LEVERKUSEN (dpa-AFX) - Bayer AG (BAYZF.PK) late Sunday announced positive topline results from Phase III OCEANIC-STROKE study with its investigational, once daily, oral FXIa inhibitor asundexian, in secondary stroke prevention. The trial met its primary efficacy and safety endpoints.
The German pharmaceutical and biotechnology major said it plans to globally engage with health authorities in preparation for the submission of marketing authorization applications. The company also would present the detailed results at an upcoming scientific congress.
According to the firm, stroke is the second leading cause of death globally, and recurrent ischemic strokes tend to be more disabling and carry a higher mortality risk than the first stroke.
The study investigated the efficacy and safety of the oral Factor XIa inhibitor asundexian 50 mg once daily compared to placebo, for prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA) in combination with antiplatelet therapy.
The multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, has enrolled over 12,300 patients.
Bayer noted that OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor. The study demonstrated superiority of asundexian with antiplatelet therapy, showing significant reduction in ischemic stroke risk, without increasing ISTH major bleeding rate, compared to placebo with antiplatelet therapy.
In the trial, Asundexian 50 mg once daily significantly reduced the risk of ischemic stroke compared to placebo, both in combination with antiplatelet therapy, in patients after a non-cardioembolic ischemic stroke or high-risk ischemic attack.
Meanwhile, there was no increase in the risk of ISTH major bleeding in patients treated with asundexian compared to placebo, both in combination with antiplatelet therapy.
Christian Rommel, Head of Research and Development at Bayer's Pharmaceuticals Division, said, 'We are excited by these positive topline findings which highlight the potential of Factor XIa inhibition as a new way to help protect patients from a recurrent stroke. This marks an important milestone in Bayer's longstanding commitment to advancing innovation in thrombosis prevention.'
Bayer noted that Asundexian is an investigational compound and has not been approved by any health authority for use in any country for any indication. It has been been granted Fast Track Designation by the U.S. Food and Drug Administration as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke.
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