ZS Pharma, a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, has begun enrolling patients in ZS005, a Phase 3 open-label, 12-month, long-term maintenance studyof ZS-9, an investigational treatment for hyperkalemia. This Phase 3 trial is designed to further add to the clinical experience to date by demonstrating the safety and tolerability of ZS-9 and its ability to restore and maintain normal serum potassium levels in patients with hyperkalemia over at least one year of dosing.The Company plans to file a New Drug Application with the United States Food and Drug Administration and a Marketing Authorisation Application with the European Medicines Agency in the first half of 2015.
The ZS-9 clinical programme 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.
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