Bayer Moves to Phase III Studies After Finerenone Cuts Deaths in Mid-Stage Trial
August 31, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Bayer HealthCare , a subgroup of Bayer AG , announced today that it is moving its clinical development of finerenone into Phase III clinical trials.
Finerenone is an oral, non-steroidal mineralocorticoid receptor antagonist (MRA) used to treat patients with chronic heart failure (CHF) and patients with diabetic kidney disease (DKD). There are several MRAs on the market, such as Inspra, manufactured by Pfizer Inc. , but this class of drugs often cause abnormally high levels of potassium in the blood. This can cause irregular heart beat and even cardiac arrest. The MRAs spironolactone and eplerenone, are also linked to kidney problems.
Bayer’s finerenone has a different mechanism and appears to avoid the high potassium and kidney problems. “If you can eliminate hyperkalemia (high potassium), that would be a huge benefit to patients,” said Mary Norine Walsh, vice president of the American College of Cardiology (ACC), to Reuters. Walsh was not involved in the Bayer research.
“The data we have seen for finerenone to date across the clinical development program make us very confident to move finerenone forward into Phase III across two important indications of high unmet medical need,” said Joerg Moeller, member of the Bayer HealthCare Executive Committee and head of global development. “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. 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.”
Bayer plans to enroll approximately 3,600 patients in the Phase III trial, which is expected to begin recruiting by the end of the year.
Analysts with Berenberg and Deutsche Bank project the drug, if approved, could bring in $2 billion in sales. Other drug companies are working in the same area, however, including Novartis AG .
The current announcement was based on results of data from the Phase IIb ARTS-DN study, which was presented at the World Congress of Nephrology (WCN) in March. The study had 823 patients with Type 2 diabetes and a clinical diagnosis of diabetic kidney disease. Using finerenone showed a significant drop in albuminuria without negatively affecting serum potassium or kidney function compared to placebo on top of RAS-blocking therapy. There were few adverse events and serious adverse events in comparison to standard therapy.
The Phase III program will be made up of two studies. FIGARO-DKD will study finerenone against placebo in 6,400 patients with a diagnosis of diabetic kidney disease, mainly patients with high albuminuria. The second study, FIDELIO-DKD, will study finerenone against placebo in 4,800 patients with a clinical diagnosis of diabetic kidney disease in patients with very high albuminuria. The studies are expected to take place in approximately 40 countries, including the U.S., Europe, Japan and China. Patients who receive either finerenone or a placebo will also receive standard of care, which includes RAS-blocking therapies like ACE inhibitors or ARBs.