By Tristan Manalac

Pictured: Bayer's office in New Jersey

Bayer on Sunday announced it was stopping the Phase III OCEANIC-AF study ahead of schedule due to the disappointing performance of its investigational factor XIa inhibitor asundexian.
The decision to end OCEANIC-AF early is in line with the recommendation of an Independent Data Monitoring Committee, which during the ongoing surveillance of the study found that asundexian had “inferior efficacy” versus Bristol Myers Squibb’s and Pfizer’s Eliquis (apixaban). Bayer will take “appropriate measures” to close the study and will work with investigators to determine the next steps for patients.
Bayer did not provide specific data from OCEANIC-AF in its news release, but said it will continue to analyze its results and publish the findings.
Asundexian is an investigational inhibitor of the blood protein factor XIa, which is a key player in the coagulation cascade. The drug candidate is designed to be orally available and to act selectively on pathological clotting, allowing it to address episodes like stroke while also minimizing the risk of bleeding that is typically seen with standard anticoagulants.
Asundexian is Bayer’s challenge to BMS’s and Pfizer’s blockbuster blood thinner Eliquis. First approved in 2012 to cut the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF), Eliquis has become a multibillion-dollar asset for the two pharma powerhouses. In the third quarter of 2023 alone, Eliquis earned over $2.7 billion dollars worldwide for BMS, while Pfizer made nearly $1.5 billion in alliance revenues and direct sales.
In its bid to get asundexian to the market, the German multinational has launched a trifecta of Phase III studies assessing the factor XIa inhibitor in different cardiovascular indications. OCEANIC-AF, for instance, tried the drug in AF patients at risk of stroke.
Bayer is also evaluating asundexian’s therapeutic potential for AF in the OCEANIC-AFINA trial, which focuses on adults aged 65 years and older who are ineligible for oral anticoagulant treatment. This study is not yet recruiting and Bayer will reevaluate its design following the early end of OCEANIC-AF.
Beyond AF, Bayer is also running the OCEANIC-STROKE trial, a randomized, placebo-controlled, double-blinded, parallel-group and event-driven trial assessing asundexian for the prevention of ischemic stroke in patients following an acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack.
In the company’s statement, Christian Rommel, global head of Research and Development at Bayer, said that the pharma will “continue investigating asundexian in the OCEANIC-STROKE study.” The decision to stop OCEANIC-AF early will not affect the design and conduct of the stroke trial