Bayer to Highlight New Cardiovascular and Renal Data at ACC.22, Including Late-Breaking Presentations for KERENDIA® (finerenone) as Well as Oral Factor XIa Inhibitor (asundexian) Program

WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer will present a range of new clinical data at the American College of Cardiology’s 71st Annual Scientific Session (ACC.22), being held April 2-4, 2022, in Washington, D.C. Data from KERENDIA^® (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA)¹ and asundexian, an investigational oral Factor XIa inhibitor² will be presented at the meeting. These data highlight Bayer’s ongoing commitment to patients with cardiovascular (CV) and kidney diseases.

Finerenone FIDELITY Prespecified Pooled Analysis Data

New data from FIDELITY, which explored the impact of finerenone on CV and kidney outcomes in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D), with and without history of CV disease, will be presented within the following late-breaking, live-streamed session:

• Finerenone and Cardiorenal Outcomes by History of Cardiovascular Disease in Patients With Type 2 Diabetes and Chronic Kidney Disease: FIDELITY Analyses³
  • Session 411 – Featured Clinical Research III
  • April 4, 2022, 1:00-1:10 p.m. (EDT)

The FIDELITY prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD combines the trial populations of patients with CKD (stages 1-4) associated with T2D.

Additional Finerenone Study Data

Also being presented is a new subgroup analysis of FIGARO-DKD and FIDELIO-DKD, investigating finerenone in relation to the population of the United States eligible for the treatment. These data will be shared during the following digital eAbstracts session:

• Generalizability of FIGARO-DKD And FIDELIO-DKD Trial Criteria to the United States Population Eligible for Finerenone⁴
  • Session 1187 – Prevention and Health Promotion: Diabetes and Cardiometabolic Disease Digital Presentations
  • April 2, 2022, 8:30 a.m. (EDT)

KERENDIA^® (finerenone) was approved on July 9, 2021 based on the results of the FIDELIO-DKD trial to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, non-fatal 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 Study Data

PACIFIC-AF—a multicenter, randomized, active comparator-controlled, double-blind, double-dummy, parallel group, dose-finding Phase II study—is the first head-to-head study to investigate the bleeding safety of an oral Factor XIa inhibitor versus a non-vitamin K oral anticoagulant (NOAC) in patients with atrial fibrillation (AF) who are at risk of stroke.² The study’s primary objective was number of participants with composite International Society of Thrombosis and Hemostasis (ISTH) major and clinically relevant non-major bleeding.² The additional purpose of this study was to try to find the best dose of asundexian to give to participants.² Results will be presented during the following Featured Clinical Research session:

• Multicenter, Randomized, Active Comparator-Controlled, Double-Blind, Double-Dummy, Parallel Group, Dose-Finding Phase 2 Study Comparing the Safety of the Oral FXIa Inhibitor Asundexian With Apixaban in Patients With Atrial Fibrillation: PACIFIC AF⁵
  • Session 407 – Featured Clinical Research II
  • April 3, 2022, 12:15-12:25 p.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.² 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)², a recent non-cardioembolic ischemic stroke¹⁶ or a recent myocardial infarction (heart attack)¹⁷. 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) NCT04218266², PACIFIC-STROKE (non-cardioembolic ischemic stroke) NCT04304508¹⁶ and PACIFIC-AMI (myocardial infarction) NCT04304534¹⁷.

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 new 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 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.

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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. 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
3. Filippatos G, et al. Finerenone and cardiorenal outcomes by history of cardiovascular disease in patients with type 2 diabetes and chronic kidney disease: FIDELITY analyses. Oral presentation at: ACC.22. April 4, 2022. Washington, D.C. https://www.abstractsonline.com/pp8/#!/10461/presentation/22134
4. Chiu N, et al. Generalizability of FIGARO-DKD and FIDELIO-DKD trial criteria to the United States population eligible for finerenone. Oral presentation at: ACC.22. April 2, 2022. Washington, D.C. https://www.abstractsonline.com/pp8/#!/10461/presentation/19787
5. Piccini JP, et al. Multicenter, randomized, active comparator-controlled, double-blind, double-dummy, parallel group, dose-finding phase 2 study comparing the safety of the oral FXIa inhibitor asundexian with apixaban in patients with atrial fibrillation: PACIFIC AF. Oral presentation at: ACC.22. April 3, 2022. Washington, D.C. https://www.abstractsonline.com/pp8/#!/10461/presentation/22128
6. Afkarian M, 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. https://care.diabetesjournals.org/content/diacare/suppl/2020/12/09/44.Supplement_1.DC1/DC_44_S1_final_copyright_stamped.pdf
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
16. 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
17. 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

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