BAYER AG
New post-hoc analyses from the prespecified pooled analysis FIDELITY will provide insights into the effects of finerenone on kidney and cardiovascular outcomes by use of glucagon-like peptide-1 receptor agonists (GLP-1RA) at baseline, as well as by baseline HbA1c, HbA1c variability, and diabetes duration in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) / An exploratory subgroup analysis of FIDELITY will reveal further insights into the efficacy and safety of finerenone in CKD and T2D patients with obesity, as defined by a substantially increased waist-hip ratio / The Phase II CONFIDENCE study design will be presented, investigating simultaneous initial combination therapy with finerenone and an SGLT2-inhibitor in patients with CKD and T2D
Berlin, September 20, 2022 - Bayer will present new renal and cardiovascular data from the comprehensive Kerendia™ (finerenone) clinical trial program at the 58th Annual Meeting of the European Association for the Study of Diabetes (EASD) 2022. This data will include new post-hoc analyses of FIDELITY, a prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD, as well as the design of the Phase II CONFIDENCE study, investigating simultaneous initial combination therapy with finerenone and an SGLT2-inhibitor in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).
Kerendia FIDELITY study data:
The prespecified pooled analysis FIDELITY, including the FIDELIO-DKD and FIGARO-DKD studies, comprises data in >13,000 patients with CKD and T2D. FIDELITY investigated the efficacy and safety of Kerendia across a broad range of patients with early to late-stage CKD and T2D and provided insights into the relationship between CKD stage (based on baseline Kidney Disease: Improving Global Outcomes - KDIGO - risk categories) and the effects of Kerendia on composite CV and kidney-specific endpoints.
Data from a new post-hoc analysis from FIDELITY evaluated the effects of Kerendia on kidney and CV outcomes by use of glucagon-like peptide-1 receptor agonists (GLP-1RA) at baseline. This analysis encompasses a population including patients with earlier stages of CKD than was included in the FIDELIO-DKD trial.
· Finerenone in patients across the spectrum of CKD and type 2 diabetes by GLP-1RA use
o Short Oral Discussion Area 8
o September 20, 2022; 1:00 - 2:00pm (CEST)
An additional post-hoc analysis from FIDELITY will investigate the effect of Kerendia by baseline HbA1c categories, HbA1c variability, and diabetes duration in patients with CKD and T2D. Despite well-controlled blood glucose levels and blood pressure, many patients with CKD and diabetes still progress to loss of kidney function. New therapeutic strategies are needed to prevent further end-organ damage and slow patient's rate of decline in kidney function.
· Effects of finerenone in patients with chronic kidney disease and type 2 diabetes are independent of HbA1c at baseline, HbA1c variability and duration of diabetes
o Short Oral Discussion Area 8
o September 22, 2022; 12:00 - 1:00pm (CEST)
Further data from FIDELITY will investigate the efficacy and safety of Kerendia in CKD and T2D patients with obesity, as defined by a substantially increased waist-hip ratio. Kerendia is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and CV outcomes in patients with CKD and T2D. Patients with visceral adiposity have been shown previously to respond better to MR antagonists than patients without visceral adiposity.
· Cardiorenal and safety outcomes with finerenone in patients with obesity, CKD and type 2 diabetes
o Short Oral Discussion Area 8
o September 22, 2022; 12:00 - 1:00pm (CEST)
Finerenone CONFIDENCE study design:
Bayer will also present the design of the Phase II CONFIDENCE study, investigating simultaneous initial combination therapy with finerenone and an SGLT2-inhibitor in patients with CKD and T2D. Despite guideline-directed therapies, patients with CKD and T2D remain at high risk of CKD progression and CV events. It is currently unknown whether dual therapy with finerenone and a SGLT2i is superior to either agent alone. The CONFIDENCE study aims to address this clinical question.
· Design of the COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using an UACR Endpoint study (CONFIDENCE)
o Short Oral Discussion Area 11
o September 21, 2022; 1:15 - 2:15pm (CEST)
About Kerendia™ (finerenone)
Kerendia is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.
Based on the positive results of the FIDELIO-DKD Phase III study, Kerendia™ was granted marketing authorization by the U.S. Food and Drug Administration (FDA) in July 2021, the European Commission in February 2022, and the Chinese National Medical Products Administration (NMPA) in June 2022. In September 2022, Bayer announced that it received approval from the U.S. FDA for a label update for Kerendia™ to include findings from the Phase III FIGARO-DKD CV outcomes study. In March 2022, Bayer submitted a Type II Variation application based on the data from FIGARO-DKD to the European Medicines Agency (EMA) to seek an extension of the marketing authorization for Kerendia™ to include early stages of CKD associated with T2D. Based on the positive results of both pivotal Phase III studies, FIDELIO-DKD and FIGARO-DKD, Kerendia™ was approved in March 2022 by the Japanese Ministry of Health, Labour, and Welfare (MHLW). Further regulatory approvals by other health authorities in multiple other countries have been granted or are currently pending following submissions for marketing authorization.
The Phase III study programme with finerenone, FINEOVATE, currently comprises five Phase III studies, FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF, FIND-CKD, and FIONA, as well as the Phase II study CONFIDENCE.
Having randomized more than 13,000 patients with CKD and T2D around the world, the Phase III program with finerenone in CKD and T2D comprises two completed and published studies, evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes. FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and T2D.FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of cardiovascular morbidity and mortality in approximately 7,400 patients with CKD and T2D.
FIDELITY (FInerenone in chronic kiDney diseasE and type 2 diabetes: Combined FIDELIO-DKD and FIGARO-DKD Trial programme analYsis), including the FIDELIO-DKD and FIGARO-DKD studies, comprises the largest Phase III cardiorenal outcomes clinical trial program in >13,000 patients with CKD and T2D.The prespecified FIDELITY pooled analysis investigated the efficacy and safety of finerenone across the spectrum of patients with CKD in T2D in reducing the risk of chronic kidney disease progression as well as fatal and nonfatal CV events and provided insights into the relationship between CKD stage (based on baseline Kidney Disease: Improving Global Outcomes - KDIGO - risk categories) and the effects of finerenone on composite cardiovascular and kidney-specific endpoints.
In November 2021, Bayer announced the initiation of FIONA, a multicenter, randomized, double-blind, placebo-controlled Phase III study, to investigate the efficacy, safety, and pharmacokinetics/pharmacodynamics (PK/PD) of finerenone, in addition to standard of care, in approximately 200 pediatric patients with chronic kidney disease (CKD) and severely increased proteinuria.
In September 2021, Bayer announced the initiation of the Phase III study FIND-CKD, a multicenter, randomized, double-blind, placebo-controlled Phase III study to investigate the efficacy and safety of finerenone in addition to guideline-directed therapy on the progression of chronic kidney disease (CKD) in more than 1,500 patients with non-diabetic chronic kidney disease etiologies, including hypertension and chronic glomerulonephritis (inflammation of the kidneys).
In June 2020, Bayer announced the initiation of the FINEARTS-HF study, a multicenter, randomized, double-blind, placebo-controlled Phase III study which will investigate finerenone compared to placebo in approximately 6000 patients with symptomatic heart failure (New York Heart Association class II-IV) with preserved ejection fraction, i.e., a left ventricular ejection fraction of ≥40%.The primary objective of the study is to demonstrate superiority of finerenone over placebo in reducing the rate of the composite endpoint of cardiovascular death and total (first and recurrent) heart failure (HF) events (defined as hospitalizations for HF or urgent HF visits).
In February 2022, Bayer announced the initiation of the CONFIDENCE study, a Phase II, three-arm study that will investigate simultaneous initial combination therapy with finerenone and the SGLT2 inhibitor empagliflozin, compared with finerenone alone and empagliflozin alone respectively in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). The primary objective of the study is to investigate if the simultaneous initiation and combined use of finerenone and empagliflozin is superior to either empagliflozin alone, or finerenone alone, in reducing urine albumin-to-creatinine ratio (UACR).
About Chronic Kidney Disease in Type 2 Diabetes
Chronic kidney disease (CKD) is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease. Up to 40% of all patients with type 2 diabetes develop chronic kidney disease. Despite guideline-directed therapies, patients with CKD and T2D remain at high risk of CKD progression and cardiovascular events. It is estimated that CKD affects more than 160 million people with T2D worldwide. Chronic kidney disease in type 2 diabetes is the main cause of end stage kidney disease, which requires dialysis or a kidney transplant to stay alive.Patients with chronic kidney disease and type 2 diabetesare three times more likely to die from a cardiovascular-related cause than those with type 2 diabetes alone.
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 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 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go towww.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 atwww.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conformthem to future events or developments.
Dr. Daniela Esser
Cardiology
daniela.esser@bayer.com
+49 30 2215-41588
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Bayer AG published this content on 20 September 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 06 October 2022 11:01:07 UTC.
