The leading German drug maker, Bayer, is ready to fulfil its ambition in cardiovascular medicine as the company has decided to move its new heart failure drug into the final testing stages. The decision came after the mid-stage testing, during which the drug proved to perform even better than its older rival.
In the announcement, the Bayer HealthCare said that it is ready to conduct the expansion of the clinical development program for its oral, non-steroidal mineralocorticoid receptor antagonist finerenone, or BAY 94-8862 with Phase III studies.
The final stage trial involves the study of the effect of the drug, its efficiency and safety in patients with diabetic kidney disease and chronic heart failure. The first batch of patients is expected to be recruited by the end of 2015. The company is planning to enrol around 3,600 patients for the Phase III trial.
The company's decision was based on the positive data and outcome of the mid-stage trial, during which the researchers conducted four dose-finding studies in patients with kidney disease due to diabetes or a chronic heart failure.
"We are excited about finerenone being the first mineralocorticoid receptor antagonist that is being developed in parallel in chronic heart failure and diabetic kidney disease,” said the head of Global Development at Bayer, Joerg Moeller, in a statement. “The studies will investigate whether finerenone can reduce cardiovascular morbidity and mortality as well as the progression of renal disease in these patients with a well-tolerated safety profile."
A forecast conducted by Berenberg and Deutsche Bank suggests that the drug will have potential sales of about $2.0 billion. The drug is expected to hit the market shelves only by 2020 or 2021.