Clinical Trial Indicates Promising Results for Potential New Treatment for Hyperkalemia
KANSAS CITY, Mo. (Nov. 17, 2014) — Mikhail N. Kosiborod, M.D., cardiologist at Saint Luke's Mid America Heart Institute, Professor of Medicine at the University of Missouri-Kansas City, and the lead clinical investigator in the HARMONIZE trial, today presented detailed results from HARMONIZE (ZS004), the second positive Phase 3 clinical trial of sodium zirconium cyclosilicate (ZS-9), at the American Heart Association Scientific Sessions during the late-breaking Clinical Science Special Reports Session. The study was sponsored by ZS Pharma, a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders. In addition to the presentation, the study results were simultaneously published today in the Journal of the American Medical Association (JAMA).
ZS-9 is being developed to treat hyperkalemia, a potentially life threatening condition of dangerously high potassium levels in the blood. Hyperkalemia is common in patients with kidney disease, heart failure, diabetes or those who have a combination of the three. This condition has been increasing in prevalence in recent years as all three of these disease states continue to grow.
For several decades there have been few options to effectively treat hyperkalemia, particularly in the outpatient setting. The promising results of the HARMONIZE trial suggest that, if approved by the regulatory agencies, ZS-9 could potentially be an effective and well tolerated option for this condition both for acute treatment and over an extended period.
“Today’s HARMONIZE results suggest that in addition to rapidly lowering potassium levels to normal range in patients with hyperkalemia, ZS-9 may be used over an extended treatment period to maintain normal potassium levels” , said Dr. Kosiborod. “I believe that these exciting findings have the potential to shift the current paradigm for how hyperkalemia is managed among various at-risk patient groups including patients on RAASi therapy - which can potentially delay progression of chronic kidney disease and improve morbidity and mortality in patients with heart failure but which is also known to cause hyperkalemia.”
The HARMONIZE (HyperkAlemia RandoMized interventiON multI-dose ZS-9 maintEnance) study, led by ZS Pharma, is a global, prospective, randomized, double-blind, placebo-controlled trial that enrolled patients with hyperkalemia with no upper limit on serum potassium at entry. Patients included those with chronic kidney disease, heart failure, diabetes and those on renin angiotensin aldosterone system (RAAS) inhibitor therapy from a range of ethnic backgrounds.
“The Phase 3 results suggest that ZS-9, if approved, could potentially be an effective, well-tolerated and much needed treatment for hyperkalemia,” said Robert Alexander, Ph.D., Chief Executive Officer of ZS Pharma.
The complete study results may be found in the Journal of the American Medical Association: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2014.15688
About Saint Luke’s Mid America Heart Institute
Saint Luke’s Mid America Heart Institute, a member of Saint Luke’s Health System and a teaching affiliate of the University of Missouri-Kansas City, is one of the preeminent cardiovascular programs in the country. Its legacy of innovation began more than 25 years ago when it opened as the nation’s first heart hospital. Since then, the Heart Institute has earned a world-wide reputation for excellence in the treatment of heart disease, including interventional cardiology, cardiovascular surgery, imaging, heart failure, transplant, heart disease prevention, women’s heart disease, electrophysiology, outcomes research, and health economics. With more than 50 full-time board certified cardiovascular specialists on staff, the Heart Institute offers one of the largest heart failure/heart transplant programs in the country, has the largest experience with transcatheter aortic valve replacement in the Midwest, and is a global teaching site for the newest approaches to opening challenging blocked arteries using minimally invasive techniques.
About ZS Pharma
ZS Pharma is a publicly-traded, specialty pharmaceutical company based in Coppell, Texas. ZS Pharma’s lead therapeutic candidate, ZS-9, is an investigational treatment for hyperkalemia that is being evaluated in late-stage clinical trials to demonstrate its ability to safely and effectively remove excess potassium from the blood and maintain normal potassium levels. ZS Pharma is also pursuing the discovery of additional drug candidates that utilize its novel selective ion-trap technology for the treatment of kidney and liver diseases. Additional information is available at www.zspharma.com.