Finerenone significantly reduced renal and cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes

Data from Phase III FIDELIO-DKD study presented at the American Society of

Nephrology (ASN) Kidney Week 2020

Finerenone significantly reduced renal and cardiovascular outcomes in patients with chronic kidney disease and type 2

diabetes

• Finerenone is a first-in-class investigational non-steroidal, selective mineralocorticoid

receptor (MR) antagonist that demonstrated kidney and cardiovascular benefits in

patients with chronic kidney disease and type 2 diabetes1

• Finerenone specifically addresses MR overactivation, which is believed to be a key

contributor to disease progression2

• Despite guideline-directed therapies, patients with chronic kidney disease and type 2

diabetes remain at high risk of progression to kidney failure and cardiovascular

events3,4

• Results from the FIDELIO-DKD study were simultaneously published in the New

England Journal of Medicine

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FIDELIO-DKD is the first large contemporary positive outcomes study in patients with CKD and T2D with a primary composite endpoint exclusively consisting of kidney-specific outcomes. The findings from the FIDELIO-DKD study, which is part of the largest Phase III clinical trial program to date in CKD and T2D, were presented today at the American Society of Nephrology (ASN) Kidney Week 2020, and simultaneously published in the New England Journal of Medicine.

“Despite available treatments focusing on hemodynamic and metabolic pathways, there is residual risk of kidney disease progression in patients with chronic kidney disease and type 2 diabetes. The findings from FIDELIO-DKD provide important evidence suggesting a potential new strategy for treating these patients,” said Professor George L. Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and principal investigator of FIDELIO-DKD. “Overactivation of the mineralocorticoid receptor contributes to inflammation and fibrosis in the kidneys and heart, representing a promising target for a new therapy. New strategies are needed to prevent further end-organ damage and slow patients’ rate of decline in kidney function. The results with finerenone are highly relevant, showing improvement in outcomes for these patients who currently have limited options.”

The study showed that the effects of finerenone on the primary outcome were generally consistent across pre-specified subgroups, and the treatment effect was sustained throughout the duration of the study. Finerenone also significantly reduced the risk of the key secondary endpoint, a composite of time to cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for heart failure compared to placebo by 14% (relative risk reduction, HR 0.86 [95% CI, 0.75-0.99; p=0.0339]) over a median duration of follow-up of 2.6 years. Based on an absolute risk reduction of 2.4% at 36 months, the number needed to treat to prevent a key secondary CV outcome event was 42 [95% CI 22–397]. Patients in both groups received standard of care, including blood glucose lowering therapies and a maximum tolerated dose of a renin-angiotensin system- (RAS-) blocking therapy such as an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB).

“These vulnerable patients need to be protected by delaying the need for dialysis or a kidney transplant, and to reduce their risk of cardiovascular events,” said Dr. Joerg

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Moeller, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Research and Development. “There is a high unmet medical need in cardiovascular and kidney diseases, which we aim to address with our research and development efforts. The FIDELIO-DKD results demonstrate that finerenone may become a new potential therapeutic option for patients with chronic kidney disease and type 2 diabetes, who experience progressive loss of kidney function. We are pleased to have reached this important development milestone for finerenone that addresses a key driver involved in the progression of chronic kidney disease in type 2 diabetes.”

“A very common, long-term complication of diabetes, chronic kidney disease has a major impact on the lives of people living with type 2 diabetes, especially when it progresses to late stages. Moreover, treating end-stage kidney disease places a huge financial burden on the already overstretched NHS services,” said Dr. Mike Metcalfe, Director of Medical Affairs, General Medicine at Bayer UK. “Approximately 1.76 million patients with type 2 diabetes in the UK could go on to develop chronic kidney disease. These results are encouraging as they demonstrate the potential of finerenone as a novel treatment option for patients with type 2 diabetes when they are diagnosed with chronic kidney disease.’’

In FIDELIO-DKD, finerenone was well-tolerated, which is consistent with the safety profile seen in previous phase 2 studies.5-7 Overall treatment-emergent adverse events and serious adverse events were similar between groups. The majority of adverse events were mild or moderate. The frequency of serious adverse events was numerically lower in patients treated with finerenone (31.9%) compared to placebo (34.3%). Overall, hyperkalaemia-related adverse events occurred more often in patients receiving finerenone compared with placebo (18.3% and 9%, respectively). Hyperkalaemia-related serious adverse events were low (1.6% and 0.4%, respectively), and there was no hyperkalaemia-related death in either treatment group. Treatment was discontinued due to hyperkalaemia in 2.3% of patients treated with finerenone compared to 0.9% in the placebo group.

Bayer plans to submit applications for marketing authorization for finerenone for an indication in patients with chronic kidney disease and type 2 diabetes to health authorities by end of this year.