ESC Congress 2024: Bayer to Present Phase III KERENDIA® (finerenone) Data

• Hot Line Sessions to Feature Results from Investigational FINEARTS-HF Study in Heart Failure with Mildly Reduced or Preserved Ejection Fraction and Pooled, Exploratory Analysis from Three Pivotal Phase III Trials Exploring Finerenone on Cardio-Kidney Outcomes
• Detailed data from the Phase III FINEARTS-HF trial that investigated KERENDIA^® (finerenone) in patients with heart failure (HF) and LVEF ≥40% (left ventricular ejection fraction)¹ will be presented in a late-breaking “Hot Line” session at the European Society of Cardiology (ESC) Congress 2024
• Earlier this month, Bayer announced that the FINEARTS-HF trial met its primary endpoint and achieved a statistically significant reduction of the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits²
• Data from FINE-HEART, an integrated, pooled, exploratory, participant-level analysis across three pivotal Phase III clinical trials with finerenone— FINEARTS-HF, FIDELIO-DKD and FIGARO-DKD—designed to explore cardio-kidney outcomes in patients with HF with LVEF ≥40%, and/or chronic kidney disease (CKD) and type 2 diabetes (T2D),² will be presented in the same Hot Line session
• In addition to data from finerenone, data from the OCEANIC-AF Phase III trial investigating asundexian compared to apixaban, a direct oral anticoagulant, in patients with atrial fibrillation at risk of stroke³ will be presented

Bayer will present late-breaking Phase III data from the FINEARTS-HF trial investigating KERENDIA^® (finerenone) in patients with heart failure (HF) and LVEF ≥40% (left ventricular ejection fraction),¹ at the European Society of Cardiology (ESC) Congress 2024. Additionally, the company will present results from FINE-HEART, an integrated, pooled, participant-level analysis across three pivotal Phase III clinical trials with finerenone—FINEARTS-HF, FIDELIO-DKD and FIGARO-DKD—that explored cardio-kidney outcomes in patients with HF with LVEF ≥40%, and/or chronic kidney disease (CKD) and type 2 diabetes (T2D).²

Finerenone is marketed as KERENDIA^® and is currently approved to reduce the risk of cardiovascular death, hospitalization for HF, non-fatal myocardial infarction (MI), sustained eGFR decline and end-stage kidney disease in adult patients with CKD associated with T2D.⁴

FINEARTS-HF Data Presentation

• FINEARTS-HF - Finerenone in heart failure with mildly reduced and preserved ejection fraction
  • Hot Line 7, Session 11210
  • September 1, 2024, 6:00am EDT/11:00am BST

The randomized, double-blind, placebo-controlled, event-driven Phase III trial investigated the efficacy and safety of finerenone for the reduction of risk of cardiovascular death and HF events in patients with a diagnosis of symptomatic heart failure (New York Heart Association class II-IV) with a LVEF of ≥40%.¹ Approximately 6,000 patients were randomized to receive either finerenone or placebo once daily for up to 42 months.¹

Earlier this month, Bayer announced that the FINEARTS-HF trial met its primary endpoint and achieved a statistically significant reduction of the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits.²

KERENDIA is a non-steroidal, selective mineralocorticoid receptor antagonist (MRA) with established cardiovascular benefit (reduction in hospitalization for HF, CV death and non-fatal MI) in adults with CKD in T2D,⁴ and this new topline data provided positive results in a different patient population not limited to CKD in T2D— patients diagnosed with HF (LVEF ≥40).²

FINE-HEART Data Presentation²

• FINE-HEART - Participant-level pooled analysis of finerenone in heart failure and chronic kidney disease trials
  • Hot Line 7, Session 11210
  • September 1, 2024, 6:44am EDT/11:44am BST

FINE-HEART is an integrated, pooled, exploratory, participant-level analysis across three pivotal Phase III clinical trials with finerenone—FINEARTS-HF, FIDELIO-DKD and FIGARO-DKD— designed to explore its effect on cardio-kidney outcomes in patients with HF with LVEF ≥40%, and/or CKD and T2D.

OCEANIC-AF Data Presentation³

• OCEANIC-AF - Asundexian versus apixaban in patients with atrial fibrillation
  • Hot Line 6, Session 11209
  • September 1, 2024, 3:40am EDT/08:40 am BST

The OCEANIC-AF Phase III trial is designed to investigate asundexian compared to apixaban, a direct oral anticoagulant, in patients with atrial fibrillation at risk for stroke.³

Asundexian is an investigational agent and has not been approved by any health authority for use in any country for any indication.

About KERENDIA^® (finerenone)⁴

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 cardiovascular death, hospitalization for heart failure (HF), non-fatal myocardial infarction, sustained eGFR decline, and end-stage kidney disease and in adults with CKD associated with T2D.

In adults with CKD associated with T2D, finerenone has been recommended to reduce the risk of hospitalization for HF by the American Diabetes Association (ADA)⁵ and European Society of Cardiology (ESC).⁶

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 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 and non-diabetic chronic kidney disease (CKD).⁷

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.

Find more information at https://pharma.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 Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40% (FINEARTS-HF). Clinical trial registration No. NCT04435626. https://clinicaltrials.gov/study/NCT04435626. August 2024.

² Data on File.

3 A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke (OCEANIC-AF). Clinical trial registration No. NCT05643573. https://clinicaltrials.gov/study/NCT05643573. August 2024.

4 Bayer Pharmaceuticals. Kerendia (finerenone) [package insert]. U.S. Food and Drug Administration. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215341s000lbl.pdf. August 2024.

⁵ American Diabetes Association (Section 10: Cardiovascular disease and risk management: standards of care in diabetes—2024.) Diabetes Care. 2024;47(Suppl. 1):S179–S218. doi:10.2337/dc24-S010.

⁶ Marx N, et al. ESC Guidelines for the management of cardiovascular disease in patients with diabetes. Eur Heart J. 2023;44(39):4043-4140. doi:10.1093/eurheartj/ehad192.

⁷ Bayer Pharmaceuticals. Development Pipeline. U.S. Available at: https://www.bayer.com/en/pharma/development-pipeline. August 2024.

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