COPPELL, Texas--(BUSINESS WIRE)--ZS Pharma, a specialty pharmaceutical company developing novel treatments for kidney, cardiovascular, and liver disorders, today announced that it has completed a $55 million Series D financing. The investor syndicate was led by Novo A/S and included new investors RA Capital, Adage Capital, Sofinnova Ventures, and one other top-tier institutional investor. The financing also included existing investors Alta Partners, Devon Park Bioventures, 3x5 Special Opportunity Fund, Salem Partners and RiverVest. Proceeds will be used to advance development of ZS-9, the Company’s lead product candidate for the treatment of hyperkalemia, through its New Drug Application (NDA) and Marketing Authorization Application (MAA) submissions in early 2015.
About ZS-9’s Clinical Development Program
The ZS-9 clinical program is designed to investigate both the acute and extended treatment of hyperkalemia, regardless of underlying cause. ZS Pharma recently completed a 753 patient Phase 3 study, which showed that ZS-9 rapidly reduced serum potassium in hyperkalemic patients to normal levels within 48 hours and maintained potassium in the normal range with once-daily dosing. In addition, the study provided evidence that ZS-9 is safe and well-tolerated with an adverse event profile similar to placebo. The Company will initiate two additional studies in 2014 and plans to file an NDA with the United States Food and Drug Administration (FDA) and an MAA with the European Medicines Agency (EMA) in early 2015.
Hyperkalemia, or higher than normal potassium levels (typically defined as a serum potassium level >5 mEq/L), is a life-threatening metabolic condition that can lead to cardiac arrhythmia and sudden cardiac death. Hyperkalemia is characterized by abnormally high concentrations of potassium in the blood resulting from the inability of the kidneys to excrete potassium, impairment of mechanisms that transport potassium into cells, or a combination of both factors. The causes of hyperkalemia vary but the most common are chronic kidney disease (CKD), diabetes, congestive heart failure (CHF), hypertension and side effects from cardio-renal protective drug therapy, such as renin angiotensin aldosterone system (RAAS) inhibitors.
About ZS Pharma
ZS Pharma is a privately held specialty pharmaceutical company based in Coppell, Texas. ZS Pharma’s lead therapeutic candidate, ZS-9, is a novel investigational treatment for hyperkalemia that is being evaluated in late-stage clinical trials to demonstrate its ability to safely and effectively remove excess potassium from the blood and maintain normal potassium levels. ZS Pharma is also pursuing the discovery of additional drug candidates that utilize its novel selective ion-trap technology for the treatment of kidney and liver diseases. Additional information is available at www.zspharma.com.