US-based biopharmaceutical firm ZS Pharma has reported positive top-line results from its second Phase III clinical trial of ZS-9 (sodium zirconium cyclosilicate), a new investigational treatment for hyperkalemia.
Results from the Phase III trial HARMONIZE (ZS004) showed that all three doses 5g, 10g and 15g of once daily ZS-9 met the primary endpoint, showing that ZS-9 prevented recurrence of hyperkalemia when compared with placebo over a 28-day treatment period.
The global, prospective, randomised, double-blind, placebo-controlled trial enrolled 258 patients with hyperkalemia with no upper limit on serum potassium (K+) at entry.
According to the company, safety, tolerability and adverse events are generally consistent with previous ZS-9 clinical trials.
ZS Pharma chief executive officer Robert Alexander said: "With the completion of the HARMONIZE trial, we remain on track to submit NDA and MAA filings for ZS-9 in the first half of 2015."
The trial included patients with chronic kidney disease (CKD), heart failure (HF), diabetes and those on renin angiotensin aldosterone system (RAAS) inhibitor therapy.
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In the open-label induction phase of the trial, patients were given 10g of ZS-9 three times daily for 48 hours and were monitored to establish the speed and magnitude of serum potassium reduction.
The ZS-9 clinical programme is designed to investigate the treatment of acute and chronic hyperkalemia, regardless of underlying cause.
The company has completed ZS003, a 753-patient Phase III trial, which showed that ZS-9 rapidly reduced serum potassium in hyperkalemic patients to normal levels within the 48-hour Acute Phase and then controlled potassium in the normal range throughout the 12-day Extended Treatment Phase.
Together with HARMONIZE, the company is also carrying out ZS004E, an extension trial that will generate longer-term open-label safety and tolerability data in patients who participated in HARMONIZE.
ZS005, an additional long-term safety study is also being conducted to evaluate the ability of ZS- 9 to restore and maintain normal serum potassium levels in patients with hyperkalemia over at least one-year of dosing.