— ZS005 study accepted as late-breaking poster presentation at American Society of Nephrology’s Kidney Week 2015 —
— Additional ZS-9 and hyperkalemia poster presentations also highlighted —
SAN MATEO, Calif., Oct. 19, 2015 (GLOBE NEWSWIRE) — ZS Pharma, Inc. (Nasdaq:ZSPH), today announced that data about ZS-9 (sodium zirconium cyclosilicate), an investigational treatment for hyperkalemia, will be presented in multiple posters during American Society of Nephrology’s (ASN) Kidney Week 2015.
Details for the presentations are outlined below:
| Late-Breaking Poster Presentation | |
| Poster: | Long-Term (52-Week) Efficacy and Safety of ZS-9 in the Treatment of Hyperkalemia: Interim Results From a Phase 3 Open-Label, Multi-Center, Multi-Dose Maintenance Study |
| Presenter: | James A. Tumlin, M.D., C.C.R.P., Nephrologist, Associate Professor of Medicine at the University of Tennessee Chattanooga, Medical Director of Southeast Renal Research Institute (SERRI) and President, Nephronet |
| Session: | High-Impact Clinical Trials |
| Date: | Saturday, November 7, 10:00 a.m. – 12:00 p.m. PT |
| Additional Poster Presentations | |
| Poster: | Assessment of Systemic Absorption of Sodium Zirconium (Zr) Cyclosilicate (ZS-9): Blood and Urine Zr Concentration in Dogs During a 9-month Oral Toxicity Study |
| Presenter: | Fiona Stavros, Ph.D., Vice President, Nonclinical Development, ZS Pharma, Inc. |
| Session: | Fluid, Electrolyte, and Acid-Base Disorders |
| Date: | Saturday, November 7, 10:30 a.m. – 12:00 p.m. PT |
| Poster: | Frequency of Hyperkalemia Events in Dialysis Patients in a Large Dialysis Organization |
| Presenter: Akeem Yusuf, Ph.D., Senior Pharmacoepidemiologist, Chronic Disease Research Group, Minneapolis Medical Research Foundation | |
| Session: | Dialysis: Epidemiology, Outcomes, and Clinical Trials: Noncardiovascular |
| Date: | Thursday, November 5, 10:00 a.m. – 12:00 p.m. PT |
| Poster: | Serum Potassium Levels and Mortality in Hemodialysis Patients |
| Presenter: | Akeem Yusuf, Ph.D., Senior Pharmacoepidemiologist, Chronic Disease Research Group, Minneapolis Medical Research Foundation |
| Session: | Dialysis: Epidemiology, Outcomes, and Clinical Trials: Noncardiovascular |
| Date: | Thursday, November 5, 10:00 a.m. – 12:00 p.m. PT |
About ZS-9 (sodium zirconium cyclosilicate)
ZS-9 is an insoluble, non-absorbed zirconium silicate with a clearly defined three-dimensional crystalline lattice structure that was designed to preferentially trap potassium ions. The potassium selectivity of ZS-9 is hypothesized to enable high in-vitro binding capacity for potassium ions even in the presence of other competing ions. ZS-9 has been studied in three double-blind, placebo controlled trials and in two 12 month open-label studies in patients with hyperkalemia. ZS-9 is an investigational product that is not approved by the U.S. Food and Drug Administration (FDA) or European regulatory agencies for any indication.
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 results from the inability of the kidneys to excrete potassium, impairment of mechanisms that transport potassium into cells, or a combination of both factors. The diseases that cause hyperkalemia vary, but the most common are chronic kidney disease (CKD), diabetes, heart failure (HF) and side effects from cardio-renal protective drug therapy, such as renin angiotensin aldosterone system (RAAS) inhibitors.
About ZS Pharma
ZS Pharma is a publicly-traded (Nasdaq:ZSPH), biopharmaceutical company focused on the development and commercialization of highly selective, non-absorbed drugs to treat renal, cardiovascular, liver and metabolic disorders. ZS Pharma’s lead therapeutic candidate, ZS-9 (sodium zirconium cyclosilicate), is an investigational agent that has been submitted to the FDA for potential approval for the treatment of hyperkalemia. The ZS-9 Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is May 26, 2016. ZS Pharma is also pursuing the discovery of additional drug candidates that utilize its novel selective ion-trap technology. Additional information about ZS Pharma is available at www.zspharma.com.
Forward-Looking Statements
ZS Pharma cautions you that this press release contains forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about: our expectations regarding the timing of the review of an NDA by the FDA, submitting an MAA to the EMA, the likelihood of regulatory approval of ZS-9, our expectations regarding our ability to successfully commercialize ZS-9, if approved, estimates of our expenses, future revenue, capital requirements and needs for additional financing, our ability to produce ZS-9 in commercial quantities in higher capacity reactors, the initiation, timing, progress and results of future nonclinical studies, clinical trials and research and development programs, and our financial performance. Any forward looking statements in this press release are based on management’s current expectations, estimates, forecasts, and projections about our business and the industry in which we operate and management’s beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this press release may turn out to be inaccurate. Factors that may cause actual results to differ materially from expectations include, among other things, those listed under Part I, Item 1A. Risk Factors in ZS Pharma’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission August 6, 2015 and its other reports, which are available from the SEC’s website (http://www.sec.gov) and on ZS Pharma’s website (http://www.zspharma.com) under the heading “Investors”. All forward‐looking statements are qualified in their entirety by this cautionary statement and speak only as of the date of this press release. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. You should, however, review the factors and risks described in the reports we will file from time to time with the SEC after the date of this press release.
CONTACT: ZS Pharma Contacts
Myesha Edwards (Investors)
ZS Pharma
650.753.1854
[email protected]
Denise Powell (Media)
Red House Consulting
510.703.9491
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