Bayer HealthCare is expanding the clinical development programme for its investigational drug finerenone with the launch of three phase III clinical trials.
The studies will assess the safety and efficacy of the novel oral nonsteroidal mineralocorticoid receptor antagonist in patients with chronic heart failure, and individuals with diabetic kidney disease.
“Bayer HealthCare is to launch three phase III studies assessing finerenone as a treatment for chronic heart failure and diabetic kidney disease.“
Patients enrolment is expected to begin by the end of the year. The FINESSE-HF study will investigate finerenone compared to eplerenone in more than 3,600 chronic heart failure patients with reduced ejection fraction and type 2 diabetes and/or chronic kidney disease.
The second, FIGARO-DKD, will assess the drug versus placebo in 6,400 patients with the clinical diagnosis of diabetic kidney disease, mainly comprising of patients with high albuminuria.
Finally, FIDELIO-DKD will investigate finerenone in comparison to placebo in 4,800 patients with diabetic kidney disease who mostly have very high albuminuria levels.
Dr Joerg Moeller, member of Bayer HealthCare’s executive committee and head of global development, said: “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.”
4 September 2015
Pharmaceutical Company Product News