Bayer (OTC:BAYRY) has launched a new Phase III clinical study, OCEANIC-AFINA, to explore the effectiveness of asundexian (BAY2433334), an FXIa inhibitor, in patients aged 65 and above suffering from atrial fibrillation (AF) who are at high risk for stroke or systemic embolism but cannot undergo oral anticoagulant (OAC) treatment due to an elevated risk of ISTH major bleeding. This study is part of Bayer's OCEANIC clinical development program and follows the ongoing OCEANIC-AF study.
Asundexian is currently being evaluated as a possible treatment option in stroke prevention and thrombosis management. It is estimated that one-third of AF patients are either under-treated or not treated with oral anticoagulants, leading to a significant need for effective therapy that doesn't amplify the risk of bleeding during treatment. Asundexian could potentially address this need by providing protection from thrombotic events without a corresponding increase in bleeding risk.
The OCEANIC-AFINA study will pit the use of asundexian against a placebo in patients aged 65 and above with AF at high risk for stroke or systemic embolism who are ineligible for OAC treatment. The primary efficacy objective is to compare the time to first occurrence of ischemic stroke or systemic embolism between AF patients treated with asundexian or placebo. The primary safety objective is to describe the time to first occurrence of ISTH major bleeding in participants receiving asundexian and placebo.
The OCEANIC clinical trial program aims to evaluate the use of asundexian in patients with AF at risk of stroke and in patients following acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). The FDA has granted Fast Track Designation for asundexian for its potential to prevent stroke and systemic embolism in people with AF and for the prevention of stroke after an acute non-cardioembolic ischemic stroke.
Dr. Christian Rommel, Member of the Executive Committee of Bayer AG (ETR:BAYGN)'s Pharmaceutical Division, and Dr. Roxana Mehran, Professor of Medicine and Director of Interventional Cardiovascular Research and Clinical Trials at Icahn School at Mount Sinai, expressed optimism about asundexian's potential as an antithrombotic treatment for a broader range of patients.
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