ZS Pharma to Present Data from Phase 3 Trial of ZS-9 in Late-Breaking Oral Presentation at National Kidney Foundation’s 2014 Spring Clinical Meetings

COPPELL, Texas--()--ZS Pharma, a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, today announced that data from a pivotal Phase 3 trial of ZS-9, an investigational treatment for hyperkalemia, will be presented as a late-breaking clinical trial oral presentation at the National Kidney Foundation’s 2014 Spring Clinical Meetings in Las Vegas. 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.

Oral Presentation
ZS-9 for serum potassium reduction in hyperkalemic patients 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.

Date:

Friday, April 25, 9:30-11:00 a.m. PT

Location:

MGM Grand Hotel, Room 121

Poster Presentations
In addition to the late-breaking oral presentation, new data from the Company’s Phase 2 trial, ZS002, a randomized, double-blind, placebo-controlled trial of ZS-9, will be presented at a Poster Session on Wednesday, April 23, from 6:00-7:30 p.m. PT at the MGM Grand Hotel in the Exhibit Hall. In total, five ZS-9 posters are being presented at the aforementioned Poster Session, including:

Poster 205:

   

Reduction in serum K+ with ZS-9 in CKD patients with hyperkalemia on RAAS inhibitors (RAASi)

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.

 

Poster 262:

In vitro ion exchange capacity and selectivity of ZS-9, a novel, selective cation trap for the treatment of hyperkalemia

Presenter:

Alex Yang, M.D., Xelay Acumen, Belmont, Calif.

 

Poster 426:

Individualizing ZS-9 dosing for serum potassium reduction in hyperkalemic patients from a Phase 3 multicenter, randomized, double-blind, placebo-controlled trial

Presenter:

Philip Lavin, Ph.D., Boston Biostats Research Foundation, Framingham, Mass.

All abstracts are available on the National Kidney Foundation's website:
http://www.kidney.org/news/meetings/clinical/abstract/index.cfm

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 a 10 mg dose of ZS-9 rapidly reduced serum potassium in hyperkalemic patients to normal levels within 48 hours and maintained potassium in the normal range with once-daily dosing. 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.

About Hyperkalemia
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.

Contacts

BrewLife
Denise Powell, 510-703-9491
dpowell@brewlife.com

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Contacts

BrewLife
Denise Powell, 510-703-9491
dpowell@brewlife.com