Bayer Moves To Final Testing Of Heart Drug After Success

Bayer heart failure drug will enter into final-stage testing later this year after the drug dramatically cut the number of deaths in its mid-stage trial.

The German group has done well with lately launched drugs, including stroke prevention pill Xarelto and eye treatment Eylea, and thus it is not keen to show that it has another potential billion-dollar-plus victor in finerenone.

Finerenone is an enhanced version of a troublesome class of heart drugs known as mineralocorticoid receptor antagonists (MRAs). Other MRAs that are now available in the market such as eplerenone and spironolactone (Inspra) manufactured by Pfizer are said to be incompatible with majority of patients because these can lead to significant elevation of blood potassium levels, which may subsequently result in irregular heart beat and ultimately, cardiac arrest.

Meanwhile, it also plans to conduct two trials in patients with diabetic kidney disease (DKD), namely FIGARO-DKD and FIDELIO-DKD, that build on an earlier phase II trial which showed that adding finerenone to drugs such as ACE inhibitors or angiotensin II receptor antagonists seemed to reduce renal damage.

Bayer’s pill, however, works in a different way and appears to avoid these issues, so cardiologists are watching its development closely. She was however not associated with the study.

Finerenone presents itself as the next generation of treatments to stop the damaging effects that result from the hormone aldosterone in patients suffering from chronic heart failure.The last phase of the study, called FINESSE-HF, will compare finerenone to eplerenone, a generic medicine in the same category.

Although, finerenone could possibly take years to reach the market.

The current care is “not being used enough” because it is being feared unsafe, head of cardiovascular and coagulation therapeutics at Bayer, Frank Misselwitz affirmed in an interview.

Larger tests would now be needed to confirm these benefits. Bayer’s researchers are particulary excited about the upcoming trial, because this is the first MRA that is being developed in parallel for treatment of chronic heart failure and diabetic kidney disease. More than 3,600 patients with heart failure, diabetes and/or kidney disease will be enrolled in the phase III study.