Bayer Shares Rise as Stroke Prevention Drug Shows Promise

Bayer has reported positive topline results from its Phase III OCEANIC‑STROKE study of the experimental oral anticoagulant asundexian, showing that a daily 50 mg dose significantly reduced the risk of secondary ischemic stroke without increasing major bleeding. 

The trial enrolled more than 12,300 patients who had previously experienced a non‑cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA) and were already receiving antiplatelet therapy. 

This marks the first completed Phase III study of a Factor XIa inhibitor, a novel class of antithrombotic drugs.

According to Bayer, the risk of bleeding was not elevated: there was no increase in International Society on Thrombosis and Haemostasis (ISTH) major bleeding compared with placebo. 

Bayer said it plans to engage with global health authorities to pursue marketing authorization and will present the detailed results at an upcoming scientific congress. 

The company has previously said that the OCEANIC program represents one of its largest Phase III efforts.

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