Coppell, Texas-based biopharmaceutical company ZS Pharma announced late-breaking data from the company’s Phase 3 trial of their novel treatment for hyperkalemia, which was presented at the 74th American Diabetes Association (ADA) Scientific Sessions, currently being held in San Francisco until June, 17th. Phase 3 of the ZS004 trial assessed the safety and efficacy of the drug ZS-9 in treating the life-threatening conditions distinguished by high levels of potassium in the blood.
Researcher David K. Packham, MD, Melbourne Renal Research Group at the Royal Melbourne Hospital, introduced the initial results of the trial and stated that ZS-9 has been able to achieve and maintain normal potassium levels in patients with diabetes.
The Phase 2 trial, which was concluded in June of 2013, had already demonstrated significant, rapid and sustainable reductions in potassium levels, as well as a safety profile comparable to placebo. During the multi center, randomized, double-blind, placebo-controlled trial, 753 patients, who were hyperkalemic at baseline, were administrated with either 5g or 10g doses of ZS-9, once daily, and the results revealed a reduction of potassium to normal levels within a 48 hour induction phase. Researchers were also able to control the normal range throughout the 12 day Extended Treatment Phase.
ZS Pharma presented preliminary results in an oral presentation at the National Kidney Foundation’s upcoming 2014 Spring Clinical Meetings, which took place in Las Vegas, Nevada on April 25th. The company is now planning to perform an additional long-term safety study, ZS005, beginning in the second quarter of 2014. ZS Pharma also expects to be able to finish the research and deliver the new drug to the U.S. Food and Drug Administration and to the European Medicines Agency next year.
Hyperkalemia is a metabolic condition, characterized by abnormally high concentrations of potassium in the blood caused by the inability of the kidneys to evacuate it or by the impairment of the mechanisms that transport potassium into the cells. The disease can provoke cardiac arrhythmia and sudden cardiac death, and is common within people who suffer from chronic kidney disease (CKD), diabetes and congestive heart failure (CHF), and who undergo a cardio-renal protective drug therapy, such as renin angiotensin aldosterone system (RAAS) inhibitors.
ZS-9 aims to treat the kidney, cardiovascular, and liver disorders. “With chronic medical conditions such as chronic kidney disease, diabetes and congestive heart failure on the rise, the incidence of this life-threatening condition is increasing, emphasizing the critical need for a new treatment that is rapid, predictable and safe,” stated Geoffrey A. Block, the clinical investigator for the trial and Director of Clinical Research at Denver Nephrology, in a previous presentation.