Bayer Announces First Patients Enrolled in Global Phase III Studies for Investigational Oral FXIa Inhibitor Asundexian

• The OCEANIC program will investigate the efficacy and safety of asundexian (BAY2433334) in the prevention of stroke in patients with atrial fibrillation and also patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA)^1,2
• OCEANIC-AF and OCEANIC-STROKE are expected to enroll more than 27,000 patients in over 40 countries ³

Bayer today announced the first patients have been enrolled in the initial trials for its OCEANIC clinical trial program, designed to explore the use of asundexian (BAY2433334), an investigational oral Factor XIa (FXIa) inhibitor, in patients with atrial fibrillation (AF) and in patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), a temporary period of symptoms similar to those of a stroke.^1-2 Asundexian belongs to a potential new class of drugs being studied for thrombosis prevention.^1-2 OCEANIC is one of the largest Phase III endeavors Bayer has ever undertaken.³

OCEANIC-AF (Oral faCtor Eleven A iNhibitor asundexIan as novel antithrombotic - Atrial Fibrillation study) is a multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, two-arm study that will investigate asundexian compared to apixaban in patients with atrial fibrillation at risk for stroke.¹ The primary objectives of OCEANIC-AF are to determine the effects of asundexian on prevention of stroke and systemic embolism as well as compare the incidence of International Society on Thrombosis and Hemostatis (ISTH) major bleeding.¹ Its first patient was enrolled in December 2022.¹

“Despite advances in anticoagulation, potential bleeding risk may be a reason why some patients go untreated and underscores the need for alternative treatments to prevent thrombosis,”⁴ said Manesh Patel, M.D., Richard S. Stack Distinguished Professor, Chief of the Division of Cardiology and Co-Director of the Heart Center at Duke University, and Principal Investigator for the OCEANIC-AF trial. “The Phase III OCEANIC program will generate more data to advance our understanding of the safety and efficacy of asundexian across a large patient population.”^1-2

OCEANIC-STROKE (Oral faCtor Eleven A iNhibitor asundexIan as novel anti-thrombotiC - STROKE study) is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study on top of standard-of-care antiplatelet therapy in patients after a non-cardioembolic ischemic stroke or high-risk TIA.² The primary objectives are to investigate asundexian for prevention of ischemic stroke compared to placebo as well as compare the incidence of ISTH major bleeding.² Its first patient was enrolled in late January 2023.²

“Patients with acute non-cardioembolic stroke or transient ischemic attack have a high early risk of stroke that continues in the long term,”⁵ said Mike Sharma, M.D., MSc., FRCPC, Michael G. DeGroote Chair in Stroke Prevention and Medical Director of Stroke Program at McMaster University and Principal Investigator for the OCEANIC-STROKE trial. “Additional research into the combination of FXI inhibition and antiplatelet agents is needed to explore potential treatment options for the future.”

Combined, the trials are expected to enroll more than 27,000 patients in over 40 countries.^1-2

“Through our OCEANIC clinical trial program, Bayer leverages decades of cardiovascular expertise to investigate a potential new class of antithrombotics and explore the potential of asundexian as an additional antithrombotic treatment option across multiple patient populations,” ^1-2 said Maria Borentain, M.D., Vice President and Head of Thrombosis and Vascular Disease Clinical Development, Bayer. “The initiation of the OCEANIC program is based on insights from the PACIFIC Phase II program,³ which included PACIFIC-AF and PACIFIC-STROKE, and guided our decision to further explore the potential of asundexian in thrombosis management.”

The following abstracts on secondary analysis from the PACIFIC-STROKE study were selected for presentation at the International Stroke Conference, being held from February 8-10 in Dallas, Texas:

• Smith EE, Shoamanesh A, Mundl H, et al. Effect of factor XIa inhibition with asundexian on recurrent ischemic stroke according to baseline patterns of infarction on brain MRI: PACIFIC-Stroke.⁶
• Khatri P, Shoamanesh A, Mundl H, et al. Effects of the oral factor XIa inhibitor asundexian on intracranial bleeding among patients with acute non-cardioembolic ischemic stroke: PACIFIC-Stroke randomized trial. ⁷

About the FXIa Clinical Trial Program

The PACIFIC clinical trials form part of the broadest Phase IIb FXIa program in the world, involving more than 4,000 patients to date. ³

The OCEANIC Phase III clinical development program, currently underway, starts with two large multinational studies, OCEANIC-AF and OCEANIC-STROKE, expected to enroll more than 27,000 patients in over 40 countries. ^1-2 The program, one of the largest Phase III endeavors Bayer has ever undertaken, is part of Bayer’s commitment to address unmet needs in a growing range of underserved cardiovascular patient communities.

More information about these trials is available at http://www.clinicaltrials.gov/.

About Asundexian

Asundexian is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential once-daily oral Factor XIa (FXIa) inhibitor in thrombosis prevention. ^1-2

Factor XI is a protein in the blood that is converted into its active enzyme form (Factor XIa) as part of the blood coagulation cascade. ³

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its 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 drive sustainable development and generate 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 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.com.

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. ClinicalTrials.gov. A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke (OCEANIC-AF). Accessed Jan 31 2023. https://clinicaltrials.gov/ct2/show/NCT05643573
2. ClinicalTrials.gov. A Study to Learn More About Asundexian (Also Called BAY2433334) for Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older Who Already Had Such a Stroke Due to a Blood Clot That Formed Outside the Heart and Travelled to the Brain, or Temporary Stroke-like Symptoms (OCEANIC-STROKE). Accessed Jan 24 2022. https://clinicaltrials.gov/ct2/show/NCT05686070
3. Bayer Initiates Phase III Study Program for Investigational Oral fxia ... (no date). Available at: https://bayer2019tf.q4web.com/news/news-details/2022/Bayer-Initiates-Phase-III-Study-Program-for-Investigational-Oral-FXIa-Inhibitor-Asundexian/default.aspx. Accessed: January 31, 2023.
4. Maier, O. (2022). Asundexian Investor Webinar. https://www.bayer.com/sites/default/files/2022-08/Transcript%20Asundexian%20Investor%20Webinar%202022-08-29.pdf
5. Bhatia, K., Jain, V., Aggarwal, D., Vaduganathan, M., Arora, S., Hussain, Z., Uberoi, G., Tafur, A., Zhang, C., Ricciardi, M., & Qamar, A. (2021). Dual Antiplatelet Therapy Versus Aspirin in Patients With Stroke or Transient Ischemic Attack: Meta-Analysis of Randomized Controlled Trials. Stroke, 52(6). https://doi.org/10.1161/strokeaha.120.033033.
6. Data on file.
7. Data on file.

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