ZS-9 (sodium zirconium cyclosilicate) Phase III long-term safety and efficacy data presented at ASN Kidney Week 2017



ZS005 trial demonstrated maintenance of potassium control of ZS-9 for up to 12 months in patients with hyperkalaemia

ZS005 confirmed a safety profile of ZS-9 consistent with other studies
 

2 November 2017

AstraZeneca today announced the full results of the Phase III ZS005 open label trial examining the long-term safety and efficacy of ZS-9 (sodium zirconium cyclosilicate) in treating patients with hyperkalaemia for up to 12 months. These data were presented at the American Society of Nephrology's (ASN) Kidney Week 2017.

Hyperkalaemia is a condition defined by elevated potassium levels in the blood, often caused by cardiovascular, renal and metabolic diseases.[i] The ZS005 data show that ZS-9 rapidly reduced serum potassium levels in patients with hyperkalaemia and maintained blood serum potassium at normal levels (normokalaemia) for up to 12 months.2

Patients with hyperkalaemia who achieved normokalaemia (mean potassium levels of 3.5-5.0 mEq/L) during the first 24 to 72 hours (99.3%; n=746/751), were eligible for the extended one-year maintenance phase. The data show that mean potassium levels of ≤5.1 or ≤5.5mEq/L were maintained during the extended phase, in 88% and 99% of patients respectively from month 3 to month 12. [ii]

The safety profile was consistent with prior studies for this patient population. Common adverse effects (among ≥5% of patients) reported during the extended dosing phase were hypertension, peripheral edema, urinary tract infection, nausea, constipation, anemia and upper respiratory tract infection.2

Dr. Steven Fishbane, Hofstra Northwell School of Medicine, Great Neck, NY, USA, and primary investigator of the ZS005 trial, said: “About 50 percent of emergency room visits for hyperkalaemia result in hospital admission, creating a clinical and economic burden for patients and healthcare professionals.[iii] Given the limited current therapy options, ZS-9 has the potential to address the unmet need for the well-tolerated and effective long-term treatment of hyperkalaemia.”

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases (CVMD), Global Medicines Development, AstraZeneca, said: “The ZS005 trial results show potential for ZS-9 to address the burden of hyperkalaemia in adults in a chronic setting. We continue to explore this area of high unmet need as part of our commitment to transform the management of cardio-renal diseases and their complications.”
 

NOTES TO EDITORS

About ZS-9 (sodium zirconium cyclosilicate)

ZS-9 (sodium zirconium cyclosilicate) is an insoluble, non-absorbed zirconium silicate compound in clinical development and acts as a highly selective potassium-removing agent. It is administered orally and is odourless and tasteless. Clinical trials indicate that it is stable at room temperature. It has been studied in three double-blind, placebo-controlled trials and in one 12-month open label clinical trial in patients with hyperkalaemia, representing more than 1,800 patients treated to date.

About Hyperkalaemia

Hyperkalaemia (high potassium levels in the blood serum) occurs in 23 to 47% of patients with chronic kidney disease and/or chronic heart failure, and may lead to cardiac arrest and death. Treatment with common heart medicines can also be responsible for increases in hyperkalaemia.

About AstraZeneca in Cardiovascular, Renal & Metabolic Diseases (CVMD)

Cardiovascular, renal and metabolic diseases together form one of AstraZeneca’s main therapy areas and platforms for future growth. By following the science to understand more clearly the underlying links between the heart, kidney 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 CVMDs and even regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CVMD 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 main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

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

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References

1 Gumz ML, Rabinowitz L, Wingo CS. An integrated view of potassium homeostasis. N Engl J Med. 2015;373(1):60-72.

2 Fishbane S, Pergola PE, Packham DK, et al. Maintained efficacy and safety of sodium zirconium cyclosilicate for hyperkalemia: 12-month, open-label, phase 3 study. Poster presentation at: American Society of Nephrology Kidney Week 2017; November 2017; New Orleans, LA.  Abstract #2759765.

3 Dunn JD, Benton WW, Orozco-Torrentera E, Adamson RT. The burden of hyperkalemia in patients
with cardiovascular and renal disease. Am J Manag Care. 2015 Nov;21(15): s307.
http://www.ajmc.com/journals/supplement/2015/A577_Nov15_Hypekalemia/a577_nov15_hyperkalemia/. Accessed October 16, 2017.