Bayer Expands Finerenone Clinical Development Program with Three Phase III Studies for Finerenone in Patients with Diabetic Kidney Disease and Patients with Chronic Heart Failure

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Aug 31, 2015, 11:30 ET

WHIPPANY, N.J., Aug. 31, 2015 /PRNewswire/ -- Bayer HealthCare announced today the expansion of the clinical development program for its oral non-steroidal mineralocorticoid receptor antagonist finerenone (BAY 94-8862) with three Phase III studies. The studies will investigate the efficacy and safety of finerenone in patients with diabetic kidney disease, and in patients with chronic heart failure, with the first patients expected to be enrolled by the year-end.

It is estimated that more than seven million people in the U.S. suffer from diabetic kidney diseaseⁱ. Diabetic kidney disease is a common complication of diabetes and the most frequent cause of end-stage renal disease (ESRD) in Western countries. Diabetes causes more than 40 per cent of new cases of ESRDⁱⁱ. More than five million people in the U.S. suffer from chronic heart failure, and about half of people who develop heart failure die within five years of diagnosis.ⁱⁱⁱ

"The data we have seen for finerenone to date across the clinical development program make us very confident to move finerenone forward into Phase III across two important indications of high unmet medical need," said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development.

The initiation of the Phase III studies FIGARO-DKD and FIDELIO-DKD in diabetic kidney disease is based on data from the Phase IIb ARTS-DN study (NCT01874431)^iv, which was presented at the World Congress of Nephrology (WCN) in March this year. ARTS-DN included 823 patients with type 2 diabetes and the clinical diagnosis of diabetic nephropathy from 23 countries, who were treated for 90 days. The addition of once-daily oral finerenone to renin-angiotensin system (RAS)-blocking therapy resulted in a statistically significant reduction in change from baseline to day 90 in urine albumin-to-creatinine ratio (UACR) compared to placebo with the four highest doses of finerenone. The incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were comparable between all finerenone treatment groups and standard therapy. The duration of the study did not allow assessment of the long-term effects of finerenone on renal function or cardiovascular outcomes.

The Phase III program in Diabetic Kidney Disease (DKD) comprises two studies. FIGARO-DKD will investigate finerenone versus placebo in 6,400 patients with the clinical diagnosis of diabetic kidney disease mainly comprising of patients with high albuminuria (previously known as 'micro-albuminuria', defined as 300 mg/g > UACR >/= 30mg/g) while FIDELIO-DKD will investigate finerenone in comparison to placebo in 4,800 patients with the clinical diagnosis of diabetic kidney disease mainly comprising of patients with very high albuminuria (previously known as 'macro-albuminuria', defined as UACR >/= 300mg/g). Both studies will be conducted in about 40 countries including Europe, Japan, China and the US. Patients will receive finerenone or placebo on top of current standard of care, which includes RAS-blocking therapy such as angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs).

The initiation of the Phase III FINESSE-HF study in chronic heart failure is based on data from the exploratory Phase IIb ARTS-HF study (NCT01807221)^v, which was presented today in a Hot Line Session at ESC Congress Congress 2015 in London. ARTS-HF investigated the effects of different finerenone dosages compared to eplerenone in patients who presented in emergency departments with worsening chronic heart failure with reduced ejection fraction (HFrEF) and type 2 diabetes mellitus and/or chronic kidney disease. Finerenone showed a reduction of surrogate marker N-terminal prohormone B-type natriuretic peptide (NT-proBNP) comparable to eplerenone when comparing Day 90 to baseline. Exploratory endpoints of all cause death, cardiovascular hospitalization or emergency presentation for worsening chronic heart failure were lower with the finerenone dose that will be used in the phase III program, compared with eplerenone. The incidence of treatment-emergent adverse events (TEAEs) was similar between eplerenone and all finerenone dose groups.

The planned Phase III study FINESSE-HF will investigate finerenone compared to eplerenone in chronic heart failure patients with reduced ejection fraction and type 2 diabetes mellitus and/or chronic kidney disease across more than 35 countries, including Europe, Japan, China and the US. Patients will receive finerenone or eplerenone on top of standard medical treatment currently represented by angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blocker (ARBs) and β-blockers.

About Cardiology at Bayer
Bayer is committed to delivering Science For A Better Life by advancing a portfolio of innovative treatments. Cardiovascular diseases have become a severe problem in our society. Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular, lung and kidney diseases. 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 HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of around EUR 20.0 billion (2014), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 60,700 employees (Dec 31, 2014) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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.

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ⁱ http://www.cdc.gov/diabetes/pdfs/programs/fact-sheet-chronickidneydiseasekidneydiseasediabetes.pdf

ⁱⁱhttp://nccd.cdc.gov/CKD/default.aspx

ⁱⁱⁱ http://www.cdc.gov/DHDSP/data_statistics/fact_sheets/fs_heart_failure.htm

^iv https://clinicaltrials.gov/ct2/show/NCT01874431?term=arts-hf&rank=1

^v https://clinicaltrials.gov/ct2/show/NCT01807221?term=arts-hf&rank=1

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