COPPELL, Texas--(BUSINESS WIRE)--ZS Pharma, a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, today announced that sub-group analysis data from a pivotal Phase 3 trial of ZS-9, an investigational treatment for hyperkalemia, will be presented as a late-breaking oral presentation at the 2014 American Society of Hypertension (ASH) Annual Scientific Meeting and Exposition at the New York Hilton Midtown in New York City.
The Phase 3 trial, ZS003, assessed the safety and efficacy of ZS-9 in treating patients with hyperkalemia, a life-threatening condition that is characterized by higher than normal levels of potassium (K+) in the blood serum. To date, Phase 2 and Phase 3 clinical trials of ZS-9 have demonstrated significant, rapid and sustainable reductions in serum potassium with a safety profile similar to placebo. The ZS003 sub-group analysis, which was pre-specified, specifically looked at patients taking renin-angiotensin-aldosterone system inhibitor (RAASi) drug therapies, including angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs) and aldosterone blockers. Results demonstrated that both the 5g and 10g doses of ZS-9, administered once daily, controlled potassium at normal levels in these hyperkalemic patients.
RAASi therapy is known to cause hyperkalemia and/or exacerbate existing hyperkalemia in patients with chronic kidney disease (CKD) and congestive heart failure (CHF). As a result, many patients with CKD and CHF who could benefit from RAASi therapy cannot tolerate the recommended dose, which may lead to sub-optimal treatment of the underlying disease and place these patients at greater risk of disease progression.
Late-Breaking Oral Presentation
ZS-9 Once-Daily Maintained Serum K+ in Hyperkalemic Subjects on RAAS Therapy: Subgroup Analysis from a Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Presenter: Bhupinder Singh, M.D., nephrologist, Assistant Clinical Professor, Department of Medicine, Creighton University School of Medicine, and Chief Medical Officer, Apex Research of Riverside, Calif.
Session: Late-Breaking Clinical Research
Date: Tuesday, May 20, 7:30-9:30 a.m. ET
In addition to the late-breaking oral presentation, data about ZS-9 will be presented in three posters during the Poster Session on Monday, May 19, from 12:00-1:00 p.m. ET in the Exhibit Hall Area.
About ZS-9’s Clinical Development Program
The ZS-9 clinical program is designed to investigate the treatment of acute and chronic hyperkalemia, regardless of underlying cause. ZS Pharma recently completed a 753-patient Phase 3 study, ZS003, which showed that ZS-9 rapidly reduced serum potassium in hyperkalemic patients to normal levels within the 48 hour Induction Phase and then controlled potassium in the normal range throughout the 12 day Extended Treatment Phase. In addition, the study provided evidence that ZS-9 is safe and well-tolerated with an adverse event profile similar to placebo.
In 2014, ZS Pharma initiated ZS004, its second Phase 3 clinical trial of ZS-9. ZS004 is a randomized, double-blind, placebo-controlled study designed to confirm, over a longer treatment period, the positive results previously reported for ZS003. In addition to ZS004, the Company plans to initiate an additional long-term safety study, ZS005, in the second quarter of 2014, and plans to file a New Drug Application with the United States Food and Drug Administration and a Marketing Authorization Application with the European Medicines Agency in the first half of 2015.
Hyperkalemia, or higher than normal potassium levels (typically defined as a serum potassium level >5 mEq/L), is a life-threatening metabolic condition that can lead to cardiac arrhythmia and sudden cardiac death. Hyperkalemia is characterized by abnormally high concentrations of potassium in the blood resulting from the inability of the kidneys to excrete potassium, impairment of mechanisms that transport potassium into cells, or a combination of both factors. The causes of hyperkalemia vary but the most common are chronic kidney disease (CKD), diabetes, congestive heart failure (CHF) and side effects from cardio-renal protective drug therapy, such as renin angiotensin aldosterone system (RAAS) inhibitors.
About ZS Pharma
ZS Pharma is a privately-held, 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.