New Phase III data on ZS 9 for Hyperkalemia - ZS Pharma

ZS Pharma has announced new sub-group analysis data from a pivotal Phase III trial of ZS 9 in treating patients with Hyperkalemia. The ZS003 sub-group analysis, which was pre-specified, specifically looked at patients taking renin-angiotensin-aldosterone system inhibitor (RAASi) drug therapies, including angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs) and aldosterone blockers. Results demonstrated that both the 5g and 10g doses of ZS 9, administered once daily, controlled potassium at normal levels in these hyperkalemic patients. Data was presented at the 2014 American Society of Hypertension (ASH) Annual Scientific Meeting.

In 2014, ZS Pharma initiated ZS004, its second Phase III clinical trial of ZS 9. ZS004 is a randomized, double-blind, placebo-controlled study designed to confirm, over a longer treatment period, the positive results previously reported for ZS003. In addition to ZS004, the Company plans to initiate an additional long-term safety study, ZS005, in the second quarter of 2014, and plans to file a New Drug Application with the FDA and a Marketing Authorization Application with the European Medicines Agency in the first half of 2015.