Bayer HealthCare, a subgroup of Bary AG and one of the world’s leading innovative companies in the healthcare and medical products industry, recently announced it will expand their clinical development program of its oral non-steroidal mineralocorticoid receptor antagonist finerenone (BAY 94-8862) with three Phase III clinical trials.
The trials will assess the safety and efficacy of the drug in patients with a diagnosis of chronic heart failure and in patients with a diagnosis of diabetic kidney disease. The company expects to enroll the first patients by the end of 2015.
Each year in the United States, more than 100,000 people are diagnosed with kidney failure, a serious condition in which the kidneys fail to dispose of bodily wastes. Kidney failure is the final stage of chronic kidney disease (CKD) and diabetes is the most common cause of kidney failure, accounting for nearly 44 percent of all new cases. Even when diabetes is controlled, the disease can lead to CKD and kidney failure. Most people with diabetes do not develop CKD that is severe enough to progress to kidney failure. However, nearly 24 million people in the United States have diabetes, and nearly 180,000 people are living with kidney failure as a result of the disease.
“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 Phase III clinical trials’ initiation (known as FIGARO-DKD and FIDELIO-DKD in diabetic kidney disease) is based on the results of the company’s Phase IIb ARTS-DN clinical trial, which was recently presented at the World Congress of Nephrology (WCN).
A total of 823 patients with type 2 diabetes and diabetic nephropathy took part in the ARTS-DN study. All patients received treatment for 90 days. Results from this study showed that adding a once-daily oral finerenone to renin-angiotensin system (RAS)-blocking therapy significantly reduced the change from baseline to 90 days follow-up in urine albumin-to-creatinine ratio (UACR) in comparison to placebo upon treatment with the four highest doses of the drug.
Finerenone treatment groups and standard therapy had a similar incidence of serious adverse events (SAEs) and of treatment-emergent adverse events (TEAEs). Because the study time period was only of 90 days the researchers did not examined the long-term effects of finerenone on cardiovascular or renal function outcomes.
Bayer HealthCare’s Phase III clinical development program in Diabetic Kidney Disease (DKD) involves two clinical trials.
FIGARO-DKD will assess treatment with finerenone versus placebo in a population of 6,400 patients with diabetic kidney disease mostly including patients with high albuminuria (300 mg/g > UACR >/= 30mg/g). FIDELIO-DKD will assess treatment with finerenone compared to placebo in a population of 4,800 patients with diabetic kidney disease, mostly including patients with very high albuminuria (UACR >/= 300mg/g). Both clinical trials will be conducted across nearly 40 countries.
Patients will be treated with finerenone or with a placebo in addition to a standard of care RAS-blocking therapy involving angiotensin receptor blockers (ARBs) or angiotensin-converting enzyme inhibitors (ACEIs).
The initiation of the Phase III FINESSE-HF clinical trial in patients with chronic heart failure is based on the results from a recent pivotal Phase IIb ARTS-HF clinical trial, recently presented in a Hot Line Session during the ESC Congress Congress 2015 in London, United Kingdom.
The study assessed the clinical effects of different doses of finerenone in comparison to eplerenone in patients with worsening chronic heart failure and reduced ejection fraction (HFrEF), chronic kidney disease and/or type 2 diabetes mellitus. Results from the study revealed that finerenone was able to reduce the surrogate marker N-terminal prohormone B-type natriuretic peptide (NT-proBNP), when comapred to eplerenone.
The Phase III clinical trial FINESSE-HF will assess finerenone in comparision to eplerenone in patients with chronic heart failure with reduced ejection fraction and type 2 diabetes mellitus and/or chronic kidney disease. The study will be conducted in about 35 countries and patients enrolled in the study will be treated with eplerenone or finerenone in addition to current standard treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blocker (ARBs) and β-blockers.