Bayer Extends Clinical Development Program for KERENDIA® (finerenone) With Phase III Study to Investigate Use in Patients With Nondiabetic Chronic Kidney Disease

• The Phase III study FIND-CKD will investigate the effect of KERENDIA on kidney and cardiovascular outcomes in patients with nondiabetic chronic kidney disease¹

Bayer announced today the initiation of the FIND-CKD study, a multicenter, randomized, double-blind, placebo-controlled Phase III study for an investigational new use of KERENDIA^® (finerenone) in addition to guideline-directed therapy, on the progression of chronic kidney disease (CKD) in patients with nondiabetic CKD.¹ The primary objective of the study is to demonstrate superiority of finerenone over placebo in delaying the progression of CKD in these patients. The primary outcome measure is the mean rate of change in kidney function over time (estimated glomerular filtration rate [eGFR] slope) from baseline to month 32.¹

“In 2017, an alarming 1.2 million people died from chronic kidney disease worldwide.² Although diabetes is well-recognized as a leading cause of chronic kidney disease globally, a substantial proportion of the global burden is nondiabetic in origin and attributable to other causes, such as hypertension.^3,4 To improve outcomes, there is an urgent need for new treatments,”⁵ said Hiddo L. Heerspink, professor of clinical trials and personalized medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University Medical Center Groningen, Netherlands, and co-chair of the study’s executive committee. “If successful, this study could be of great significance to those living with chronic kidney disease globally.”

KERENDIA – a nonsteroidal mineralocorticoid receptor antagonist (MRA) – was approved in the United States on July 9, 2021, 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 CKD associated with type 2 diabetes (T2D).⁶ The KERENDIA label contains a Warning and Precaution that KERENDIA can cause hyperkalemia.⁶ For more information, see “Important Safety Information” below.

“KERENDIA has been studied so far in more than 13,000 patients through the comprehensive Phase III clinical trial program investigating kidney and cardiovascular outcomes in chronic kidney disease associated with type 2 diabetes, which demonstrated efficacy for finerenone versus placebo on top of standard of care,”^7,8 said Dr. Christian Rommel, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “The new FIND-CKD study extends our clinical research for KERENDIA to investigate a nondiabetic population where the unmet need is high for new treatments to delay disease progression.”

The planned Phase III FIND-CKD study will investigate finerenone compared to placebo in addition to standard of care in more than 1,500 patients with nondiabetic CKD etiologies, including hypertension and chronic glomerulonephritis (inflammation of the kidneys).¹ Patients will be randomized to receive either finerenone 10 mg or 20 mg or placebo on top of individually tolerated optimized doses of a renin-angiotensin system-blocking therapy such as an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker.¹

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)⁶

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

• Concomitant use with strong CYP3A4 inhibitors⁶
• Patients with adrenal insufficiency⁶

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/L⁶
  
  
  
  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 potassium⁶

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%)⁶

DRUG INTERACTIONS:

• Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice⁶
• 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 appropriate⁶
• Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers⁶

USE IN SPECIFIC POPULATIONS:

• Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment⁶
• 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)⁶

Please read the Prescribing Information for KERENDIA.

About Chronic Kidney Disease

CKD is a serious and progressive condition that is generally underrecognized.⁹ CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced.^10,11 In 2017, CKD affected an estimated 840 million people worldwide.¹² In the U.S., 1 in 3 adults is at risk for the disease.¹³ At advanced stages of CKD, patients may need dialysis or a kidney transplant to stay alive.¹⁴ Healthy kidneys act as the body’s filter, removing waste products from the blood.¹⁵ They also control how much water and electrolytes are in the body, regulating blood pressure.¹⁵ As kidney disease progresses toward kidney failure, patients may experience a range of symptoms including leg swelling, tiredness in the day, nausea, muscle cramps, joint pain and confusion, trouble focusing, memory problems.^14,16 Risk factors of CKD include diabetes and hypertension which can make it difficult to distinguish CKD from these conditions.¹⁷

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 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. A trial to learn how well finerenone works and how safe it is in adult participants with non-diabetic chronic kidney disease (FIND-CKD). ClinicalTrials.gov. Accessed September 17, 2021. https://clinicaltrials.gov/ct2/show/NCT05047263
2. GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020;395(10225):709-733. doi:10.1016/S0140-6736(20)30045-3
3. Webster AC, Nagler EV, Morton RL, Masson P. Chronic kidney disease. Lancet. 2017;389(10075):1238-1252. doi:10.1016/S0140-6736(16)32064-5
4. Mills KT, Stefanescu A, He J. The global epidemiology of hypertension. Nat Rev Nephrol. 2020;16(4):223-237. doi:10.1038/s41581-019-0244-2
5. Alicic RZ, Rooney MT, Tuttle KR. Diabetic kidney disease: challenges, progress, and possibilities. Clin J Am Soc Nephrol. 2017;12(12):2032-2045. doi:10.2215/CJN.11491116
6. KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; July 2021.
7. Bakris GL, Agarwal R, Anker SD, et al. Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes. N Engl J Med. 2020;383(23):2219-2229. doi:10.1056/NEJMoa2025845
8. Pitt B, Filippatos G, Agarwal R, et al. Cardiovascular events with finerenone in kidney disease and type 2 diabetes. N Engl J Med. 2021;10.1056/NEJMoa2110956
9. Breyer MD, Susztak K. Developing treatments for chronic kidney disease in the 21st century. Semin Nephrol. 2016;36(6):436-447. doi:10.1016/j.semnephrol.2016.08.001
10. Zhong J, Yang H-C, Fogo AB. A perspective on chronic kidney disease progression. Am J Physiol Renal Physiol. 2017;312(3):F375-F384. doi:10.1152/ajprenal.00266.2016
11. Khan YH, Mallhi TH, Sarriff A, Khan AH, Tanveer N. Prevalence of chronic kidney disease in Asia: A systematic review of population-based studies. J Coll Physicians Surg Pak. 2018;28(12):960-966. doi:10.29271/jcpsp.2018.12.960
12. Jager KJ, Kovesdy C, Langham R, Rosenberg M, Jha V, Zoccali C. A single number for advocacy and communication-worldwide more than 850 million individuals have kidney diseases. Kindey Int. 2019;96(5):1048-1050.
13. National Kidney Foundation. Are you the 33%? Accessed June 9, 2021. https://www.kidney.org/newsletter/are-you-33-percent
14. American Kidney Fund. Kidney failure (ESRD) causes, symptoms, & treatments. Accessed September 12, 2020. https://www.kidneyfund.org/kidney-disease/kidney-failure/
15. National Institute of Diabetes. 2020. Your kidneys & how they work. Accessed September 12, 2020. https://www.niddk.nih.gov/health-information/kidney-disease/kidneys-how-they-work
16. Kidney.org. Chronic kidney disease (CKD) symptoms and causes. 2020. Accessed September 12, 2020. https://www.kidney.org/atoz/content/about-chronic-kidney-disease
17. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int Suppl. 2013;3:1-150. https://kdigo.org/wp-content/uploads/2017/02/KDIGO_2012_CKD_GL.pdf

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