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Berlin, June 22, 2023 – Bayer announced today the initiation of FINE-ONE, a global, multicenter, randomized, placebo-controlled, double blind parallel-group Phase III study to evaluate the efficacy and safety of finerenone versus placebo in adults with chronic kidney disease (CKD) and type 1 diabetes (T1D). The primary objective of the study is to demonstrate superiority of finerenone over placebo in reducing urine albumin to creatinine ratio (UACR) over 6 months.
Finerenone is marketed as KerendiaTM or, in some countries, as FirialtaTM, and approved for the treatment of chronic kidney disease associated with type 2 diabetes (T2D) in more than 70 countries worldwide. In contrast to T2D, which is primarily a chronic metabolic disease, in type 1 diabetes the insulin secreting cells of the pancreas are destroyed, which is deemed to be attributable to factors such as genetics and environmental triggers. While T1D usually appears during childhood or adolescence, it can also develop in adults. CKD affects up to 40% of people with T1D. The prevalence of CKD due to T1D increased by 58.2% from 1990 to 2007 and by 21.7% from 2007 to 2017.
“Apart from diabetes and hypertension management, there are currently very limited treatment options to slow kidney disease progression in people with chronic kidney disease and type 1 diabetes,” said Janet McGill, Professor of Medicine in the Division of Endocrinology, Metabolism and Lipid Research at Washington University, and Co-chair of the study’s Executive Committee. “Despite progress in risk reduction in type 2 diabetes, chronic kidney disease in type 1 diabetes remains understudied, leaving a huge unmet need to reduce the risks of end-stage kidney disease and cardiovascular events. New strategies are needed to slow the rate of decline in kidney function, which is why this important study comes as welcome news for people with chronic kidney disease and type 1 diabetes and the clinical community alike.”
The clinical course of CKD in people with T1D is characterized by an increased urinary albumin excretion rate, which is a first sign of kidney damage and may progress to macroalbuminuria and decrease in eGFR in later stages. Despite guideline-recommended therapies to control hyperglycemia, hypertension, and albuminuria in people with type 1 diabetes, residual risk remains high with up to a quarter progressing to end-stage-kidney-disease and CKD being a leading cause of mortality in T1D.
“Despite the toll that long-term kidney complications take on people with T1D, the research conducted to address the high residual risk of kidney disease progression in those living with T1D and chronic kidney disease is extremely scarce,” said Sanjoy Dutta, PhD, Chief Scientific Officer of JDRF, the leading global type 1 diabetes research and advocacy organization. “JDRF is thrilled that Bayer is pursuing a pivotal clinical trial evaluating finerenone’s ability to improve kidney outcomes in people with CKD associated with T1D with the goal of submission to regulatory agencies for consideration. JDRF is committed to collaborating with Bayer to help this critical trial succeed.”
“For almost thirty years, there has been no innovative treatment approved to address the high risk of kidney disease progression in adults with chronic kidney disease and type 1 diabetes. We are excited about the prospect to be able to help these individuals,” said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. “Given the shared underlying cause of chronic kidney disease in both types of diabetes, the strong association of albuminuria with kidney disease progression and the robust body of evidence of efficacy of finerenone in individuals with CKD and type 2 diabetes, we expect that finerenone will also reduce CKD progression in adults with T1D.”
The planned study will investigate finerenone compared to placebo in addition to standard of care in approximately 220 adults with CKD and T1D. Individuals will be randomized in a 1:1 ratio to receive either finerenone or placebo in addition to standard of care, consisting of a renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme inhibitor (ACE) or an angiotensin II receptor blocker (ARB). The efficacy of finerenone in delaying kidney disease progression in the FINE-ONE study will be demonstrated based on a reduction of albuminuria, with the primary endpoint being a change in urine albumin-to-creatinine ratio (UACR) from baseline (ratio to baseline) over 6 months compared to placebo. UACR is planned to be used as a marker to demonstrate the delay of kidney disease progression. In the prespecified FIDELITY pooled analysis of the pivotal Phase III FIDELIO-DKD and FIGARO-DKD studies in people with chronic kidney disease associated with type 2 diabetes, finerenone reduced the risk of chronic kidney disease progression as well as fatal and nonfatal CV events, and also showed a consistent and sustained reduction in UACR by more than 30% versus placebo. Secondary endpoints assess the safety of finerenone and include the number of individuals with treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs) and hyperkalemia (adverse event of special interest).
Mineralocorticoid receptor (MR) overactivation contributes to CKD progression and CV damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors. Finerenone offers protection as it selectively binds to the MR receptor, blocking harmful effects of MR overactivation.
About Kerendia™ / Firialta™ (finerenone)
Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.
In chronic kidney disease associated with type 2 diabetes, based on the positive results of the FIDELIO-DKD Phase III study, Kerendia™ was granted marketing authorization by the U.S. Food and Drug Administration (FDA), the European Commission, and the Chinese National Medical Products Administration (NMPA). In the summer of 2022, Bayer received approval from the U.S. FDA for a label update for Kerendia™ to include findings from the Phase III FIGARO-DKD cardiovascular outcomes study. Based on the Phase III FIGARO-DKD findings, Kerendia™ received approval from the European Commission and the Chinese NMPA for a label extension, to include early stages of CKD associated with T2D. Kerendia™ is also approved in Japan and multiple other countries worldwide.
The Phase III study program with finerenone, FINEOVATE, currently comprises six Phase III studies, FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF, FIND-CKD, FIONA, and FINE-ONE, as well as the Phase II study CONFIDENCE.
FIDELIO-DKD and FIGARO-DKD, the two completed and published Phase III studies with finerenone in CKD and T2D, randomized more than 13,000 people with CKD and T2D worldwide and evaluated the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes.
About Chronic Kidney Disease in Type 1 Diabetes
T1D is a chronic autoimmune disorder characterized by destruction of pancreatic beta cells leading to insulin deficiency and requiring lifelong insulin treatment. Among the US population overall, crude estimates for 2018 indicated that 1.4 million adults aged 20 years or older (or 5.2% of all US adults with diagnosed diabetes), reported both having T1D and using insulin.
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 is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease.
CKD affects up to 40% of people with T1D and 25% of those progress to end-stage renal disease (ESRD). In a systematic analysis for the Global Burden of Disease study, it was reported that the prevalence of CKD due to T1D had increased by 58.2% from 1990 to 2007 and by 21.7% from 2007 to 2017. The 2017 global prevalence of CKD due to T1D was an estimated 32.5 per 100,000 individuals.
The clinical course of CKD in people with T1D is characterized by an increased urinary albumin excretion rate, which is a first sign of kidney damage and may progress to macroalbuminuria and decrease in eGFR in later stages. The treatment of T1D consists of insulin treatment to control hyperglycemia. In people with T1D, blood glucose intervention targeting HbA1c levels ≤7% can slow onset and progression of kidney disease. Despite guideline-recommended treatment with ACEIs and ARBs, residual risk remains high in people with CKD and T1D, with up to a quarter progressing to end-stage-kidney-disease and CKD being a leading cause of mortality in T1D.
About JDRF
JDRF is the leading global T1D research and advocacy organization and is committed to advancing research that can improve the lives of people living with T1D and its complications. JDRF supports Bayer’s efforts to advance finerenone for kidney disease in T1D.
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 the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating 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 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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