Asundexian Reduces Recurrent Stroke Without Bleeding Risk: OCEANIC-STROKE

Asundexian (Bayer) significantly reduces the risk of ischemic stroke compared with placebo, without increasing the risk of major bleeding, when used for secondary stroke prevention in patients treated with background antiplatelet therapy, according to top-line results from OCEANIC-STROKE.

The large phase III study met its primary efficacy endpoint—the time to first occurrence of ischemic stroke—in approximately 12,300 patients with a history of noncardioembolic ischemic stroke or high-risk transient ischemic attack, drugmaker Bayer announced over the weekend.

In addition to cutting the risk of recurrent stroke, there was no significant increase in ISTH major bleeding.

The results are good news following disappointing findings when asundexian was used in the setting of atrial fibrillation (AF). The large OCEANIC-AF study comparing asundexian to apixaban (Eliquis; Bristol-Myers Squibb/Pfizer) was stopped early for lack of efficacy in patients with AF who were at risk for stroke.  

Asundexian is a reversible direct factor XIa inhibitor administered once daily. Factor XIa is considered a promising anticoagulation target because inhibiting it is believed to carry a lower risk of bleeding compared with the mechanisms of action of other oral anticoagulants—factor XIa contributes to clot progression and thrombosis but has less effect on hemostasis. There are also other factor XIa inhibitors in development, including abelacimab (Anthos Therapeutics) and milvexian (Bristol-Myers Squibb).

The full OCEANIC-STROKE results will be presented at an upcoming scientific congress, according to Bayer.