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ARTICLE | Clinical News

ZS Pharma compound meets endpoint in Phase III hyperkalemia trial

November 12, 2013 12:44 AM UTC

ZS Pharma Inc. (Coppell, Texas) said thrice-daily oral ZS-9 met the primary endpoint of reducing serum potassium levels from baseline to 48 hours in the Phase III ZS-003 trial to treat hyperkalemia. Specifically, 2.5, 5 and 10 g doses of oral ZS-9 each reduced serum potassium levels from baseline to 48 hours (acute phase) vs. placebo (p=0.0009, p<0.0001 and p<0.0001, respectively). The 1.25 g dose of ZS-9 missed the endpoint. The double-blind, U.S. and Australian trial enrolled 753 patients with mild to moderate hyperkalemia, defined as potassium levels of 5-6.5 mEq/L. Data were presented at the American Society of Nephrology meeting in Atlanta.

The ZS-003 trial also includes a subacute phase in which dosing of ZS-9 will be reduced to once daily in normalized patients (potassium levels of 3.5-4.9 mEq/L) for 12 days to evaluate whether ZS-9 can maintain potassium levels in the normal range. ZS Pharma expects to report additional data from the trial, including secondary endpoint data measuring the change in serum potassium levels in the subacute phase, "in the coming months." ...