Bayer’s Kerendia demonstrates success in phase 3 clinical trials for treatment of heart failure

1. A phase 3 trial showed Kerendia reduced the risk of cardiovascular death by 16% compared to placebo.
2. Hyperkalemia was greater in patients treated with Kerendia but not by a significant margin.

The Latest

Bayer has revealed the results of its phase 3 FINEARTS-HF trial for its nonsteroidal mineralocorticoid receptor antagonist Kerendia. Originally approved for use in patients with chronic kidney disease (CKD) associated with Type 2 diabetes (T2D), Bayer has been determined to expand its market to treat patients with heart failure (HF). The results of the trial showed that compared to placebo, in HF patients with an ejection fraction greater than 40%, Kerendia reduced the risk of cardiovascular death and first and recurrent HF events by 16%. Kerendia demonstrated good overall safety. The trial showed that adverse events related to high blood potassium levels were higher in the Kerendia group vs the placebo group (9.7 vs 4.2%). These events resulted in no hospitalizations or deaths, and did not require the patient to stop taking the drug.

Physician’s Perspective

Heart failure currently affects more than 64 million people worldwide. This number is expected to rise. Congestive HF occurs when the heart’s ability to pump blood becomes impaired causing blood to back up and leak through blood vessels. This results in the build-up of fluid in the ankles, arms and other organs like the lungs leading to symptoms like shortness of breath. Heart failure has a complex pathophysiology involving many mechanisms, and as a result its management involves several classes of medications. Mineralocorticoid receptor antagonists (MRAs) are a class of drugs that address one of the mechanisms involved in heart failure. This drug however can lead to hyperkalemia (high blood potassium levels) which can negatively impact one’s heart rhythm. Conventional MRAs like spironolactone have previously not been shown to reduce hospitalization from HF. Kerendia is unique as it is the first MRA to show evidence of a significantly lower rate of total worsening HF events, and death from cardiovascular causes.

Molecular Target of Therapy

In heart failure, due to impaired cardiac output blood pressure drops. The body compensates by activating a special system to increase the blood pressure. One component of this mechanism involves the activation of MRs which promote salt and water retention. This effort to increase the blood pressure leads to further fluid build up however, as the core problem of heart failure is not addressed. Kerendia is a nonsteroidal MRA that selectively and potently binds to MRs which prevents fluid build up from occurring. By working against aldosterone, it is also thought to reduce scarring of the heart.

Company History

Bayer is a multinational pharmaceutical and biotechnology company. In addition to pharmaceuticals and consumer health products, Bayer’s other interests include agricultural chemicals, and biotechnology products. Bayer’s best-selling and most known products include Aspirin and Xarelto for blood clots, Mirena for birth control and Adalat for hypertension. Bayer’s drug development pipeline is vast and includes over 31 products in various phases of clinical trials ranging from cardiovascular products to oncology therapies. One of these therapies is Darolutamide which is in a phase 3 clinical trial used to treat prostate cancer.

Additional Reading: https://www.nejm.org/doi/full/10.1056/NEJMoa2407107