Boehringer Ingelheim and Lilly Announce an Academic Collaboration with University of Oxford to Investigate the Effects of Empagliflozin in People with Chronic Kidney Disease
Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) today 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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180416005697/en/
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 (https://www.mrc-phru.ox.ac.uk/) 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 ®1,2
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.
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).
Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/EMPA-KIDNEY
Dr Petra Kienle
Product Communication Manager
Phone: +49 (6132) 77 143877
Manager, Global Business Communications
Eli Lilly and Company
Phone: +1 (317) 954-9907
Communications at MRC PHRU
Phone: +44 (0) 1865 743960
Mobile: +44 (0) 7979 940972
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Aptorum Group’s Smart Pharma announces launch of its asset backed Smart Pharma token (SMPT), supported by its computational repurposed drug discovery platform Smart-ACT™24.4.2019 11:30:00 EEST | Tiedote
Aptorum Group Limited (Nasdaq:APM) is excited to announce the launch and issuance of its asset backed Smart Pharma Token (“SMPT”) by its wholly owned subsidiary group, Smart Pharma group and Smart Pharmaceutical Limited Partnership (“SPLP”) targeted in May 2019. SPLP is extremely pleased to have jointly developed the SMPT token with Aenco, an affiliated blockchain development company focused on applications in the healthcare and financial sector. The SMPT token, an ERC-1404 security compliant token, is a unique token that tokenizes valuable pharmaceutical drugs and their underlying intellectual property and associated allocation of cash flows induced by continual product development and commercialization. It is the intention of the Smart Pharma group to continue to incorporate Aenco’s blockchain technology into its pharmaceutical development and commercialization processes. Relying on intellectual property derived from the Smart-ACT™ platform, Smart Pharma’s in-house new and repurposed
Aptorum Group Establishes Smart Pharma to Focus on Computational Repurposed Drug Discovery for Orphan and Unmet Diseases24.4.2019 11:30:00 EEST | Tiedote
Aptorum Group Limited (Nasdaq: APM) today announced the establishment of a new subsidiary group, Smart Pharma (“SmartP”), which operates its novel computational repurposed drug discovery, modeling and validation platform, together referred to as the “Smart-ACTTM” platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190424005095/en/ (Photo: Business Wire) Smart-ACTTM stands for Accelerated Commercialization of Therapeutics and encompasses state-of-the-art technology in systematic screening of existing approved drug molecules against selected therapeutic targets. Specifically, the Smart-ACTTM platform comprises of a network of modules and processes that simulate the effectiveness of drug molecules against diseases for outcome prediction and selection. The Smart-ACTTM platform will initially focus on the screening drug molecules for orphan diseases or unmet medical needs. To date, SmartP has, under the recently established
Aptorum Group Limited Announces Repurchase of USD13,500,000 Outstanding Convertible Bonds Due 201924.4.2019 11:15:00 EEST | Tiedote
Aptorum Group Limited (NASDAQ: APM) (“Aptorum” or the “Company”), a pharmaceutical company focused on the development and commercialization of therapeutic and diagnostic technologies to tackle unmet medical needs, announced today that the Company, in a privately-negotiated transaction, repurchased all outstanding US$13,500,000 in aggregate principal amount of the 8.00 per cent. convertible bonds due 2019 (“Convertible Bonds”) from Peace Range Limited, a wholly owned subsidiary of Adamas Ping An Opportunities Fund LP, together with certain subscription right to subscribe up to the principal amount of the Bond at a US$12.17 (subject to adjustment) on or before December 17, 2019 (“Subscription Right”). The total consideration of the repurchase of the Convertible Bonds and the Subscription Right was US$13.6 million in cash, excluding accrued interest. The repurchase of the Convertible Bonds and Subscription Right was executed by Aptorum Investment Holding Limited, a wholly owned subsidiary
The Energy Efficient Mortgages Initiative is Defining the Future: a Greener Future24.4.2019 11:03:00 EEST | Tiedote
Today, the Energy Efficient Mortgages (EEM) Initiative is taking another important step toward its objective of delivering a standardised European framework and data collection architecture for energy efficient mortgages. The EEM Initiative is organising a series of high-profile EEM Initiative events in Riga, Latvia, gathering together relevant stakeholders from the financing and banking communities, property and construction sectors, as well as policymakers to discuss how to align market best practices and debate the next steps with a view to securing market development in relation to energy efficient mortgages, in line with the overall objectives of the Capital Markets Union (CMU). These events are being organised alongside the 29th ECBC Plenary Meeting, where the covered bond industry is celebrating another milestone in the form of the adoption of the Covered Bond Legislative Package (read more (link to be added) ). To recall, the objective of the Initiative is to stimulate and fina
Leading P&G Brands Including Pampers, Ariel and Herbal Essences Expand Leadership in Responsible Consumption24.4.2019 11:00:00 EEST | Tiedote
The Procter & Gamble Company (NYSE:PG) today detailed the roadmap and actions its leadership brands are taking to increase positive impact on society and the environment through its “Brand 2030” criteria. Today at the Sustainable Brands Paris conference, senior Company officials presented a forward-looking framework, including innovation strategies that will inspire and enable responsible consumption for the five billion consumers served by P&G each day. P&G leading brands including Pampers®, Ariel® and Herbal Essences® are progressing in adopting this framework with actions and commitments that will help accelerate sustainable lifestyles. “Consumers are no longer willing to compromise performance for living sustainably and they expect brands to take meaningful action in solving some of the most complex challenges facing the world,” said Marc Pritchard, P&G’s Chief Brand Officer. “This is why P&G is focused on reinventing marketing to use the reach and voice of our brands as a force fo
UNAOC and BMW Group Launch Search for Innovative Projects Promoting Intercultural Dialogue and Understanding24.4.2019 10:30:00 EEST | Tiedote
The United Nations Alliance of Civilizations (UNAOC) and the BMW Group launched the call for applications of the sixth edition of the Intercultural Innovation Award. Grassroots initiatives that encourage intercultural understanding through innovative methods, with the aim of alleviating identity-based conflicts around the world, are encouraged to apply online at interculturalinnovation.org. This year, the deadline for applications is 31 May, at 5:00 PM EDT. Following a competitive process, ten organizations will be selected to receive the Intercultural Innovation Award. Based on their needs, recipients will receive a monetary grant to help their projects expand and replicate (total funding available in 2019: USD 100,500). They will also benefit from a one-year mentoring program, which will include capacity-building training in a multitude of areas, from communications to fundraising and project management. Recipients of the Intercultural Innovation Award will also become members of Int
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme