At this year’s European Society of Cardiology Congress, positive results were presented from Bayer’s FIGARO-DKD Phase III trial of Kerendia (finerenone), providing insight into the drug’s ability to reduce the risk of morbidity and mortality in diabetic kidney disease patients. Specifically, the trial set out to evaluate whether finerenone is effective and safe in treating patients with mild to moderate kidney disease and type 2 diabetes (T2D). The positive data from the FIGARO-DKD study will help support the use of finerenone to improve cardiorenal outcomes for chronic kidney disease (CKD) and T2D patients.
The FIGARO-DKD study, which enrolled 7,437 patients, showed that cardiovascular benefit was mainly driven by a 29% decrease in hospitalisation for heart failure. In addition, the study found that end-stage kidney disease occurred in 32 patients in the finerenone group compared with 49 patients in the placebo group. Regarding overall safety, the risk of hyperkalaemia (HK) was increased in patients receiving finerenone, at 10.8%, compared to a 5.3% risk in placebo patients. Key opinion leaders interviewed by GlobalData have emphasised that physicians are reluctant to prescribe mineralocorticoid receptor antagonists (MRAs) as HK is a common adverse event.
In addition to this, Bayer previously completed a Phase III study, FIDELIO-DKD. The study showed that finerenone was able to delay the progression of CKD by reducing the combined risk of time to the first incidence of kidney failure, and a sustained decrease of estimated glomerular filtration rate above 40% from baseline over a four-week period. Safety results from the FIDELIO study were similar to those of the FIGARO study, with HK-related adverse events being reported in 18.3% of the finerenone group compared to 9% of the placebo group.
The large numbers of patients in both FIGARO-DKD and FIDELIO-DKD will likely drive a better understanding of finerenone’s effects on kidney disease and T2D. According to GlobalData’s Pharma Intelligence Centre drug database, Bayer has two products in development for diabetic nephropathy, namely finerenone and fulacimstat. Finerenone is an MRA that acts as a diuretic and lowers blood pressure by inhibiting the reabsorption of salts, decreasing blood volume and antagonising the action of aldosterone, which is a component of the renin-angiotensin-aldosterone system. Fulacimstat is a first-in-class chymase inhibitor currently in Phase II development for the global market.