ZS Pharma to Present Data from Phase 3 Trial of ZS-9 in Late-Breaking Poster Presentation at the European Renal …

COPPELL, Texas–(BUSINESS WIRE)–

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, its investigational
treatment for hyperkalemia, will be presented as a late-breaking
clinical trials poster presentation during the 51st European
Renal Association-European Dialysis and Transplant Association
(ERA-EDTA) Congress being held in Amsterdam from May 31 to June 3, 2014.

The Company’s 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.
Results demonstrated that both the 5g and 10g doses of ZS-9,
administered once daily, controlled potassium at normal levels in
hyperkalemic patients.

Late-Breaking Poster Presentation

ZS-9 Once-Daily Consistently Maintained Normokalaemia Across
Subgroups in a Phase 3 Multicenter, Randomised, Double-Blind,
Placebo-Controlled Trial of Patients with Hyperkalaemia

 
Presenter:   David K. Packham, MB, BS, MD, MRCP, FRACP, Melbourne Renal Research
Group, Royal Melbourne Hospital, Australia
Session: Late-Breaking Clinical Trials, Poster MP758
Date: Monday, June 2, 7:30 – 10:45 a.m. CEST
 

Poster Presentations

In addition to the late-breaking poster presentation, data about
ZS-9 will be presented in seven posters during a Poster Session on
Sunday, June 1, from 7:30 – 10:45 a.m. CEST.
 
Poster SP320: Acute-Phase Efficacy in a Phase 3 Multicenter, Randomised,
Double-Blind, Placebo-Controlled Trial of ZS-9 in Patients with
Hyperkalaemia
Presenter: Mohamed A. El-Shahawy, MD, MPH, MHA, FASN, Clinical Professor of
Medicine, Keck-USC School of Medicine, Director, Academic Medical
Research Institute, Los Angeles, Calif., USA
 
Poster SP331: Extended Efficacy of ZS-9 Once-Daily in a Phase 3 Multicenter,
Randomised, Double-Blind, Placebo-Controlled Trial of Patients with
Hyperkalaemia
Presenter: Simon D. Roger, MD, FRACP, Department of Renal Medicine, Gosford
Hospital, Australia
 
Poster SP337: Safety and Tolerability of ZS-9 in a Multicenter, Randomised,
Double-Blind, Placebo-Controlled Trial in Patients with Hyperkalaemia
Presenter: David K. Packham, MD, MB, BS, MD, MRCP, FRACP, Melbourne Renal
Research Group, Royal Melbourne Hospital, Australia
 
Poster SP324: Efficacy of ZS-9 in Patients Receiving RAAS Therapy: A Subgroup
Analysis of a Phase 3 Multicenter, Randomised, Double-Blind,
Placebo-Controlled Trial
Presenter: Simon D. Roger, MD, FRACP, Department of Renal Medicine, Gosford
Hospital, Australia
 
Poster SP321: Phase 3, Multicenter, Randomised, Double-Blind, Placebo-Controlled
Trial of ZS-9: Acute Efficacy by Baseline Serum Potassium Levels
Presenter: Bhupinder Singh, MD, Assistant Clinical Professor, Department of
Medicine, Creighton University School of Medicine, and Chief Medical
Officer, Apex Research of Riverside, Calif., USA
 
Poster SP001: Optimizing the ZS-9 Potassium Ion Trap: Pore Size and Thermodynamics
Presenter: Alex Yang, MD, Xelay Acumen, Belmont, Calif., USA
 
Poster SP251: Acid-Base Balance in Phase 2 and Phase 3 Trials of ZS-9 for
Hyperkalaemia for Hyperkalaemia in Patients with Chronic Kidney
Disease
Presenter: Bhupinder Singh, MD, Assistant Clinical Professor, Department of
Medicine, Creighton University School of Medicine, and Chief Medical
Officer, Apex Research of Riverside, Calif., USA

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 suggesting 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.

Source Article from http://finance.yahoo.com/news/zs-pharma-present-data-phase-150000875.html
ZS Pharma to Present Data from Phase 3 Trial of ZS-9 in Late-Breaking Poster Presentation at the European Renal …
http://finance.yahoo.com/news/zs-pharma-present-data-phase-150000875.html
http://news.search.yahoo.com/news/rss?p=pharma
pharma – Yahoo News Search Results
pharma – Yahoo News Search Results



コメントを残す

メールアドレスが公開されることはありません。 * が付いている欄は必須項目です

次のHTML タグと属性が使えます: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>