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Finerenone Cuts Deaths in Mid-Stage Trial

Heart failure drug to move into phase III testing this year

Promising data from an exploratory phase IIb trial of finerenone (Bayer Healthcare), an oral, nonsteroidal mineralocorticoid receptor antagonist (MRA), have been presented at the European Society of Cardiology (ESC) Congress 2015 in London. The ARTS-HF study investigated the effects of different dosages of finerenone compared with eplerenone in patients with worsening chronic heart failure (CHF) with a reduced ejection fraction as well as type-2 diabetes mellitus and/or chronic kidney disease.

Finerenone showed a reduction in prohormone brain natriuretic peptide (NT-proBNP), a surrogate marker, that was comparable with that of eplerenone when 90-day results were compared with baseline. Finerenone also demonstrated meaningful reductions in the key exploratory endpoints of all-cause death and cardiovascular hospitalization compared with eplerenone, with the lowest incidence observed in the finerenone 10/20-mg dose group. The ARTS-HF trial involved a total of 1,055 patients in 25 countries.

Bayer has decided to expand the clinical development program for finerenone with three phase III studies. These trials will investigate the efficacy and safety of finerenone in patients with CHF and in patients with diabetic kidney disease (DKD), with the first participants expected to be enrolled by the end of the year.

The initiation of the phase III FINESSE-HF study in CHF patients is based on the promising data from the ARTS-HF trial. The new study will compare finerenone with eplerenone in more than 3,600 CHF patients with a reduced ejection fraction and type-2 diabetes mellitus and/or chronic kidney disease in more than 35 countries, including the U.S., Europe, Japan, and China.

The phase III program in DKD patients comprises two additional studies. FIGARO-DKD will investigate finerenone versus placebo in 6,400 patients with a clinical diagnosis of DKD (mainly patients with high albuminuria), and FIDELIO-DKD will investigate finerenone in comparison with placebo in 4,800 patients with a clinical diagnosis of DKD (mainly patients with very high albuminuria). The participants will receive finerenone or placebo on top of current standard of care, which will include renin–angiotensin system (RAS)-blocking therapy, such as angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs). Both studies will be conducted in approximately 40 countries, including the U.S., Europe, Japan, and China.

Finerenone is a selective oral nonsteroidal MRA that blocks the 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 with heart failure and a reduced ejection fraction. However, they are often underutilized because of the incidence of hyperkalemia, renal dysfunction, and antiandrogenic/progestogenic adverse events. Finerenone, a third-generation MRA, has demonstrated promising efficacy and safety profiles in preclinical studies as well as in phase I and phase II clinical studies.

Despite recent advances, CHF remains a deadly disease, with a 5-year survival rate similar to that of patients with advanced cancer. DKD is a common complication of diabetes and is the most frequent cause of end-stage renal disease (ESRD) in Western countries. Diabetes causes more than 40% of new cases of ESRD.

Source: Bayer Healthcare; August 31, 2015.

 

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