AstraZeneca to present new data demonstrating breadth of research portfolio in renal disease at ASN Kidney Week 2018

35 scientific data presentations and publications, including new evidence for Lokelma in hyperkalaemia and Farxiga on renal endpoints in type-1 diabetes

Latest data on potential new medicine roxadustat for anaemia in chronic kidney disease and early-stage findings from multiple investigational treatments

AstraZeneca will present new research spanning the Company’s Cardiovascular, Renal and Metabolism (CVRM) therapy area at the American Society of Nephrology (ASN) Kidney Week Annual Meeting in San Diego, US, 23-28 October 2018.

ASN Kidney Week is a landmark meeting for AstraZeneca, which will provide new and in-depth research aiming to inform clinical practice across the renal treatment paradigm, while also advancing science that uncovers commonalities and potential treatment targets across cardiovascular, renal and metabolic diseases.

Danilo Verge, Vice President, Cardiovascular, Renal and Metabolism, Global Medical Affairs at AstraZeneca said: “The data we are presenting at ASN Kidney Week demonstrate our ambition to advance treatment for patients with chronic kidney disease and its associated complications. We are exploring solutions to help address unmet medical need, including disease modification during early-stage diagnosis to managing potentially life-threatening complications as patients progress to dialysis and end-stage renal disease.”

New research will include data from the Phase III HARMONIZE Global trial to evaluate the safety and efficacy of Lokelma (sodium zirconium cyclosilicate) for the treatment of patients with hyperkalaemia in Japan, Russia, Korea and Taiwan. These findings add to the growing body of evidence for Lokelma and will support regulatory filings in those markets.

Building awareness of clinical practice with real-world evidence and clinical data

AstraZeneca will present and publish 11 abstracts that focus on the treatment and management of hyperkalaemia, including an analysis of real-world dosing practices of renin-angiotensin-aldosterone system (RAAS) inhibitors and their association with risk of adverse clinical events in patients with chronic kidney disease (CKD).

The risk of hyperkalaemia, a serious condition characterised by abnormally high levels of potassium in the blood, associated with cardiovascular, renal and metabolic diseases, increases significantly for patients with CKD and those on common medications for heart failure (HF), such as RAAS inhibitors.

Evaluating unmet needs in anaemia management for CKD patients

AstraZeneca will provide new data on roxadustat, as well as additional research on the treatment paradigm of anaemia in CKD patients. Roxadustat is a potential first-in-class new medicine and orally-administered small molecule currently in Phase III development for anaemia associated with CKD in dialysis-dependent(DD) and non-dialysis dependent (NDD) patients.

Data from large registries around the globe, including US, China and countries in Europe, indicate a strong association between anaemia and poor quality of life, though many NDD patients with anaemia remain untreated due to concerns with the safety of the current standard of care, erythropoiesis stimulating agents (ESAs).1

Early science and investigational combination treatments

Delving deep into the science and molecular basis of CVRM diseases, AstraZeneca’s Innovative Medicines and Early Development (IMED) Biotech Unit will present eight abstracts focusing on mechanisms of obesity, HF and renal disease.

New modalities provide an opportunity to design therapeutics for disease mechanisms previously considered difficult to address, and are a key part of our early science strategy. Our research, in collaboration with Ionis Pharmaceuticals, on antisense oligonucleotides (ASO) as a potential modality for new targets in CKD will be an oral presentation, with an additional poster that furthers our understanding of the science behind this new modality. An additional key abstract investigates distinct endothelial cell subpopulations using cutting-edge single cell RNA-sequencing analysis.

Early scientific data on verinurad, an investigational treatment for uric acid elimination, will be presented. Expanding on our existing portfolio, a poster presentation will describe the investigation of Farxiga (dapagliflozin) on serum uric acid when given in combination with verinurad and febuxostat.

For a complete list of AstraZeneca data presentations during Kidney Week, please access the ASN website.

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NOTES TO EDITORS

About Hyperkalaemia

The risk of hyperkalaemia increases significantly for patients with CKD and for those who take common medications for HF such as RAAS inhibitors, which can increase potassium in the blood. Hyperkalaemia occurs in 23% to 47% of patients with CKD and/or HF, with an estimated 200 million and 38 million people, respectively, living with each condition worldwide. Hyperkalaemia may lead to cardiac arrest and death, with mortality being up to 30% in patients with severe hyperkalaemia.

About Anaemia in CKD

Anaemia is a serious medical condition in which patients have insufficient red blood cells and low levels of haemoglobin (“Hb”), a protein in red blood cells that carries oxygen to cells throughout the body.^1,2 Anaemia is associated with increased risk of hospitalisation, cardiovascular complications and death.^2,3 In addition, anaemia frequently causes significant fatigue, cognitive dysfunction, and decreased quality of life.^4,5 Severe anaemia is common in patients with CKD and other serious illnesses. Even when it accompanies prevalent and serious diseases, anaemia is often not effectively treated.

Anaemia is particularly prevalent in patients with CKD, which itself affects more than 200 million people worldwide and is generally a progressive disease characterised by gradual loss of kidney function that may eventually lead to kidney failure.

According to the United States Renal Data System, a majority of dialysis-eligible CKD patients in the US are currently on dialysis. Of the approximately 475,000 patients receiving dialysis in the US, around 83% are being treated with ESAs for anaemia. In clinical practice, patients typically do not receive ESA treatment for their anaemia until they initiate dialysis.

About the DapaCare Clinical Programme

The DapaCare clinical programme will explore the cardiovascular (CV) and renal profile of Farxiga in people with and without type-2 diabetes. DapaCare will enrol nearly 30,000 patients in randomised clinical trials (Phase III trials: Dapa-HF, DELIVER and Dapa-CKD) and is supported by a multinational real-world evidence study. The programme will generate data across a spectrum of people with established CV disease, CV risk factors and varying stages of renal disease, both with and without type-2 diabetes. DapaCare underscores our commitment to following the science to pursue a holistic patient approach to help address the multiple risk factors associated with CV, renal and metabolic diseases.

About AstraZeneca in Cardiovascular, Renal & Metabolism (CVRM)

Cardiovascular, renal and metabolism together form one of AstraZeneca’s main therapy areas and a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information, please visit www.astrazeneca.comand follow us on Twitter @AstraZeneca.

References

1 Jackson, J., van Haalen, H., Salehi, H., Milligan, G., Moon, R. Anemia Treatment Patterns in Chronic Kidney Disease: Results From Three International Surveys Among Physicians [abstract]. American Society of Nephrology; 2018 Oct 26; San Diego; Abstract nr TH-PO249. https://www.asn-online.org/education/kidneyweek/2018/program-abstract.aspx?controlId=3023640

2 National Kidney Foundation. “Managing Anaemia When You Have Kidney Disease or Kidney Failure.” 2014.

3 National Institute of Diabetes and Digestive and Kidney Diseases. “Anaemia in Chronic Kidney Disease.” 2014.

4 KDOQI Clinial Practice Guidelines and Clinical Practice Recommendations for Anaemia in Chronic Kidney Disease. Am J Kidney Dis. 2006 May;47(5):S1-S132

5 American Heart Association. “Life-Threatening Electrolyte Abnormalities.” 2005; Circulation. 2005;112:IV-121-IV-125