Bayer's finerenone scores in Phase III FIDELIO-DKD study

German pharma major Bayer (BAYN: DE) today announced positive results from the much anticipated Phase III FIDELIO-DKD study, which is evaluating the efficacy and safety of finerenone versus placebo when added to standard of care for chronic kidney disease (CKD) in patients with type 2 diabetes (T2D), has met its primary endpoint.

The results show that the investigational drug finerenone delayed the progression of CKD by reducing the combined risk of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) greater than or equal to 40% from baseline over a period of at least four weeks, or renal death. Finerenone also reduced the risk of the key secondary endpoint, a composite of time to first occurrence of cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke, or heart failure hospitalization. The clinical data from FIDELIO-DKD will be presented at an upcoming scientific meeting.

Finerenone may only reach the market in 2021, said analysts when Bayer first started trials on the candidate, leaving its prospects uncertain, although Berenberg and Deutsche Bank suggested potential sales of $1.8 billion and $2.0 billion, respectively.