COPPELL, TX, USA I March 25, 2014 I ZS Pharma, a specialty pharmaceutical company developing novel treatments for kidney, cardiovascular and liver disorders, today announced that it has begun enrolling patients in ZS004, its second Phase 3 clinical trial of ZS-9, a novel investigational treatment for hyperkalemia. This randomized, double-blind, placebo-controlled study is designed to confirm, over a longer treatment period, the positive results previously reported for ZS003, a Phase 3 trial in which a once-daily dose of ZS-9 (5g or 10g) maintained potassium levels within the normal range with safety and tolerability similar to placebo.
ZS004, a global multicenter, multi-dose, prospective clinical trial, is enrolling patients with hyperkalemia (potassium levels >5 mEq/L), including patients with chronic kidney disease (CKD), heart failure, diabetes, and those on renin angiotensin aldosterone system (RAAS) inhibitor therapy. In the open-label induction phase of the trial, approximately 275 patients with hyperkalemia will receive 10g of ZS-9 administered three times daily for 48 hours. Patients who achieve normokalemia (potassium levels between 3.5 and 5 mEq/L) are eligible to be randomized in a double-blind fashion to one of three doses of ZS-9 (5g, 10g or 15g) or placebo administered once-daily for 28 days. The primary efficacy endpoint of the ZS004 trial is the mean serum potassium level of each ZS-9 treatment group compared with that of placebo.
In conjunction with ZS004, ZS Pharma will also be conducting ZS004E, an extension study that will generate longer-term open-label safety, tolerability and efficacy data in patients who participated in ZS004. In ZS004E, patients will receive up to an additional 60 days of treatment, resulting in a combined potential of 90 days of treatment with ZS-9 over the course of ZS004 and ZS004E.
About ZS-9’s Clinical Development Program
The ZS-9 clinical program is designed to investigate the treatment of acute and chronic 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. In addition to ZS004, the Company plans to initiate an additional long-term safety study in 2014 and plans to file a New Drug Application with the United States Food and Drug Administration and a Marketing Authorization Application with the European Medicines Agency in the first half of 2015.
About Hyperkalemia
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.
SOURCE: ZS Pharma
Post Views: 73
COPPELL, TX, USA I March 25, 2014 I ZS Pharma, a specialty pharmaceutical company developing novel treatments for kidney, cardiovascular and liver disorders, today announced that it has begun enrolling patients in ZS004, its second Phase 3 clinical trial of ZS-9, a novel investigational treatment for hyperkalemia. This randomized, double-blind, placebo-controlled study is designed to confirm, over a longer treatment period, the positive results previously reported for ZS003, a Phase 3 trial in which a once-daily dose of ZS-9 (5g or 10g) maintained potassium levels within the normal range with safety and tolerability similar to placebo.
ZS004, a global multicenter, multi-dose, prospective clinical trial, is enrolling patients with hyperkalemia (potassium levels >5 mEq/L), including patients with chronic kidney disease (CKD), heart failure, diabetes, and those on renin angiotensin aldosterone system (RAAS) inhibitor therapy. In the open-label induction phase of the trial, approximately 275 patients with hyperkalemia will receive 10g of ZS-9 administered three times daily for 48 hours. Patients who achieve normokalemia (potassium levels between 3.5 and 5 mEq/L) are eligible to be randomized in a double-blind fashion to one of three doses of ZS-9 (5g, 10g or 15g) or placebo administered once-daily for 28 days. The primary efficacy endpoint of the ZS004 trial is the mean serum potassium level of each ZS-9 treatment group compared with that of placebo.
In conjunction with ZS004, ZS Pharma will also be conducting ZS004E, an extension study that will generate longer-term open-label safety, tolerability and efficacy data in patients who participated in ZS004. In ZS004E, patients will receive up to an additional 60 days of treatment, resulting in a combined potential of 90 days of treatment with ZS-9 over the course of ZS004 and ZS004E.
About ZS-9’s Clinical Development Program
The ZS-9 clinical program is designed to investigate the treatment of acute and chronic 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. In addition to ZS004, the Company plans to initiate an additional long-term safety study in 2014 and plans to file a New Drug Application with the United States Food and Drug Administration and a Marketing Authorization Application with the European Medicines Agency in the first half of 2015.
About Hyperkalemia
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.
SOURCE: ZS Pharma
Post Views: 73
