Bayer says Asundexian showed 26% reduction in stroke in Phase III study

Bayer (BAYRY) presented the results from the global, pivotal Phase III OCEANIC-STROKE study evaluating the use of its investigational, once-daily, oral, Factor XIa inhibitor asundexian compared to placebo, both in combination with antiplatelet therapy. Asundexian reduced ischemic stroke by 26%, in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack, with no increase in the risk of ISTH major bleeding. These findings were consistent regardless of age or sex, index event, stroke subtype, NIHSS, and acute stroke therapy like thrombolysis or planned secondary prevention strategies SAPT or DAPT. The results were presented at the International Stroke Conference 2026 in New Orleans. OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor which demonstrated superiority in reducing recurrent ischemic stroke compared to placebo, Bayer said. Alongside the primary findings, secondary endpoints showed asundexian reduced the risk of a stroke of any kind by 26% compared to placebo. In addition, the following secondary efficacy endpoints were met for asundexian compared to placebo, both in combination with antiplatelet therapy: the composite endpoint of cardiovascular death, myocardial infarction or stroke, and the composite of death from any cause, MI or stroke. For the safety analyses, there was no increase in the rate of ISTH major bleeding between asundexian compared to placebo. For the pre-specified secondary safety endpoints, the risk of bleeding was similar compared to the rates seen in the placebo arm. Asundexian has 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.