US-based pharmaceutical firm ZS Pharma has released positive top-line results from the acute phase of the randomised, double-blind, Phase III clinical study of ZS-9 called ‘ZS-003’ for the treatment of hyperkalemia, a life-threatening metabolic condition that can lead to cardiac arrhythmia and sudden death.

A total of 753 patients with hyperkalemia (potassium levels 5-6.5 mEq/L), including patients with chronic kidney disease (CKD), heart failure, diabetes, and those on renin angiotensin aldosterone system (RAAS) inhibitor therapy were enrolled in the trial.

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In the acute phase of the trial, patients were given one of four doses of ZS-9 (1.25g, 2.5g, 5g or 10g) or placebo, administered three times daily for the initial 48 hours.

The safety and efficacy results of the acute phase demonstrated that the Phase III trial ZS-003 met its primary endpoint and showed a rapid, safe and effective reduction of potassium in hyperkalemic patients within 48 hours, which was the same primary endpoint used in the Phase II trial ZS-002.

"There is a critical need for a new treatment for patients with hyperkalemia, including those with chronic kidney disease, diabetes, heart failure and those who should be on cardio-renal protective treatment such as ACEs and ARBs."

Results of both of the clinical studies support the safety and efficacy of ZS-9 in treating hyperkalemia, regardless of underlying cause.

The acute phase was followed by a subacute phase, in which normalised patients were given once-daily doses of ZS-9 (1.25g, 2.5g, 5g or 10g) or placebo for 12 days and its secondary endpoint was the rate of change in serum K+ during the 12-day dosing period.

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Denver Nephrology director of clinical research and clinical investigator in the ZS-003 study Geoff Block said: "There is a critical need for a new treatment for patients with hyperkalemia, including those with chronic kidney disease, diabetes, heart failure and those who should be on cardio-renal protective treatment such as ACEs and ARBs."

The company expects to release additional results from the ZS-003 trial, including the subacute phase, in the coming months.

About 90 patients with Stage 3 CKD and mild to moderate hyperkalemia were enrolled in the double-blind, placebo-controlled Phase II trial ZS-002 that assessed the safety and efficacy of ZS-9 in treating hyperkalemia in patients with CKD.

ZS Pharma plans to initiate an additional Phase III study, the ZS-004 trial, in early 2014 under its ZS-9 clinical program which is designed to investigate the treatment of acute, subacute and chronic hyperkalemia.

The ZS-004 study, a randomised, double-blind, placebo-controlled trial, is designed to confirm, using a month-long dosing period, the optimal dose of ZS-9 for extended treatment.