ZS Pharma Offers Top-Line Results from HARMONIZE (ZS004) Phase 3 Trial of ZS-9

ZS Pharma

, a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, today 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. "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. Importantly, our clinical experience with ZS-9 now includes nearly 1000 patients, some of whom have been treated with ZS-9 for over 5 months," said Robert Alexander, Ph.D., Chief Executive Officer of ZS Pharma, "We are excited to announce these preliminary results and look forward to having the lead study investigator, Mikhail Kosiborod, M.D., share the full data at a late-breaking session at the American Heart Association meeting." HARMONIZE (ZS004) Phase 3 Study Design The HARMONIZE (HyperkAlemia RandoMized interventiON multI-dose ZS-9 maintEnance) study 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. Patients included those with chronic kidney disease (CKD), heart failure (HF), diabetes and those on renin angiotensin aldosterone system (RAAS) inhibitor therapy. In the open-label induction phase of the study, patients received 10g of ZS-9 administered three times daily for 48 hours and were monitored to establish the speed and magnitude of serum potassium reduction. Patients who achieved normokalemia (K+ levels between 3.5 and 5 mEq/L) were randomized in a double-blind fashion to one of three doses of ZS-9 (5g, 10g or 15g) or placebo administered once-daily for 28 days (the randomized withdrawal period). The primary efficacy endpoint compared the mean serum K+ level of each ZS-9 treatment group to that of placebo over the interval between day 8 and day 28 of the randomized withdrawal period. Patients who completed the initial 28-day maintenance phase were eligible to enroll in an ongoing open label extension study, ZS004E.