Bayer's Asundexian Meets Primary Endpoints in Phase III OCEANIC-STROKE Trial for Secondary Stroke Prevention
核心洞察
Bayer announced positive topline results from the Phase III OCEANIC-STROKE study, with asundexian significantly reducing ischemic stroke (搜索) risk compared to placebo in over 12,300 patients.
The once-daily oral Factor XIa (搜索) inhibitor demonstrated no increased risk of major bleeding when combined with antiplatelet therapy in secondary stroke prevention.
The study addresses a critical unmet need, as one in five stroke survivors experiences another stroke within five years despite current prevention options.
Bayer announced positive topline results from its global Phase III OCEANIC-STROKE study, demonstrating that asundexian, an investigational once-daily oral Factor XIa (搜索) (FXIa (搜索)) inhibitor, met both primary efficacy and safety endpoints for secondary stroke prevention. The study showed asundexian 50 mg once daily significantly reduced the risk of ischemic stroke (搜索) compared to placebo, both in combination with antiplatelet therapy, in patients after a non-cardioembolic ischemic stroke (搜索) or high-risk transient ischemic attack (搜索) (TIA).
Study Design and Patient Population
The OCEANIC-STROKE study was a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven trial that enrolled over 12,300 patients. The study investigated the efficacy and safety of asundexian 50 mg once daily compared to placebo for prevention of ischemic stroke (搜索) in patients after a non-cardioembolic ischemic stroke (搜索) or high-risk TIA, administered in combination with standard antiplatelet therapy.
Safety Profile Demonstrates No Increased Bleeding Risk
Critically, the study demonstrated no increase in the risk of International Society on Thrombosis and Haemostasis (ISTH) major bleeding in patients treated with asundexian compared to placebo, both in combination with antiplatelet therapy. This safety profile addresses a key concern with anticoagulation therapy in stroke prevention, where bleeding risk often limits treatment options.
Addressing Critical Unmet Medical Need
The results address a significant clinical challenge in stroke care. Each year, approximately 12 million people worldwide experience a stroke, with 20-30% being recurrent strokes. Despite available secondary stroke prevention options, the risk remains high, with one in five stroke survivors experiencing another stroke within five years. Stroke is the second leading cause of death globally, and recurrent ischemic strokes tend to be more disabling and carry higher mortality risk than first strokes.
"As clinicians, we see every day how devastating a recurrent stroke can be for patients and their families," said Mike Sharma, MD, principal investigator of the Population Health Research Institute (PHRI) OCEANIC-STROKE study and Senior Scientist at PHRI. "Even with currently available therapies, the risk of another stroke remains high, and each recurrence can have profound consequences. The topline results from OCEANIC-STROKE indicate that asundexian may become a new treatment option to reduce this risk – representing a potential major step forward in secondary stroke prevention."
Novel Mechanism of Action
Asundexian represents a novel approach to thrombosis prevention through Factor XIa (搜索) inhibition. Factor XIa is a protein in the blood coagulation pathway with different roles in hemostasis and thrombosis. While FXIa (搜索) has a minor role in forming hemostatic plugs that seal vessel injuries, it is thought to contribute significantly to pathological thrombus growth and vessel blockage. As a direct inhibitor of FXIa, asundexian is theorized to reduce thrombus formation that can lead to vessel stenosis or blockage without significantly increasing major bleeding risk.
Regulatory Status and Next Steps
Asundexian has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke (搜索). The compound remains investigational and has not been approved by any health authority for use in any country for any indication.
"We are excited by these positive topline findings which highlight the potential of Factor XIa (搜索) inhibition as a new way to help protect patients from a recurrent stroke," said Christian Rommel, Ph.D., Head of Research and Development at Bayer's Pharmaceuticals Division. "This marks an important milestone in Bayer's longstanding commitment to advancing innovation in thrombosis prevention."
Upcoming Data Presentations
Detailed results from the OCEANIC-STROKE study will be presented at an upcoming scientific congress. Bayer will also present methods and baseline characteristic data from the study at the 17th World Stroke Congress in Barcelona, Spain, from October 22-24, 2025. Additional presentations will feature real-world insights into risk factors and disease burden of non-cardioembolic ischemic stroke (搜索) across different countries through various observational studies including ASTRIS and ALTEA.