ZS Pharma has announced the completion of patient enrollment for the evaluation of efficacy and safety of its drug candidate ZS-9 in the phase 3 clinical trials (ZS-003). ZS Pharma specializes in the development of highly advanced novel drugs for the management and treatment of a variety of disorders involving the kidneys, liver, and cardiovascular system.
ZS-9 has been developed for the therapeutic management of hyperkalemia – a-life threatening sequelae of systemic disorders like diabetes, the side-effects of certain drugs (especially those that monitor the excretion of electrolytes from the kidney like aldosterone, ACE and ARBs), heart failure, chronic renal impairment, and other ailments. Hyperkalemia is marked by high serum concentration of potassium in the blood that may significantly interfere with normal cardiac functioning, and may culminate in death due to heart failure.
Executive chairman of ZS Pharma, Dr. Robert Alexander explained: “With enrollment in our Phase 3 trial now complete, we are in a position to have top-line results by year end and to advance the clinical development of ZS-9.”
The aim of the ZS-003 pivotal trial is to analyze the effectiveness of ZS-9 in reducing potassium levels efficiently from the blood without endangering the life of the patient within a total duration of 48 hours. The trial is also associated with an additional sub- acute phase consisting of a 12-day period, during which time the study participants will be tested with an extended dose of the drug.
Details of the Phase 3 Clinical trial:
The ZS-9 clinical program seeks to devise and design effective therapeutic options for the acute, sub-acute and long term management of hyperkalemia in patients. The phase 3 clinical trial will be a double blind, randomized pivotal study (ZS-003) in which 750 patients have already been enrolled. The inclusion criteria were set at evaluating hyperkalemic patients (with serum potassium concentration within the range of 5 – 6.5 mEq/ L) in the setting of chronic medical scenarios like RAAS inhibitor therapy, heart failure, renal failure, diabetes and other metabolic disorders.
During the clinical trial, each patient will receive either a placebo or ZS-9 (which is further grouped into 4 categories, based on the dosage — @ 1.25 g/ 2.5 g/ 5 g or 10 g) via random selection of study participants. The drugs will be introduced three times daily for the first 48 hours (in the acute phase), and will be followed by a sub-acute phase of 12 days, during which all the normalized patients will receive once daily dose of ZS- 9 (in either of the four listed doses) or placebo.
– The primary end-point of the study: To observe the rate of change in the serum concentration of potassium during acute phase (or first 48 hours of the trial).
– Primary end-point of Sub-acute phase: To observe the rate of serum potassium change from the first day of sub-acute phase (Day 3 of trial) to the rest of the trial (12 day period).
The company is also working on initiating a placebo-controlled, double blind and randomized ZS-004 (an additional phase 3 trial) in order to determine a safe and effective therapeutic dosage of ZS-9 for the management of hyperkalemia. ZS-004 will be initiated in early 2014.
Hyperkalemia is a medical emergency that is characterized by serum potassium concentration of more than 5 mEq/L and is reported quite frequently in medical practice (especially in patients who have chronic impairment of renal and hepatic system and in those who are receiving treatment for systemic and metabolic disorders like diabetes, hypertension, ischemic heart disease and other ailments. Hyperkalemia can lead to arrhythmia, cardiac failure or sudden cardiac death.