Bayer (BAYN) Study result summary

Unmet medical need in secondary stroke prevention

• Stroke is a leading cause of death and disability, with high rates of recurrence and severe consequences for survivors.

• Current secondary prevention options have not advanced in over 20 years, leaving a significant unmet need.

• Second strokes are more deadly, disabling, and increase dementia risk.

• Stroke remains a major global health burden, with high rates of recurrence and mortality.

OCEANIC-STROKE trial design and population

• OCEANIC-STROKE was a global, double-blind, placebo-controlled phase III trial with 12,327 patients across 37 countries.

• Included adults with non-cardiomyopathic/non-cardioembolic ischemic stroke or high-risk TIA, randomized within 72 hours of symptom onset, all receiving antiplatelet therapy.

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

• Primary endpoint was time to ischemic stroke; primary safety endpoint was major bleeding.

• 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.

• Significant reductions were also seen in all stroke, disabling/fatal stroke (31% reduction), and major cardiovascular events.

• No significant increase in major, minor, or fatal bleeding, including intracranial hemorrhage, when combined with antiplatelet therapy.

• Secondary endpoints showed a 26% reduction in all types of stroke and significant reductions in composite cardiovascular outcomes.

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