Janssen, Bristol-Myers Squibb Team Up to Develop Therapy

Janssen Pharmaceuticals has teamed up with Bristol-Myers Squibb to drive BMS-986177, a Factor XIa (FXIa) inhibitor, into Phase II development for the study of secondary stroke prevention and major thrombotic conditions.

Early clinical research has shown that FXIa inhibition has the potential to reduce the risk of thrombotic events with a significantly lower risk of bleeding compared to currently available therapies. The research for thrombotic events will build upon work that BMS has conducted with Factor Xia programs in hemophilia C. In its announcement the company said Factor Xia plays a key role in the "activation and amplification of the coagulation cascade via the intrinsic pathway." The idea of using it as a potential approach to thrombosis came after a small study of Hemophilia C patients showed a lower risk of stroke. It was then understood that people with little or no FXIa (Hemophilia C) show virtually no untoward bleeding in the absence of a major injury or surgery, BMS said. Conversely, elevated levels of FXI /FXIa are a risk factor for stroke and venous thromboembolism, the company added.

Janssen, which developed the anticoagulant Xarelto, will pay Bristol-Myers Squibb an undisclosed amount of money in an upfront payment, as well as potential developmental and regulatory milestone payments. Development costs and commercial profits and losses will be shared between the two companies. In a joint announcement this morning the companies said they anticipate Phase II trials will begin in the second half of this year.

Tom Lynch, chief scientific officer at BMS, said the collaboration will leverage both companies’ resources and expertise to establish a broad development program across multiple indications. The companies will combine their expertise in thrombotic research to study the anti-coagulant BMS-986177 as a therapy in a number of cardiovascular conditions, including coronary artery disease, stroke and peripheral artery disease.

Janssen and BMS said the goal for next-generation anticoagulants such as BMS-986177 is to demonstrate similar or greater efficacy as the current standard of care. Additionally, the idea is to make improvements to lowering the risk of bleeding in patients. Early clinical research has shown that FXIa inhibition has the potential to reduce the risk of thrombotic events with a significantly lower risk of bleeding compared to currently available therapies, Janssen and BMS said in a joint statement.  

BMS and Janssen said combining their strengths and "extensive expertise" in cardiovascular treatments, they can maximize the potential of FXIa inhibition.

"With the addition of a Factor XIa inhibitor program to our pipeline, Janssen continues to live up to our long-standing commitment of working tirelessly to bring truly transformational therapies to patients worldwide. With this new collaboration we have the potential to improve the standard of care for patients with cardiovascular conditions characterized by pathologic thrombosis," Mathai Mammen, global head of Janssen Research & Development, said in a statement.

In October 2017 Janssen and another pharma giant partner Bayer halted a Phase III stroke prevention study following an interim analysis that showed Xarelto was not as effective in a certain patient population compared to a regimen of low-dose aspirin. Researchers were looking at expanding the use of the blood-thinner Xarelto as a preventative for a second stroke and systemic embolism in patients who experienced a recent embolic stroke of undetermined source. Xarelto has been approved for seven indications, including the treatment of pulmonary embolisms in adults and the treatment of deep vein thrombosis in adults.

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