Phase III study of Asundexian in Atrial fibrillation stopped due to lack of efficacy: Bayer
Berlin: Bayer has announced that 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.
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