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Bayer to forge ahead with Finerenone trials on positive data

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(Bloomberg) — Bayer AG will conduct final-stage tests on an experimental drug to treat chronic heart failure and diabetic kidney disease following successful mid-stage trials.

The latest studies determined the right dosing levels for the medicine, called finerenone, Leverkusen, Germany-based Bayer said in a statement on Monday. The company will now examine the drug’s efficacy and safety in almost 15,000 patients it hopes to enlist over three years.

Study results so far “make us very confident to move finerenone forward into Phase III across two important indications of high unmet medical need,” Joerg Moeller, head of global development at Bayer HealthCare, said in the statement.

Finerenone is the next generation of treatments to block the damaging effects caused by the hormone aldosterone in patients with chronic heart failure, which one in five people are likely to develop in their lifetime. The final-stage study, called FINESSE-HF, will compare finerenone to eplerenone, a generic medicine in the same class.

The market potential for drugs like finerenone could be several billion dollars a year, but that would probably be shared with potential competitors from Novartis AG (NYSE:NVS) and other drugmakers, according to Odile Rundquist, an analyst at Baader-Helvea in Geneva.

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The existing care is “not being used enough” because of safety concerns, Frank Misselwitz, head of cardiovascular and coagulation therapeutics at Bayer, said in an interview. He is overseeing the studies.

Clinical trials for diabetic kidney disease, a common complication of diabetes, will compare finerenone to a placebo. The studies, dubbed FIGARO-DKD and FIDELIO-DKD, will investigate cardiovascular impacts as well as the progression of kidney disease. The trials are “event driven,” which means they’ll end when the company has enough data on finerenone’s effects.

Almost 390 million people have diabetes and a third may develop diabetic kidney disease, according to the International Diabetes Federation.

Bayer, which is researching new treatments for a variety of heart, lung, blood and kidney diseases, is presenting the results of its finerenone Phase IIb trial on Monday at the European Society of Cardiology conference in London.