Bayer has announced a further commitment to its clinical development program known as MOONRAKER, which is focused on investigating the potential of Kerendia® (finerenone) as a treatment for heart failure (HF). This commitment involves the initiation of three additional studies through collaboration with investigator-sponsored initiatives. With an estimated recruitment of around 15,000 patients, MOONRAKER is set to become one of the largest study programs for heart failure to date.

These three new studies are being conducted under the sponsorship of CPC Clinical Research, a non-profit academic research organization affiliated with the University of Colorado. These studies are being carried out in collaboration with other academic research organizations, and the funding for these initiatives is provided by Bayer.

In addition to the ongoing Phase III study known as FINEARTS-HF, which examines the impact of finerenone versus placebo in conjunction with standard of care (SoC) for over 6,000 HF patients with mildly reduced or preserved ejection fraction, the new studies will assess the effectiveness and safety of finerenone for approximately 9,000 more HF patients with conditions such as reduced ejection fraction (HfrEF), mildly reduced ejection fraction (HfmrEF), and preserved ejection fraction (HfpEF).

Dr. Michael Devoy, Chief Medical Officer at Bayer, stated that the inclusion of the REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF studies within the MOONRAKER heart failure clinical trial program aims to provide a comprehensive insight into the potential of finerenone as a heart failure treatment. These studies will analyze its effectiveness and safety across a broad spectrum of patients and clinical scenarios, complementing the existing Phase III FINEARTS-HF study. The goal is to gain valuable insights that can guide the potential clinical application of finerenone in treating heart failure.

Robert Perkins, MD, Vice President of Cardiovascular & Renal at Bayer, emphasized the company's determination to advance research and innovations that can offer new treatment options for patients dealing with high unmet medical needs. The additional trials under the MOONRAKER program have been designed to rigorously address common and critical clinical scenarios for individuals living with heart failure. Bayer aims to meet the demand for improved solutions swiftly, and these initiatives are a response to that urgent need.

 

Source: businesswire.com

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