Bayer Receives FDA Fast Track Designation for asundexian Stroke Program

Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment for secondary prevention in patients with a non-cardioembolic ischemic stroke.

Asundexian is an oral inhibitor of Factor Eleven (FXIa) ¹ that Bayer is developing as a potential treatment for secondary prevention in patients with a non-cardioembolic ischemic stroke as well as for two additional medical conditions: atrial fibrillation (irregular heartbeat) and recent myocardial infarction (heart attack). ^{2, 3, 4} Asundexian is currently in Phase II clinical trials in all three conditions either as a standalone therapy or in combination with anti-platelet therapy.

Fast Track Designation is intended to facilitate the development and expedite the review of drug candidates to treat serious medical conditions and fulfill unmet medical needs. The purpose of the program is to get important new therapeutics to the patient earlier. A drug candidate that receives Fast Track Designation may be eligible for more frequent interactions with the FDA to discuss the drug candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.⁵

“We are pleased that asundexian has received Fast Track Designation from the FDA, underscoring the urgent need for additional effective therapies to treat secondary stroke prevention,” said Hardi Mundl, M.D., group head thrombosis, clinical development and operations, Bayer. “This step aligns with Bayer’s long-standing commitment to advance a portfolio of treatment approaches for cardiovascular disease where significant medical need exists.”⁶

About asundexian* and FXIa Inhibitors

Asundexian (BAY2433334) is an oral Factor XIa (FXIa) inhibitor (anti-thrombotic) and is part of a portfolio of assets targeting FXI or FXIa inhibitors currently in clinical development by Bayer. Asundexian is currently being studied in the PACIFIC Phase II clinical trial program that consists of three Phase IIb studies in over 4,000 patients with one of the following three medical conditions: atrial fibrillation (irregular heartbeat), a recent non-cardioembolic ischemic stroke or a recent myocardial infarction (heart attack) ^7,8,9

More information about these trials is available at clinicaltrials.gov. The National Clinical Trial numbers for these studies are PACIFIC-AF (atrial fibrillation) NCT04218266, PACIFIC-STROKE NCT04304508 and PACIFIC-AMI (acute myocardial infarction) NCT04304534.

*Asundexian is an investigational agent and has not been approved by any health authority for use in any country for any indication.

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 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 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 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 Group or subgroup 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.

1. Thomas et al, Asundexian Phase I, Journal of Thromb Haemost, First evaluation of the safety, pharmacokinetics, and pharmacodynamics of BAY 2433334, a small molecule targeting coagulation factor XIa, accepted 28 June 2021, accessed 8 February 2022.

2. Clinicaltrials.gov, non-cardioembolic ischemic stroke (accessed 8 February 2022)

3. Clinicaltrials.gov, atrial fibrillation (accessed 8 February 2022)

4. Clinicaltrials.gov, recent myocardial infarction (accessed 8 February 2022)

5. www.fda.gov (accessed 8 February 2022)

6. Kubitza, Dagmar. Pharmacokinetics, pharmacodynamics and safety of BAY 2433334, a novel activated factor XI inhibitor, in healthy volunteers: A randomized phase 1 multiple-dose study. (accessed 8 February 2022)

7. Clinicaltrials.gov, non-cardioembolic ischemic stroke (accessed 8 February 2022)

8. Clinicaltrials.gov, atrial fibrillation (accessed 8 February 2022)

9. Clinicaltrials.gov, recent myocardial infarction (accessed 8 February 2022)

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