Bayer Discontinues Phase III OCEANIC-AF Trial of Oral Factor XIa Inhibitor Asundexian Due to Insufficient Efficacy

On November 19, Bayer announced the early termination of the Phase III OCEANIC-AF study of asundexian for the prevention of stroke or systemic embolism in atrial fibrillation patients at risk of stroke. The reason was that the Independent Data Monitoring Committee (IDMC) found during data analysis that asundexian was less effective than the control group (apixaban).

However, the safety of asundexian in this study remained consistent with previous findings. Bayer also stated that it would further analyze the existing data to understand the specific situation, and the analysis results will be disclosed subsequently.

Asundexian is a novel oral Factor XIa inhibitor developed by Bayer. It targets Factor XIa (FXIa), which is involved in the blood coagulation process, thereby preventing pathological thrombosis. However, asundexian does not adversely affect normal physiological hemostasis and thus does not increase the bleeding risk associated with the current Standard of Care (SoC).

For asundexian, Bayer has launched two Phase III studies, the other being OCEANIC-STROKE. The OCEANIC-STROKE study aims to evaluate the efficacy and safety of asundexian in preventing ischemic stroke in patients with acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack. Additionally, Bayer announced earlier this month the initiation of a third Phase III study (OCEANIC-AFINA) to assess the efficacy and safety of the drug in preventing stroke in atrial fibrillation patients unsuitable for oral anticoagulant therapy. This study serves as a supplement to the OCEANIC-AF study.

In this analysis, the IDMC only recommended terminating the OCEANIC-AF study and suggested continuing the OCEANIC-STROKE study as planned. Regarding the OCEANIC-AFINA study, Bayer stated that it would reassess the rationality of its trial design.

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