Bayer to Present Investigational Data from Comprehensive KERENDIA® (finerenone) Clinical Trial Program at Heart Failure 2024 Congress

Bayer will present Kerendia^® (finerenone) data from its comprehensive clinical trial program in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) in addition to data from FINEARTS-HF, the ongoing randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III study is investigating the efficacy (including CV death and total HF events) and safety of finerenone compared to placebo in patients suffering from symptomatic HF with an ejection fraction of ?40% (HFmrEF/HFpEF), at Heart Failure 2024, a scientific congress of the European Society of Cardiology (ESC), taking place May 11-14, 2024 in Lisbon, Portugal.

Finerenone is marketed as Kerendia^® and approved for the treatment of adults with CKD associated with T2D in more than 70 countries worldwide, including the United States. The abstracts may discuss a use outside of the approved indication.

Data will include a new pre-specified pooled analysis of three Phase III trials, FINE-HEART, with finerenone, insights around the overlapping nature of cardio-kidney-metabolic (CKM) conditions, additional risks associated with HF with LVEF ?40%, and the use of gamification to enhance clinical trial recruitment.

Details on select Bayer abstracts at the Congress are listed below:

Finerenone FINE-HEART study design and baseline characteristics:

• Abstract title: Design and baseline characteristics of FINE-HEART: an integrated pooled analysis of finerenone in >19,000 participants across 3 Phase III trials of HF & CKD
  • Late Breaking Science Session: Room 1; May 13, 2024; 4:06 a.m. EDT/9:06 a.m. WEST

Patient insights from finerenone FINEARTS-HF trial:

• Abstract title: Pain and anxiety in heart failure - findings from FINEARTS-HF
  • Moderated ePosters 3: May 11, 2024; 5:00 a.m. EDT/10:00 a.m. WEST
    
    

• Abstract title: Generalizability of the FINEARTS-HF trial to the U.S. population across the spectrum of kidney risk
  • Rapid Fire Abstract: Agora 2: May 11, 2024; 5:27 a.m. EDT/10:27 a.m. WEST
    
    

• Abstract title: Cardio-kidney-metabolic overlap in the FINEARTS-HF trial
  • Moderated ePosters 3: May 12, 2024; 8:00 a.m. EDT/1:00 p.m. WEST

Use of gamification in FINEARTS-HF study enrollment:

• Abstract title: A gamified behavioral science intervention to enhance trial enrollment: an embedded study within the FINEARTS-HF trial
  • ePosters Screen 5: May 11, 2024; 4:00 a.m. EDT/9:00 a.m. WEST

About Kerendia^® (finerenone)¹

Kerendia is a non-steroidal mineralocorticoid receptor antagonist (MRA) and was approved by the U.S. Food and Drug Administration (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 Kerendia Phase III program for CKD associated with T2D with over 13,000 people, FIDELIO-DKD and FIGARO-DKD showed Kerendia reduced the risk of CKD 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 those from 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 click here for full Prescribing Information for KERENDIA.

About Heart Failure

Heart failure (HF) is a highly prevalent chronic condition, affecting approximately 6.5 million adults in the U.S.² 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.² Symptoms can 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.^2,3

Patients with diabetes have more than two times the risk of developing HF than their healthier peers.⁴ Further, cardiovascular outcomes, hospitalization and prognosis are worse for patients with diabetes mellitus than those without. While 10% to 15% of the general population has diabetes, a study suggests that 44% of patients hospitalized for HF have diabetes.⁴

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 several 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 investigating potential treatment approaches for areas of high unmet medical need. Currently, Bayer is investigating nine CVR-related projects in different stages of development, including heart failure (HF), non-diabetic chronic kidney disease (CKD).

Bayer is actively identifying resources and programs aimed at better understanding the real-world management of 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. In line with its mission, "Health for all, Hunger for none," the company's 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 2023, the Group employed approximately 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 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.

¹ KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; September 2022.
² Fine N. Heart failure (HF). MSD Manual Professional Version. 2022 Sept.
³ Dunlay S et al. Risk factors for heart failure: A population-based case-control study. Am J Med. 2009 Nov; 122(11): 1023?1028.
⁴ 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.