Five years after kicking off a massive phase 3 program, Bayer has good news for its heart failure pill finerenone. The drug beat placebo at staving off progression of kidney disease and lowered the risk of heart attacks and strokes in patients with chronic kidney disease (CKD) and Type 2 diabetes.
The study, known as FIDELIO-DKD, is part of a program pitting finerenone against placebo in 13,000 patients with varying severities of kidney disease from early to advanced. Patients received a 10-mg or 20-mg dose of finerenone or placebo on top of the standard of care for CKD. Treatments can include ACE inhibitors and angiotensin II receptor blockers to slow down kidney disease as well as drugs to lower blood sugar levels.
Finerenone beat placebo at staving off kidney failure—when patients need dialysis or a transplant to survive—death from kidney disease or slowing decline in estimated glomerular filtration rate, namely the rate at which the kidneys could filter blood.
It also hit a key secondary endpoint, prolonging time to death from heart disease, or time to nonfatal cardiovascular events such as stroke, heart attack or hospitalization because of heart failure. Bayer will present full data at an upcoming medical meeting. A second phase 3 study, FIGARO-DKD, is slated to read out next year.
Bayer is also testing the drug in a 5,500-patient study to see whether it can beat placebo at keeping patients alive and reducing hospitalizations or urgent visits for heart failure.
Finerenone is a next-generation mineralocorticoid receptor antagonist, or MRA, designed to block the production of steroids in the body that degrade heart function and lead to kidney problems. Older MRAs are already used to control high blood pressure and tamp down on inflammation and scarring that come with diabetic kidney disease, but their use is limited.
“Safety concerns mean that existing MRAs are only used as a last resort—Pfizer’s Inspra or the older spironolactone are examples—and Bayer is hoping to show that finerenone is an entirely different proposition,” Evaluate wrote earlier this year. Bayer believes its non-steroidal nature and better selectivity should lead to fewer side effects, including very high potassium levels.
Evaluate called the phase 3 program a “bold bet” but one with a potentially dwindling likelihood of paying off. Though cross-trial comparisons are always tricky, the finerenone data will be held up against the record of Invokana, Johnson & Johnson’s SGLT2 inhibitor.
The FDA slapped the diabetes med with a black box warning for amputation risks in 2017 but went ahead and OK’d it for diabetic kidney disease last September, making it the first drug of its class for this indication. In a pivotal trial, Invokana reduced the risk of end-stage kidney disease by 32% and tamped down on cardiovascular events by 20% to 30%. Evaluate expects SGLT2 drugs from AstraZeneca and Eli Lilly to turn up similar results.