Novel anticoagulant asundexian initiates phase III clinical study to evaluate its efficacy in high-risk patients with atrial fibrillation and stroke or transient cerebral ischemia

On August 28, 2022, Bayer announced the initiation of the Phase III OCEANIC program to evaluate the efficacy of the oral factor XIa (FXIa) inhibitor asundexian in patients with atrial fibrillation and patients at high risk of non-cardiac ischemic stroke or transient cerebral ischemia sex and safety

Factor XI is a protein in the blood that is converted into the active enzyme form factor XIa during the coagulation cascade

The OCEANIC project was initiated based on the positive results of the Phase II PACIFIC study

Dr Ashkan Shoamanesh, Associate Professor of Medicine at McMaster University, said: "Worry about bleeding risk has led to many patients being treated poorly or not being optimally treated

"Direct oral anticoagulants have led to major advances in anticoagulation, but there are still patients who are not receiving treatment and need to prevent blood clots from forming," said Manesh Patel, Richard S.

Dr.

The OCEANIC Phase III clinical study program will begin with two large multinational studies, OCEANIC-AF and OCEANIC-STROKE, expected to enroll up to 30,000 patients in more than 40 countries

The OCEANIC-AF study will evaluate asundexian versus apixaban in patients with atrial fibrillation

The OCEANIC-STROKE study was a placebo-controlled study in patients at high risk for non-cardiac ischemic stroke or transient cerebral ischemia who were receiving standard antiplatelet therapy

These studies are evaluating whether the once-daily oral FXIa inhibitor asundexian can be a potential new treatment option for thrombosis prevention by selectively modulating the coagulation pathway

About Asundexian and FXIa Inhibitors

FXIa inhibitors specifically target proteins involved in pathological thrombosis, but do not affect pathways involved in the physiological healing of vessel wall injuries

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Following an Acute Heart Attack (PACIFIC-AMI),Piccini JP, Caso V, Connolly SJ et al.

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