August 31, 2015
Bayer Expands Finerenone Clinical Development Programme with Three Phase III Studies in Patients with Chronic Heart Failure and Patients with Diabetic Kidney Disease
Decision based on data of four dose-finding studies in patients with chronic heart failure and diabetic kidney diseaseBerlin, August 31, 2015 - Bayer HealthCare announced today the expansion of the
clinical development programme for its novel, oral, non-steroidal
mineralocorticoid receptor antagonist (MRA) finerenone (BAY 94-8862) with three
Phase III studies. The studies will investigate the efficacy and safety of
finerenone in patients with chronic heart failure (CHF) and patients with
diabetic kidney disease (DKD) with the first patients expected to be enrolled
by the year-end. Despite recent advances, chronic heart failure is still a
deadly disease with 5-years survival rates similar to those of patients with
advanced cancer. 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 ESRD.
"The data we have seen for finerenone to date across the clinical development
programme 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. "We are excited about finerenone being the first mineralocorticoid
receptor antagonist that is being developed in parallel in chronic heart
failure and diabetic kidney disease. The studies will investigate whether
finerenone can reduce cardiovascular morbidity and mortality as well as the
progression of renal disease in these patients with a well-tolerated safety
The initiation of the Phase III FINESSE-HF study in chronic heart failure is
based on promising data from the exploratory Phase IIb ARTS-HF study, which was
presented today in a Hot Line Session at ESC Congress 2015 in London. ARTS-HF
investigated the effects of different finerenone dosages compared to eplerenone
in patients 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 NT-proBNP comparable to highly effective
eplerenone when comparing Day 90 to baseline while demonstrating meaningful
reductions in key exploratory endpoints of all-cause death and cardiovascular
hospitalization versus eplerenone with the lowest incidence observed in the
finerenone 10/20 mg dose group. All doses of finerenone were well-tolerated and
incidences of treatment-emergent adverse events (TEAEs) were similar between
eplerenone and all finerenone dose groups. ARTS-HF involved a total of 1,055
patients across 25 countries.
The planned Phase III study, FINESSE-HF, will investigate finerenone compared
to eplerenone in more than 3,600 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 ?-blockers.
The initiation of the Phase III studies FIGARO-DKD and FIDELIO-DKD in diabetic
kidney disease is based on promising data from the Phase IIb ARTS-DN study,
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 kidney disease from 23 countries, who were treated for 90
days. The addition of once-daily oral finerenone to RAS-blocking therapy
resulted in a significant reduction of albuminuria without adversely affecting
serum potassium or kidney function compared with placebo on top of RAS-blocking
therapy. All finerenone doses were well-tolerated and incidences of
treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
were comparable between all finerenone treatment groups and standard therapy.
The Phase III programme in 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 Urine
Albumin-to-Creatinine Ratio (UACR) ? 30mg/g and < 300mg/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 U.S. Patients will receive finerenone or placebo
on top of current standard of care, which includes RAS-blocking therapy such as
ACE inhibitors or ARBs.
Finerenone (BAY 94-8862) is a novel potent and selective oral non-steroidal
mineralocorticoid receptor antagonist (MRA) blocking deleterious effects of
mineralocorticoid receptor (MR) over-activation by aldosterone. Increased
activation of the MR leads to pathological changes in the heart and kidneys,
which can be prevented by effective blockade of the MR. Current steroidal MRAs
on the market have proven to be effective in reducing cardiovascular mortality
in patients suffering from heart failure with reduced ejection fraction
(HFrEF). However, they are often underutilized due to the incidence of
hyperkalemia, renal dysfunction, and anti-androgenic / progestogenic side
effects. Finerenone, a third-generation MRA, has demonstrated a promising
efficacy and safety profile in preclinical studies as well as in Phase I and
Phase II clinical trials.
About Heart Failure
The prevalence of heart failure has increased progressively over the past
several decades owing primarily to a reduction in myocardial infarction
mortality and a steady ageing of the population around the world. When
categorized by ejection fraction, heart failure is divided into two different
forms: heart failure with reduced ejection fraction (HFrEF), formerly known as
systolic heart failure, is characterized by the compromised ability of the
heart to eject oxygen rich blood sufficiently during its contraction phase.
HFrEF is a final common pathway for many cardiovascular diseases, notably
coronary artery disease. Once established, HFrEF progresses through activation
of a variety of pathways that adversely affect cardiac structure and function.
Currently, the most effective pharmacological therapies for HFrEF target the
over-activation of the renin-angiotensin-aldosterone system and the ?-
adrenergic sympathetic nervous system that occurs in heart failure. However,
even with the current treatment options, morbidity and mortality remain high
and increase further after episodes of acute decompensation or hospitalization.
The other form of heart failure is heart failure with preserved ejection
fraction (HFpEF), previously known as diastolic heart failure, a condition
characterized by stiffness of the heart leading to filling abnormalities and
increased pressure in the heart. There is no treatment currently approved for
About Diabetic Kidney Disease
Continuously increased sugar levels in the blood of diabetic patients can
damage the kidneys. Excessive increased aldosterone levels and MR
over-activation are known to trigger detrimental processes (e.g. inflammation
and fibrosis) in heart and kidneys in these patients. Kidney performance (the
so-called glomerular filtration rate or GFR) is reduced, and in addition the
damaged kidney loses increased amounts of protein in the urine (albuminuria).
Over time, the kidneys may fail completely. Without either regular dialysis or
a kidney transplant, kidney failure is always fatal. Diabetic kidney disease is
the most common cause of kidney failure world-wide.
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.
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