Bayer Linked With New Heart Drug & Kidney Disease


  • Based on encouraging results in two mid-stage studies, ARTS-DN and ARTS-HF, Bayer (OTCPK:BAYRY) plans to initiate three Phase 3 trials assessing finerenone for the treatment of heart failure and diabetic kidney disease. The company expects finerenone to boost its prospects in the cardiovascular treatment space.
  • The planned FINESSE-HF study, will investigate finerenone compared to eplerenone [Pfizer’s (NYSE:PFE) INSPRA] in 3,600 heart failure patients with reduced ejection fraction and type 2 diabetes and/or chronic kidney disease across more than 35 countries in Europe and Asia as well as the U.S.
  • Two other Phase 3s will assess finerenone in diabetic kidney disease (DKD). FIGARO-DKD will enroll 6,400 DKD patients with elevated albumin (>=30 mg/g and <30 mg/g) in their urine (albuminuria) while FIDELIO-DKD will enroll 4,800 DKD patients will very high albuminuria (>=300 mg/g).
  • Finerenone (BAY 94-8862) is a selective oral non-steroidal mineralocorticoid receptor (MR) antagonist that blocks the unwanted effects of MR over-activation by the steroid hormone aldosterone. Increased MR activation can damage the heart and kidneys. Currently available steroidal MR antagonists are frequently underutilized because their use can lead to hyperkalemia (elevated potassium in the blood), renal problems and other deleterious side effects.

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