ZS Pharma: Positive Results From Trial Of ZS-9 In Patients With Hyperkalemia

(RTTNews) - ZS Pharma (ZSPH) Tuesday announced positive top-line results from HARMONIZE (ZS004), its second Phase 3 clinical trial of ZS-9 (sodium zirconium cyclosilicate), a novel investigational treatment for hyperkalemia.

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 in November during the late-breaking Clinical Science Special Reports Session.

The ZS-9 clinical program is designed to investigate the treatment of acute and chronic hyperkalemia, regardless of underlying cause.

The company plans to file a New Drug Application with the U.S. Food and Drug Administration and a Marketing Authorization Application with the European Medicines Agency in the first half of 2015.

Hyperkalemia, or higher than normal potassium levels, is a potentially life-threatening metabolic condition that can lead to cardiac arrhythmia and sudden cardiac death.