Bayer Expands Clinical Development Program Investigating Finerenone for Potential Treatment of Heart Failure

• Recruiting approximately 15,000 patients, MOONRAKER is expected to be one of the largest heart failure (HF) study programs to date^1,2,3,4
• Bayer continues to invest in the finerenone clinical development program and aims to investigate finerenone as a potential treatment for HF across a broad spectrum of patients and clinical settings

Bayer announced it is further investing in MOONRAKER— its clinical development program to investigate Kerendia^® (finerenone) as a potential treatment for heart failure (HF) — with the initiation of three additional investigator-sponsored collaborative studies.^1,2,3,4 Recruiting approximately 15,000 patients, MOONRAKER is expected to be one of the largest heart failure (HF) study programs to date.^1,2,3,4

The three additional studies are sponsored by CPC Clinical Research, a non-profit academic research organization affiliated with University of Colorado, which is conducting the studies in collaboration with other academic research organizations. The program is funded by Bayer. ^2,3,4

In addition to the ongoing Phase III study FINEARTS-HF, investigating finerenone versus placebo on top of standard of care (SoC) in more than 6,000 HF patients with mildly reduced or preserved ejection fraction,¹ the new studies will evaluate the efficacy and safety of finerenone in approximately 9,000 additional HF patients with reduced (HfrEF), mildly reduced (HfmrEF), and/or preserved ejection fraction (HfpEF).^2,3,4

“With the addition of the REDEFINE-HF, CONFIRMATION-HF and FINALITY-HF studies to the MOONRAKER heart failure clinical trial program, we aim to gain a comprehensive understanding of the potential of finerenone for the treatment of heart failure, examining its efficacy and safety across a broad spectrum of patients and clinical settings,” said Dr. Michael Devoy, Chief Medical Officer, Bayer. “The studies will complement our Phase III FINEARTS-HF study, and we hope the findings will provide additional guidance around the potential clinical implementation of finerenone.”

“Bayer is determined to drive research and innovations for patients that have the potential to expand treatment options in diseases of high unmet medical need,” said Robert Perkins, MD, Vice President, Cardiovascular & Renal, Bayer. “The newly added trials under MOONRAKER are designed to rigorously address common, important clinical scenarios for patients living with heart failure. Simply put—more needs to be done, and quickly. We are working to answer that call.”

About Kerendia^® (finerenone)

Kerendia is a non-steroidal mineralocorticoid receptor antagonist (MRA) and was approved by the FDA in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

Kerendia was studied in the largest CKD clinical trial program FIDELIO-DKD (Finerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) and FIGARO-DKD (Finerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) across a broad range of CKD severity in adults with CKD associated with T2D. In the finerenone Phase III program for CKD associated with T2D with over 13,000 people, FIDELIO-DKD and FIGARO-DKD showed finerenone reduced the risk of chronic kidney disease progression and cardiovascular events. Based on data from the clinical trial program, Kerendia has been recommended for adults with CKD associated with T2D in several major treatment guidelines, including the American Diabetes Association^® (ADA), the American Association of Clinical Endocrinology^®, and the Kidney Disease: Improving Global Outcomes^® (KDIGO) Foundation as well as the ADA/KDIGO Consensus Statement.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

• Concomitant use with strong CYP3A4 inhibitors
• Patients with adrenal insufficiency

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/L.
  
  
  
  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 potassium.

MOST COMMON ADVERSE REACTIONS:

• From the pooled data of 2 placebo-controlled studies, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% versus 6.9%), hypotension (4.6% versus 3.9%), and hyponatremia (1.3% versus 0.7%).

DRUG INTERACTIONS:

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

USE IN SPECIFIC POPULATIONS:

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

Please read the Prescribing Information for KERENDIA.

About MOONRAKER Heart Failure Clinical Trial Program

The MOONRAKER program with finerenone in patients with HF encompasses four Phase III studies:

• FINEARTS-HF, the ongoing randomized, parallel-group, double-blind, placebo-controlled, multicenter, event-driven Phase III study is evaluating the efficacy (including cardiovascular [CV] death and total HF events) and safety of finerenone versus placebo on top of SoC in patients suffering from HF with an ejection fraction of ≥40% (HFmrEF/HFpEF). ¹
• REDEFINE-HF is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study which will investigate efficacy and safety of finerenone versus placebo on top of SoC in reducing total (first and subsequent) HF events and CV death in approximately 5,200 patients who are currently hospitalized or recently discharged with a diagnosis of decompensated HF with an ejection fraction of ≥40% (HFmrEF/HFpEF). ²
• The Phase III study CONFIRMATION-HF is a randomized, controlled, open-label study to investigate finerenone in addition to an SGLT2-inhibitor compared to SoC in approximately 1,500 patients who have been hospitalized with HF (or recently discharged following a hospitalization for HF), independent of the LVEF. ³
• FINALITY-HF is a Phase III randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven study to investigate efficacy and safety of finerenone versus placebo on top of SoC in reducing CV death or HF events in approximately 2,600 patients with HF with an ejection fraction <40% (HFrEF) who are intolerant to or not eligible for treatment with a steroidal MRA such as spironolactone or eplerenone. ⁴

About Heart Failure

Heart failure (HF) is a highly prevalent chronic condition, affecting about 6.5 million adults in the U.S.⁵ HF is characterized by the progressive decline in the heart’s ability to pump enough blood to meet the body’s needs for blood and oxygen.⁵ Symptoms may include shortness of breath, fatigue, chest discomfort and swelling in the lower body. Risk factors are hypertension, diabetes mellitus, smoking, a past myocardial infarction, and coronary artery disease.^5,6

Patients with diabetes have more than two times the risk for developing heart disease than their healthier peers.⁷ Further, cardiovascular outcomes, hospitalization, and prognosis are worse for patients with diabetes mellitus relative to those without. While 10% to 15% of the general population have diabetes, a study suggests that 44% of patients hospitalized for HF have diabetes.⁷

About Bayer’s Commitment in Cardiovascular and Kidney Diseases

A leader in the cardiovascular (CV) space, Bayer upholds a long-standing commitment to delivering science for a better life by advancing research and treatment options.

Bayer’s cardiorenal franchise, which began with the discovery and development of a number of vital therapies, now includes a number of products and compounds in various stages of preclinical and clinical development with the potential to impact the way that CV and kidney diseases are treated.

Bayer is focused on advancing new treatment approaches for areas of high unmet medical need in CV and kidney diseases by identifying resources and programs aimed at better understanding the real-world management of chronic kidney disease (CKD), expanding screening and early care management for CKD, aligning with and supporting groups and institutions that share the common goals of improving health outcomes, promoting health literacy and education and promoting research and initiatives that represent the diversity required to address the needs of all patients.

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 driving sustainable development and generating 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 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 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 ClinicalTrials.gov. Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity & Mortality in Participants with Heart Failure and Left Ventricular Ejection Fraction Greater or Equal to 40% (FINEARTS-HF). 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT04435626.

² ClinicalTrials.gov. A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients (REDEFINE-HF). 2023. Available at: https://clinicaltrials.gov/study/NCT06008197?term=NCT06008197&rank=1.

³ Data on file.

⁴ Data on file.

⁵ Shah S. Heart failure (HF). MSD Manual Professional Version. 2019 Nov; 1-8.

⁶ Dunlay S et al. Risk factors for heart failure: A population-based case-control study. Am J Med. 2009 Nov; 122(11): 1023–1028.

⁷ Kenny HC, Abel ED. Heart Failure in Type 2 Diabetes Mellitus. Circ Res. 2019 Jan 4;124(1):121-141. doi: 10.1161/CIRCRESAHA.118.311371. PMID: 30605420; PMCID: PMC6447311.

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