Bayer (BAYN) Study result summary

Unmet medical need and study background

• Stroke is a leading cause of death and disability, with high recurrence rates and limited advances in secondary prevention over the past two decades.

• Current standard of care relies on antiplatelet therapy, but recurrence rates remain unchanged.

• Asundexian, a once-daily oral Factor XIa inhibitor, was developed to address this gap and has completed a large phase III trial in secondary stroke prevention.

Study design and population

• OCEANIC-STROKE was a global, double-blind, placebo-controlled phase III trial with 12,327 randomized patients at 702 sites in 37 countries.

• Included adults with non-cardiomyopathic/non-cardioembolic ischemic stroke or high-risk TIA, planned for antiplatelet therapy, and enrolled within 72 hours of symptom onset.

• The population was diverse in age, sex, race, and stroke subtypes, with robust representation of large artery atherosclerosis, small vessel occlusion, and undetermined etiology.

• Enrolled all common stroke subtypes, classified by TOAST criteria, with broad representation of stroke etiologies.

• The trial aimed for generalizability to real-world clinical practice.

Efficacy and safety results

• Asundexian reduced the hazard of recurrent ischemic stroke by 26% compared to placebo, with early and sustained separation of event curves.

• Significant reductions were observed in all stroke, disabling/fatal stroke (31% reduction), and composite cardiovascular endpoints.

• No significant increase in ISTH major bleeding, intracranial hemorrhage, or minor bleeding was observed versus placebo.

• No increase in hemorrhagic stroke, symptomatic intracranial hemorrhage, or fatal bleeding was observed.

• The study is the first successful Phase III trial of a FXIa inhibitor to show superiority in reducing recurrent ischemic stroke.