a (FXIa) inhibitor program that includes the development and commercialization of Bristol-Myers Squibb’s Factor XIa (FXIa) inhibitor, BMS-986177, an investigational anticoagulant compound being studied for prevention and treatment of major thrombotic conditions. The companies are expected to advance BMS-986177 into Phase 2 clinical trials in the second half of 2018 for the study of secondary stroke prevention.
Factor XIa (FXIa) plays a key role in the activation and amplification of the coagulation cascade via the intrinsic pathway.i It was first noticed as a potential approach to thrombosis because people with little or no FXIa (Hemophilia C) show virtually no untoward bleeding in the absence of a major injury or surgery. Further, a small study of Hemophilia C patients showed a lower risk of stroke. Conversely, elevated levels of FXI /FXIa are a risk factor for stroke and venous thromboembolism.
Preclinical and early clinical studies suggest that selectively inhibiting the intrinsic branch of the coagulation cascade at an upstream protease such as FXIa could be a key strategy to reducing the risk of vascular events without increasing the risk of bleeding.