Phase III trial of ZS 9 meets endpoint in Hyperkalemia-ZS Pharma

ZS Pharma has announced positive top-line results from HARMONIZE (ZS004), its second Phase III clinical trial of ZS 9 (sodium zirconium cyclosilicate), a novel investigational treatment for Hyperkalemia. HARMONIZE is a global, prospective, randomized, double-blind, placebo-controlled trial that enrolled 258 patients with hyperkalemia with no upper limit on serum potassium (K+) at entry. Preliminary analyses of the results showed that all three doses (5g, 10g, and 15g) of once daily ZS 9 met the primary endpoint, demonstrating that ZS 9 prevented recurrence of Hyperkalemia when compared with placebo over a 28-day treatment period.

Safety, tolerability and adverse events are generally consistent with previous ZS 9 clinical studies. The data will be presented at the American Heart Association Scientific meeting. The Company 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.