Bayer announces new late-breaking data from OCEANIC-STROKE trial of asundexian on the frequency, severity, and disability of ischemic strokes in patients after a[...]

Trial is on the frequency, severity, and disability of ischemic strokes in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack

KEY FINDINGS

• The Phase III OCEANIC-STROKE study, previously published in The New England Journal of Medicine, met the primary efficacy outcome of time to first occurrence of ischemic stroke and the primary safety outcome of time to ISTH (International Society on Thrombosis and Haemostasis) major bleeding
• New analyses from OCEANIC-STROKE trial evaluate stroke severity and disability in patients treated with investigational asundexian who experienced an ischemic stroke during the trial compared to placebo, both in combination with antiplatelet therapy
• In a new analysis, acute treatment with intravenous thrombolysis (IVT) / endovascular treatment (EVT) and fatality outcomes of incident ischemic strokes were examined in patients taking asundexian compared to placebo; the analysis provides interesting insights but was not designed to provide statistical confirmatory evidence

WHAT'S HAPPENING

WHIPPANY, N.J., May 6, 2026 - Bayer today announced late-breaking data from new analyses of the landmark Phase III OCEANIC-STROKE study of asundexian compared to placebo, both in combination with antiplatelet therapy. The study, presented at the European Stroke Organisation Conference (ESOC) 2026 in Maastricht, the Netherlands, analyzed the frequency, severity, and disability of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. Among patients who experienced an ischemic stroke during the study:

• The proportion of patients with a National Institutes of Health Stroke Scale (NIHSS) score ≥8 was lower with asundexian than placebo (22.9% vs 30.3%; p=0.045).
• Patients taking asundexian had numerically fewer disabling strokes (2.1% vs 3.0%; csHR 0.69; 95% CI 0.55-0.87) compared to placebo.

WHY THIS MATTERS
Stroke is the fifth leading cause of death in the United States.¹ Each year, approximately 795,000 people in the United States will experience a stroke. Of these, approximately 87% are ischemic and 23% are recurrent.² Despite current guideline recommended treatment options for stroke prevention, a significant proportion of survivors experience another stroke.^3,4 Approximately one in five stroke survivors will have another stroke within five years.⁴

OCEANIC-STROKE STUDY ANALYSES DESIGN

In OCEANIC-STROKE, 902 incident ischemic strokes occurred during the study (asundexian, n=384 [6.2%]; placebo, n=518 [8.4%]) and were evaluated for stroke severity and whether they were classified as disabling / fatal. Stroke severity was assessed using the National Institutes of Health Stroke Scale (NIHSS) during hospitalization and stratified by score (≤3, 4-7, and ≥8). Disabling stroke was defined as a modified Rankin Scale (mRS) ≥3 or a ≥1 point increase in mRS for patients with a baseline mRS ≥3.

KEY FINDINGS OF NEW ANALYSES FROM OCEANIC-STROKE TRIAL

• Stroke severity: Among incident ischemic strokes, moderate-to-high severity strokes (NIHSS ≥8) occurred in 88 patients (22.9%) in the asundexian group and 157 patients (30.3%) in the placebo group.
• Disabling / fatal stroke risk: The occurrence of disabling stroke was 2.1% (n=128) in the asundexian group and 3.0% (n=185) in the placebo group (csHR, 0.69; 95% CI: 0.55-0.87).
• Acute intervention: Of the ischemic strokes that did occur, 40 patients (10.4%) required acute intervention (intravenous thrombolysis [IVT] and/or endovascular treatment [EVT]) in the asundexian group, and 82 patients (15.8%) required acute intervention (IVT and / or EVT) in the placebo group.
• Ischemic stroke treated with EVT use: In patients who experienced an incident ischemic stroke, 27 patients (0.4%) required EVT in the asundexian group and 44 patients (0.7%) required EVT in the placebo group (csHR, 0.61; 95% CI: 0.38-0.99).
• Ischemic stroke with fatal outcomes: In patients who experienced an incident ischemic stroke, 16 patients (0.3%) experienced fatal outcomes in the asundexian group, and 28 patients (0.5%) experienced fatal outcomes in the placebo group (csHR, 0.57; 95% CI: 0.31-1.06).

BAYER EXECUTIVE COMMENT
"Stroke is one of the most pressing global health challenges, with serious and lasting consequences for patients, families, and healthcare systems around the world," said Sara Hegab, MD, VP, Stroke & Thrombosis, Specialty and Pipeline, U.S. Medical Affairs, Bayer. "OCEANIC-STROKE reflects the strength of Bayer's capabilities to take on complex global health challenges like stroke and the impact we hope to offer to patients. The insights from this study will continue to contribute to a deeper understanding of secondary stroke and the outcomes associated with these events."

About OCEANIC-STROKE
The Phase III OCEANIC-STROKE study investigated the efficacy and safety of the oral Factor XIa inhibitor asundexian 50 mg once-daily compared to placebo, both in combination with antiplatelet therapy, for prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). It is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that randomized 12,327 participants worldwide. The primary efficacy endpoint was time to first occurrence of ischemic stroke; the primary safety endpoint was time to ISTH major bleeding.

About FXIa
Factor XIa (FXIa) is a protein in the blood coagulation pathway, also known as the blood clotting process, with different roles in hemostasis (normal clotting to stop bleeding) and thrombosis (harmful clot formation that can block blood vessels). FXIa has a minor role in the formation of a hemostatic plug (a clot that seals a blood vessel injury) that seals the leak at the site of vessel injury. However, FXIa is thought to contribute to the formation of pathological thrombus growth (abnormal clot growth) and vessel blockage.

About Bayer's Commitment in Cardiovascular and Cerebrovascular Medicine
Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) and cerebrovascular diseases of high unmet medical need. We have set a clear focus on developing innovative therapies to treat such diseases (e.g., stroke, heart failure, cardiomyopathies, and chronic kidney disease) and it is our ambition to take a leading role in the care of patients with these diseases. Bayer is actively shaping the future of cardiology and neurology with a robust and diversified pipeline, strategically positioned to address critical unmet needs and drive significant long-term value. Bayer's portfolio already includes several 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 line with its mission, "Health for all, Hunger for none," the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.3 billion euros. R&D expenses amounted to 5.8 billion euros.

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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:

1. Martin SS, et al. Circulation. 2024;149(8):e347-e913.
2. Virani SS, et al. Circulation. 2021;143:e254-e743
3. Kolmos M, et al. J Stroke Cerebrovasc Dis. 2021;30(8):105935.
4. Lakshminarayan K, et al. Stroke. 2011;42(6):1556-1562.