Bayer’s oral FXIa inhibitor, asundexian, has met its primary efficacy and safety endpoints in a phase 3 study in secondary stroke prevention.
Asundexian is taken once daily as a 50 mg tablet in conjunction with antiplatelet therapy. In the OCEANIC-STROKE phase 3 trial — an international, randomized, placebo-controlled, double-blind, parallel group and event-driven 12,300-patient study — asundexian significantly reduced the risk of ischemic stroke compared to a placebo with antiplatelet therapy. The treatment also led to no increase in ISTH major bleeding rate.
Asundexian, a direct inhibitor of FXIa, is theorized to reduce thrombus formation that can lead to vessel stenosis or blockage, without a significant increase in major bleeding. It has been granted fast track designation by the FDA as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke. Bayer says it will now engage with global health authorities in preparation for the submission of marketing authorization applications and looks forward to presenting the results at an upcoming scientific congress.
This is first phase 3 study of factor XIa inhibitor that has concluded successfully. In contrast, BMS and J&J’s factor XIa inhibitor candidate, milvexian, showed earlier this month that it was unlikely to meet its primary endpoint in a late-stage study of acute coronary syndrome.