Boehringer Ingelheim and Lilly announce an academic collaboration with University of Oxford

Boehringer IngelheimBoehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) have announced an academic collaboration with the University of Oxford. EMPA-KIDNEY will investigate the effects of empagliflozin on the progression of kidney disease and the occurrence of cardiovascular death, in people with established chronic kidney disease with and without diabetes. The study will be independently conducted, analysed and reported by the Medical Research Council Population Health Research Unit at the University of Oxford (MRC PHRU), which is based in the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU). Boehringer Ingelheim and Eli Lilly and Company will provide the funding for the study.

The plan to conduct a dedicated outcomes study in people with chronic kidney disease is based on insights previously obtained from the EMPA-REG OUTCOME® trial. This landmark trial investigated the effect of empagliflozin, when added to the standard of care, on cardiovascular outcomes in people with type 2 diabetes and established cardiovascular disease, compared with placebo.(1) Approximately one third of patients in the EMPA-REG OUTCOME® trial also had established chronic kidney disease at baseline. A secondary exploratory endpoint of the study provided promising data relating to the reduction in the relative risk of new onset or worsening kidney disease. EMPA-KIDNEY will help to further understand this data.(1,2)

"The data from the EMPA-REG OUTCOME® trial indicate that empagliflozin may have the potential to slow progression of kidney disease and to lower cardiovascular risk among people with chronic kidney disease," said Professor Colin Baigent, Director of the MRC PHRU at the University of Oxford, UK. "Chronic kidney disease is estimated to affect more than 200 million individuals worldwide and many of these patients are at substantial risk of progressing to end-stage kidney disease. In addition, people with chronic kidney disease are at increased risk of premature death from cardiovascular causes. In light of the high medical need in this area, we are excited to be leading the EMPA-KIDNEY study to find out whether empagliflozin could become a new treatment option to improve the lives of people with chronic kidney disease."

EMPA-KIDNEY will include approximately 5,000 people with established chronic kidney disease, with and without diabetes. The primary outcome of the study is to assess the effect of empagliflozin on time to clinically relevant kidney disease progression or cardiovascular death. The study will be part of the empagliflozin clinical development programme, the largest clinical development programme of an SGLT2 inhibitor.

"We are delighted to partner with such a prestigious academic institution as Oxford University. The scientists at Oxford University have a proven track record in conducting innovative and paradigm changing clinical trials in patients with chronic kidney disease," commented Dr Georg van Husen, Senior Vice President, Therapeutic Area CardioMetabolism, Boehringer Ingelheim. "We share a common interest and commitment to better understand and improve the treatment of chronic kidney disease, and are excited to further explore the potential of empagliflozin in new disease areas."

"The EMPA-KIDNEY study, which will build on results of the EMPA-REG OUTCOME® trial, will continue to expand our understanding of how empagliflozin can impact the lives of a broad range of people with and without diabetes," added Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly Diabetes. "We look forward to this new partnership, and the opportunity to follow the progress of the EMPA-KIDNEY study."

About the MRC PHRU at the University of Oxford

The focus of MRC PHRU at the University of Oxford is to improve treatment and prevention of chronic diseases, particularly cardiovascular disease and metabolic disease (e.g. diabetes mellitus and chronic kidney disease), which collectively account for a large proportion of premature adult deaths and the burden of disability worldwide. MRC PHRU leads innovative clinical trials and meta-analyses to identify important advances that could have a major impact on health. Its worldwide approach, involving the study of large numbers of people, provides reliable information about the causes of disease and the effects of treatments, which can have a major impact on global health.

About EMPA-KIDNEY: The study of heart and kidney protection with empagliflozin

EMPA-KIDNEY is a multinational randomised, double-blind, placebo-controlled clinical trial. It is designed to evaluate the effect of empagliflozin on clinically relevant outcomes: kidney disease progression and cardiovascular mortality risk. The primary outcome is defined as time to a first event of either a cardiovascular death or kidney disease progression, defined as end stage kidney disease (the need for kidney replacement therapy such as, dialysis or kidney transplantation)3, a sustained decline in eGFR to <10mL/min/1.73m2, renal death or a sustained decline of ≥40% in eGFR from randomisation. EMPA-KIDNEY will include people with established chronic kidney disease both with and without diabetes receiving current standard of care.

The study will be conducted in selected countries representing a global footprint and aims to randomise approximately 5,000 participants to receive either empagliflozin 10 mg once daily or placebo, on top of standard of care.

About Chronic Kidney Disease

Chronic kidney disease is defined as a progressive decline of kidney function over time.

About two thirds of chronic kidney disease cases are attributable to metabolic conditions such as diabetes, obesity and hypertension.(4,5,6)
Notably, chronic kidney disease is associated with increased morbidity and mortality. The majority of deaths among people with chronic kidney disease occur as a result of cardiovascular complications, often before reaching end stage kidney disease.(7,8,9) Once end stage kidney disease is reached, affected individuals have to undergo kidney replacement treatments, such as chronic dialysis or kidney transplantation.3 Chronic kidney disease is highly prevalent in various parts of the world, affecting more than 10 percent of the population.(10) Since there is currently no approved treatment available to specifically reduce kidney disease progression and cardiovascular death, the overarching unmet medical need for new treatment options in people with chronic kidney disease is evident.

About EMPA-REG OUTCOME®

EMPA-REG OUTCOME® is a long-term, multinational, randomised, double-blind, placebo-controlled clinical trial of more than 7,000 people from 42 countries with type 2 diabetes and established cardiovascular disease.

The study assessed the effect of empagliflozin (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and cardiovascular drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal heart attack or non-fatal stroke.

Although the EMPA-REG OUTCOME® trial was not designed to assess the potential mechanisms behind the effect of empagliflozin on kidney outcomes, the kidney assessment was part of a pre-specified exploratory analysis plan of secondary endpoints.

The overall safety profile of empagliflozin in the EMPA-REG OUTCOME® trial was consistent with that of previous trials.

About Empagliflozin

Empagliflozin (marketed as Jardiance®) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death reduction data in the label in several countries.(11,12,13)

Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes and high blood sugar levels leads to excretion of excess sugar in the urine. In addition, initiation of empagliflozin increases excretion of salt from the body and reduces the fluid load of the body’s blood vessel system (i.e. intravascular volume). Empagliflozin induces changes to the sugar, salt and water metabolism in the body that may contribute to the reductions in cardiovascular death observed in the EMPA-REG OUTCOME® trial.

Empagliflozin is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

About Boehringer Ingelheim and Eli Lilly and Company

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centres on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world’s leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of people with diabetes and stand together to focus on patient needs. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributed to the alliance.

About Boehringer Ingelheim

Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales. Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does.

About Lilly Diabetes

Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a wide range of therapies and a continued determination to provide real solutions - from medicines to support programs and more - we strive to make life better for all those affected by diabetes around the world.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

1. Zinman B., et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 10.156 (2015).
2. Wanner C, et al. Empagliflozin and progression of kidney disease in type 2 diabetes. N Engl J Med. 2016;375:323-334.
3. American Kidney Fund. Kidney Failure (ESRD) Causes, Symptos, & Treatments. Available at: http://www.kidneyfund.org/kidney-disease/kidney-failure/. Accessed March 2018.
4. Levin A, Tonelli M, Bonventre J, et al. Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy. Lancet 2017;390:1888-917.
5. United States Renal Data System, USRDS 2012 Annual data report: Atlas of chronic kidney disease and end-stage renal disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2012. Available from: http://www.usrds.org/reference.htm. See Appendix I, United States Renal Data System (USRDS).
6. Liyanage T, Ninomiya T, Jha V, et al. Worldwide access to treatment for end-stage kidney disease: a systematic review. Lancet 2015; 385(9981):1975-82.
7. Sarnak MJ, Levey AS, Schoolwerth AC, et al. Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Hypertension 2003;42:1050-65.
8. Tonelli M, Wiebe N, Culleton B, et al. Chronic kidney disease and mortality risk: a systematic review. J Am Soc Nephrol. 2006;17:2034-47.
9. Schiffrin EL, Lipman ML and Mann JFE. Chronic kidney disease: effects on the cardiovascular system. Circulation. 2007;116:85-97.
10. Eckardt K-U, Coresh J, Devuyst O, et al. Evolving importance of kidney disease: from subspecialty to global health burden. Lancet 2013;382:158-69.
11. Jardiance® (empagliflozin) tablets U.S. Prescribing Information. Available at: http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf. Accessed March 2018.
12. European Summary of Product Characteristics Jardiance®, approved January 19, 2017. Data on file.
13. Jardiance® (Full Prescribing Information). Mexico; Boehringer Ingelheim Pharmaceuticals, Inc; 2017.

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