Bayer’s Asundexian Meets Primary Endpoints in OCEANIC-STROKE Trial for Secondary Stroke Prevention

OCEANIC-STROKE, Bayer’s Phase III Trial, Reveals Promising Results for Stroke Recurrence Prevention with Asundexian

• Groundbreaking OCEANIC-STROKE study demonstrates asundexian’s superiority in reducing ischemic stroke risk when paired with antiplatelet therapy, without elevating major bleeding rates based on ISTH criteria compared to placebo.
• The success of OCEANIC-STROKE marks a pivotal moment, representing the first successfully completed Phase III trial for a Factor XIa inhibitor.
• Bayer intends a global collaboration with health authorities to facilitate marketing authorization applications, with detailed results expected to be unveiled at an upcoming scientific congress.

BERLIN – Bayer has reported positive topline results from its global Phase III OCEANIC-STROKE trial, evaluating the investigational, once-daily, oral Factor XIa (FXIa) inhibitor, asundexian. The study achieved both its primary efficacy and safety endpoints.

The trial demonstrated that asundexian 50mg once daily significantly reduced the risk of ischemic stroke compared to placebo when both were administered in conjunction with antiplatelet therapy. This reduction was observed in patients who had experienced a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA).

Critically, the study found no increase in the risk of ISTH major bleeding in patients treated with asundexian compared to those receiving placebo, both in combination with antiplatelet therapy. Specific data from the OCEANIC-STROKE trial are slated for presentation at a forthcoming scientific congress, offering the medical community a deeper dive into the findings.

Stroke remains a significant global health challenge, with approximately 12 million people affected annually. Recurrent strokes account for 20-30% of all stroke events. Despite available secondary prevention strategies, the risk of another stroke remains substantial, with roughly one in five stroke survivors experiencing a recurrence within five years. Stroke is the second leading cause of death worldwide, and recurrent ischemic strokes are often more debilitating and carry a higher mortality rate than initial events.

“The current standard of care leaves a considerable unmet need in secondary stroke prevention,” commented Dr. Mike Sharma, principal investigator for the Population Health Research Institute (PHRI) OCEANIC-STROKE study. “The topline results from OCEANIC-STROKE suggest that asundexian has the potential to become a crucial new treatment option to reduce this risk. This could represent a significant advancement in the strategies to prevent secondary stroke events.”

“These positive findings reinforce the potential of Factor XIa inhibition as a therapeutic approach to protect patients from recurrent stroke,” stated Dr. Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division. “This achievement reflects Bayer’s longstanding commitment to innovation in thrombosis prevention, and we extend our gratitude to the investigators, patients, and colleagues who contributed to this critical milestone.”

The U.S. Food and Drug Administration (FDA) has granted Asundexian Fast Track Designation as a potential treatment for stroke prevention following a non-cardioembolic ischemic stroke. Notably, asundexian is an investigational compound and has not yet received approval from health authorities in any country.

OCEANIC-STROKE Study Details

The OCEANIC-STROKE trial evaluated the efficacy and safety of asundexian 50 mg administered once daily versus placebo in preventing ischemic stroke. Patients with a history of non-cardioembolic ischemic stroke or high-risk TIA received the study drug in combination with antiplatelet therapy.

This multicenter, international, randomized, placebo-controlled, double-blind, parallel-group, and event-driven study enrolled over 12,300 patients. The trial’s primary results are scheduled for presentation at an upcoming scientific congress.

FXIa Inhibitors and Asundexian: A Novel Approach to Thrombosis Prevention

Factor XIa (FXIa) is a key protein within the blood coagulation cascade, playing distinct roles in both hemostasis and thrombosis. While FXIa has a limited function in forming the hemostatic plug at the site of vessel injury, it contributes to pathological thrombus growth and vessel blockage.

Asundexian, a direct inhibitor of FXIa, aims to reduce thrombus formation that can lead to vessel stenosis or blockage, potentially without increasing major bleeding risk. Asundexian is under evaluation as a prospective treatment option in thrombosis prevention and is administered once daily as an oral investigational agent.

Bayer’s Commitment to Cardiovascular Health

Bayer holds a leading position in cardiology, focused on developing innovative treatments for cardiovascular diseases with high unmet medical needs. The company is investing in therapies for cardiovascular diseases such as stroke, heart failure, cardiomyopathies, and chronic kidney disease, aiming to drive long-term growth in precision cardiology.

Bayer is actively working to transform its portfolio into precision cardiology, addressing the burden of cardiovascular diseases and contributing to long-term growth. Bayer’s portfolio includes innovative products and compounds in various stages of preclinical and clinical development.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In fiscal 2024, the Group employed around 93,000 people and had sales of €46.6 billion. R&D expenses amounted to €6.2 billion.

For more information, visit www.bayer.com.

Source: Bayer