Bayer to Present Data From Cardiovascular Portfolio, Including a Late-Breaking Presentation From FIDELITY for KERENDIA® (finerenone) and New Phase IIb Data From PACIFIC Trial Program for the Oral Factor XIa Inhibitor asundexian

• Late-breaking data from a new exploratory analysis of FIDELITY—a prespecified exploratory pooled analysis of the FIDELIO-DKD and FIGARO-DKD Phase III studies—investigates causes of mortality in patients with chronic kidney disease associated with type 2 diabetes treated with KERENDIA^® (finerenone) or placebo
• New Phase IIb data from PACIFIC trial program investigates the safety of investigational oral Factor XIa inhibitor asundexian (BAY 2433334) in stroke and acute myocardial infarction

Bayer will present a range of new clinical data at the European Society of Cardiology’s 70^th Annual Scientific Session (ESC.22) from August 26-29. Three late-breaking abstracts will be presented including data on the nonsteroidal mineralocorticoid receptor (MR) antagonist, KERENDIA^® (finerenone),¹ and the investigational oral Factor XIa inhibitor, asundexian. These data highlight Bayer’s ongoing commitment to patients with cardiovascular (CV) and kidney diseases.

Finerenone Prespecified Pooled Analysis FIDELITY Data

The prespecified exploratory pooled analysis FIDELITY, pools data from the FIDELIO-DKD and FIGARO-DKD Phase III studies, comprises data from more than 13,000 patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).²

A new exploratory analysis of FIDELITY, investigating causes of mortality in patients with CKD associated with T2D treated with finerenone or placebo, will be presented within the following late-breaking live-streamed session:

• Finerenone and effects on mortality in chronic kidney disease and type 2 diabetes: A FIDELITY analysis
  • Hot Line: Hot Line Session 8 – Important Clinical Trial Updates
  • August 29, 3:24-3:42 a.m. EDT

Additional sub-analysis from FIDELITY will evaluate whether CKD, as defined jointly by estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR), is a modifiable CV risk factor in patients with T2D. This sub-analysis will be presented during the following moderated ePosters session:

• In patients with type 2 diabetes chronic kidney disease is a modifiable cardiovascular risk factor
  • Moderated ePosters: Diabetes and the heart 2
  • August 27, 4:15-5:00 a.m. EDT

KERENDIA was approved in the United States based on the results of FIDELIO-DKD, to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, nonfatal myocardial infarction and hospitalization for heart failure in adult patients with CKD associated with T2D.¹ The KERENDIA label contains a Warning and Precaution that KERENDIA can cause hyperkalemia.¹ For more information, see Important Safety Information below.

Asundexian PACIFIC Phase IIb Study Data

The PACIFIC Phase IIb clinical program was designed to investigate if asundexian can reduce the risk of thrombotic events while minimizing additional bleeding risk. The PACIFIC Phase II clinical trial program consisted of three Phase IIb studies, each one focusing on one of the following medical conditions: atrial fibrillation (irregular heartbeat),³ a recent non-cardioembolic ischemic stroke⁴ or a recent acute myocardial infarction (heart attack).⁵

PACIFIC-AMI is a Phase IIb dose-finding trial which compares the investigational, oral FXIa inhibitor asundexian to placebo on top of standard dual antiplatelet therapy (DAPT) in patients following an acute myocardial infarction (AMI, or heart attack).⁵ The study was designed to evaluate the effect of several different doses of asundexian on safety (bleeding) and efficacy (cardiovascular death, myocardial infarction, stroke and stent thrombosis) versus placebo, on top of DAPT.⁵ The results of the study will be presented within the following late-breaker live-streamed session:

• PACIFIC-AMI - Efficacy and safety of factor XIa inhibitor asundexian on top of dual antiplatelet therapy after acute myocardial infarction
  • Hot Line: Hot Line Session 5
  • August 28, 2:52-4:14 a.m. EDT

PACIFIC-STROKE is a Phase IIb dose-finding trial designed to evaluate the effect of several different doses of asundexian on safety (bleeding) and efficacy on top of the standard anti-platelet therapy in patients following a non-cardioembolic ischemic stroke compared to a placebo.⁴ The results of the study will be presented within the following late-breaker live-streamed session:

• PACIFIC-STROKE - Phase II Program of AntiCoagulation via Inhibition of FXIa by the oral Compound BAY 2433334 – non-cardioembolic STROKE study
  • Hot Line: Hot Line Session 5
  • August 28, 6:14-6:36 a.m. EDT

In addition to the release of this study data, a joint session with ESC and The Lancet will review PACIFIC-AF, a Phase IIb dose-finding study comparing the safety (bleeding) of the oral FXIa inhibitor asundexian to the non-vitamin K antagonist oral anticoagulant (NOAC) apixaban in patients with irregular heartbeat (atrial fibrillation [AF]) who are at risk of stroke.³ The results were previously presented at the American College of Cardiology’s 71st Annual Scientific Session & Expo.

• Safety of the oral Factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF)
  • Official Joint Session: Recent features from The Lancet
  • August 29, 8:37-8:56 a.m. EDT

An additional poster presentation on the complete bioavailability of asundexian will also be presented during the congress:

• The complete bioavailability of asundexian is unaffected by tablet formulation, gastric pH, or food
  • Moderated ePosters: Vascular Biology and Physiology
  • August 29, 2:15-3:00 a.m. EDT

About KERENDIA (finerenone)

INDICATION:

• KERENDIA is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D)¹

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

• Concomitant use with strong CYP3A4 inhibitors¹
• Patients with adrenal insufficiency¹

WARNINGS AND PRECAUTIONS:

• Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5.0 mEq/L¹
  
  
  
  Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium¹

MOST COMMON ADVERSE REACTIONS:

• Adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo: hyperkalemia (18.3% vs. 9%), hypotension (4.8% vs. 3.4%), and hyponatremia (1.4% vs. 0.7%)¹

DRUG INTERACTIONS:

• Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice¹
• Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor and adjust KERENDIA dosage as appropriate¹
• Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers¹

USE IN SPECIFIC POPULATIONS:

• Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment¹
• Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B)¹

Please read the Prescribing Information for KERENDIA.

About Chronic Kidney Disease Associated With Type 2 Diabetes

Patients with CKD associated with T2D are three times more likely to die from a CV-related cause than those with T2D alone.⁶ CKD is a serious and progressive condition that is generally underrecognized.⁷ CKD is a frequent complication arising from T2D and is also an independent risk factor of CV disease.^8-10 Approximately 40% of all patients with T2D develop CKD.¹⁰ Despite guideline-directed therapies, patients with CKD associated with T2D remain at high risk of CKD progression and CV events.^8,9,11,12 T2D is the leading cause of end-stage kidney disease, which requires dialysis or a kidney transplant to stay alive.^13-15

About Factor XI and FXIa Inhibitors (asundexian)

Asundexian* (BAY2433334) is an investigational oral Factor XIa (FXIa) inhibitor (anti-thrombotic) and is part of a portfolio of assets targeting FXI or FXIa currently in clinical development by Bayer. Asundexian is currently being studied in the PACIFIC Phase IIb 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)³, a recent non-cardioembolic ischemic stroke⁴ or a recent myocardial infarction (heart attack).⁵ Asundexian is an investigational agent and has not been approved by any health authority for use in any country, for any indication.

More information about these trials is available at http://www.clinicaltrials.gov/. The National Clinical Trial numbers for these studies are PACIFIC-AF (atrial fibrillation) NCT04218266³, PACIFIC-STROKE (non-cardioembolic ischemic stroke) NCT04304508⁴ and PACIFIC-AMI (myocardial infarction) NCT04304534.⁵

*Asundexian is currently investigational and has not been approved for use in any country

About Bayer’s Commitment in Cardiovascular and Kidney Diseases

Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.

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.

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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. KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; July 2021.
2. Agarwal R, Filippatos G, Pitt B, et al. Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis. Eur Heart J. 2022;43(6):474-484.
3. ClinicalTrials.gov. Study to Gather Information About the Proper Dosing of the Oral FXIa Inhibitor BAY 2433334 and to Compare the Safety of the Study Drug to Apixaban, a Non-vitamin K Oral Anticoagulant (NOAC) in Patients With Irregular Heartbeat (Atrial Fibrillation) That Can Lead to Heart-related Complications. (PACIFIC-AF). 2020. Accessed March 2022. https://www.clinicaltrials.gov/ct2/show/NCT04218266
4. ClinicalTrials.gov. Study to Gather Information About Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following a Recent Non Cardioembolic Ischemic Stroke Which Occurs When a Blood Clot Has Formed Somewhere in the Human Body (But Not in the Heart) Travelled to the Brain. (PACIFIC-STROKE). 2020. Accessed March 2022. https://www.clinicaltrials.gov/ct2/show/NCT04304508
5. ClinicalTrials.gov. Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack (PACIFIC-AMI). 2020. Accessed March 2022. https://clinicaltrials.gov/ct2/show/NCT04304534
6. Afkarian M, Sachs MC, Kestenbaum B, et al. Kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephrol. 2013;24(2):302-308..
7. Breyer MD, et al. Developing treatments for chronic kidney disease in the 21st Century. Semin Nephrol. 2016. 2016;36(6):436-447.
8. Anders HJ, et al. CKD in diabetes: diabetic kidney disease versus nondiabetic kidney disease. Nat Rev Nephrol. 2018;14:361-377.
9. Thomas MC, et al. Diabetic kidney disease. Nat Rev Dis Primers. 2015;1:1-20.
10. Bailey R, et al. Chronic kidney disease in US adults with type 2 diabetes: an updated national estimate of prevalence based on Kidney Disease: Improving Global Outcomes (KDIGO) staging. BMC Res Notes. 2014;7(1):415. doi:10.1186/1756-0500-7-415.
11. KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2013;3:1-150.
12. American Diabetes Association standards of medical care in diabetes – 2021. Diabetes Care. 2021;44(1):1-244.
13. National diabetes statistics report 2020: estimates of diabetes and its burden in the United States. Centers for Disease Control and Prevention. Accessed July 9, 2021. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf
14. Stages of CKD. American Kidney Fund. Accessed May 11, 2021. https://www.kidneyfund.org/kidney-disease/chronic-kidney-disease-ckd/stages-of-chronic-kidney-disease/
15. United States Renal Data System. USRDS Annual data report. Volume 1: Chronic kidney disease. Chapter 6: Healthcare expenditures for persons with CKD. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. 2020. Accessed November 2021. https://adr.usrds.org/2020/chronic-kidney-disease/6-healthcare-expenditures-for-persons-with-ckd

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