Bayer extends clinical development program for finerenone with Phase III study in patients with non-diabetic chronic kidney disease

There are limited treatment options available for chronic renal disorder (CKD), and patients often still reach renal failure or premature death / The phase III clinical trial study FIND-CKD will investigate the effect of finerenone on kidney and cardiovascular outcomes in patients with non-diabetic chronic renal disorder
Bayer announced today the initiation of the FIND-CKD study, a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial study to research the efficacy and safety of finerenone additionally to guideline-directed therapy, on the progression of chronic renal disorder (CKD) in patients with non-diabetic CKD. the first objective of the study is to demonstrate superiority of finerenone over placebo in delaying the progression of renal disorder in these patients. the first outcome measure is that the mean rate of change in kidney function over time (estimated glomerular filtration rate, eGFR slope) from baseline to month 32.

“In 2017, an alarming 1.2 million people died from chronic renal disorder worldwide. Although diabetes is well-recognized as a number one explanation for chronic renal disorder globally, a considerable proportion of the worldwide burden is non-diabetic in origin and due to other causes, like hypertension. to enhance outcomes, new treatments which will target kidney-specific disease mechanisms are highly desired,” said Hiddo L. Heerspink, Professor of Clinical Trials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee. “If successful, this study might be of great significance to those living with chronic renal disorder globally.”

Finerenone is an investigational, non-steroidal, selective mineralocorticoid (MR) antagonist that has been shown in preclinical studies to dam harmful effects of MR overactivation. MR overactivation is assumed to contribute to CKD progression and cardiovascular damage which may be driven by metabolic, hemodynamic or inflammatory and fibrotic factors. Finerenone has already demonstrated benefits on kidney and cardiovascular outcomes in patients with chronic renal disorder and sort 2 diabetes in two completed phase III clinical trial studies, FIDELIO-DKD and FIGARO-DKD.

“Finerenone has been studied thus far in additional than 13,000 patients through the great clinical test |phase III|clinical trial|clinical test”> phase III clinical trial clinical trial program in chronic renal disorder and sort 2 diabetes, which demonstrated positive kidney and cardiovascular outcomes for finerenone versus placebo on top of ordinary of care,” said Dr. Christian Rommel, Member of the chief Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “The new FIND-CKD study extends our clinical research for finerenone to a non-diabetic population where the unmet need is high for brand spanking new treatments to delay disease progression.”

The planned phase III clinical trial FIND-CKD study will investigate finerenone compared to placebo additionally to plain of care in additional than 1,500 patients with non-diabetic chronic renal disorder etiologies, including hypertension and chronic glomerulonephritis (inflammation of the kidneys). Patients are going to be randomized to receive either finerenone 10mg or 20mg or placebo on top of individually tolerated maximum labeled doses of a renin-angiotensin system (RAS)-blocking therapy like an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB).

In July, finerenone was approved under the name Kerendia® by the us (U.S.) Food and Drug Administration (FDA) supported the positive results of the FIDELIO-DKD phase III clinical trial study for patients with CKD and T2D. Finerenone has also been submitted for marketing authorization within the European Union (EU) and China, also as multiple other countries worldwide and these applications are currently under review.

About Chronic Kidney Disease
CKD is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. CKD affects 840 million people worldwide. In the U.S., 1 in 3 adults is at risk for the disease. At advanced stages of CKD, patients may need dialysis or a kidney transplant to stay alive. Healthy kidneys act as the body’s filter, removing waste products from the blood. They also control how much water and electrolytes are in the body, regulating blood pressure. As kidney function goes down, patients may experience a range of symptoms including leg swelling, tiredness in the day, nausea, muscle cramps, joint pain and confusion, trouble focusing, memory problems. Major risk factors of CKD include diabetes and hypertension.

About Bayer’s Commitment in Cardiovascular and Kidney Diseases
Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros.

Source link: