OCEANIC-AF, a phase III study investigating asundexian compared to apixaban (a direct oral anticoagulant) in patients with atrial fibrillation at risk for stroke is being stopped early. This decision is based on the recommendation of the study’s Independent Data Monitoring Committee (IDMC) as part of ongoing surveillance which showed an inferior efficacy of asundexian versus the control arm. Bayer will further analyze the data to understand the outcome and publish the data.
Available safety data are consistent with previously reported safety profiles of asundexian. The IDMC recommends continuing the OCEANIC-STROKE phase III study as planned.
Appropriate measures will be taken to close the OCEANIC-AF study and patients will be contacted by their treating physicians/investigators to discuss next steps.
“Although the results from this analysis do not support the continuation of the OCEANIC-AF study, we will continue investigating asundexian in the OCEANIC-STROKE study and are currently reevaluating other indications in patients in need of antithrombotic treatment,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development.
Other evidence suggests the benefit of anticoagulation therapy on top of standard of care in the population of the OCEANIC-STROKE study which lacks adequate treatment options.
Asundexian is an investigational agent and has not been approved by any health authority for use in any country, for any indication.
About the OCEANIC Program
The OCEANIC clinical trial program is designed to evaluate the use of asundexian, as an oral FXIa inhibitor, in patients with atrial fibrillation (AF) at risk of stroke and in patients following acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), aiming to improve the benefit-risk profile when compared to standard of care. The program consists of three large multinational studies, OCEANIC-AF, OCEANIC-STROKE and OCEANIC-AFINA. Patient recruitment for OCEANIC-AFINA has not yet started.