Sorbent Therapeutics Initiates Phase 2b Clinical Trial of CLP-1001 for Treatment of Signs and Symptoms of Fluid Overload in Patients with Heart Failure
SUNNYVALE, Calif., April 11, 2013 /PRNewswire/ -- Sorbent Therapeutics, Inc., a biopharmaceutical company developing therapies for cardiovascular and renal diseases, today announced that patient dosing has commenced in its Phase 2b clinical trial of CLP-1001. This trial, known as STEPWISE (a randomized, double-blind, multi-center STudy comparing cross-linkEd Polyelectrolyte (CLP) WIth placebo in HF SubjEcts), is designed to evaluate the safety and efficacy of CLP-1001 in addressing signs and symptoms of fluid overload in patients with congestive heart failure (HF). CLP-1001 is a novel, non-absorbed oral polymer that acts by binding to and removing excess sodium and fluid in the GI tract independently of the kidneys.
"The objective of the STEPWISE trial is to further understand the magnitude of the effect of CLP-1001 on key measures and clinical endpoints of heart failure-induced congestion compared to current standard of care," said Howard C. Dittrich, M.D., F.A.C.C., Chief Medical Officer of Sorbent. "Fluid overload in heart failure patients contributes importantly to hospitalizations -- including re-hospitalizations -- slows in-patient recovery, and results in poor quality of life and physical limitations. Based on the positive clinical benefits observed in our Phase 2a clinical trial, we look forward to advancing CLP-1001 through late-stage registration studies."
STEPWISE is a double-blind, randomized, placebo-controlled, multicenter, study designed to evaluate CLP-1001 in patients with heart failure. Approximately 250 patients on stable, optimized, guideline heart failure therapy that have signs and symptoms of current fluid overload after a recent HF-related hospitalization will be randomized to receive 15 grams of CLP-1001 or placebo. The primary objective of this trial is to assess the change from baseline to eight weeks across several standard measures of patient quality of life and physical functioning, including 6-Minute Walk Test, body weight, Kansas City Cardiomyopathy Questionnaire, NT-pro BNP and time to first occurrence of HF hospitalization, decongestion therapy, or death. Secondary objectives for the Phase 2b study are to assess the safety and tolerability of CLP-1001 compared with placebo and to evaluate the effects after eight weeks of treatment on dyspnea (Visual Analog Scale), signs of fluid overload, blood pressure, diuretic dose and New York Heart Association (NYHA) classification.
In Sorbent's previous Phase 2a study, among 111 patients with heart failure, CLP-1001 demonstrated improvements of signs and symptoms of fluid retention, including greater weight loss, improved breathing and average distance walked in the 6-Minute Walk Test versus placebo.
About Heart Failure
Heart failure is a progressive condition in which the heart muscle becomes weakened after injury, most commonly caused by heart attack or high blood pressure, and gradually loses its ability to pump enough blood to supply the body's needs. Heart failure affects approximately 7.4 million individuals in the United States annually and the prevalence of heart failure is expected to significantly increase over the next decade. Despite available therapies, heart failure is the most common cause of hospitalizations in patients 65 years and older in the U.S.
CLP-1001 is a first-in-class, non-absorbable, superabsorbent cross-linked polyelectrolyte polymer that acts by removing sodium and fluid via the gastrointestinal tract. There is a significant need for agents other than diuretics to treat fluid overload associated with heart failure. Each year there are approximately one million hospitalizations plus re-hospitalizations in the US alone due to fluid overload. A majority of hospital admissions occur in patients already being treated with optimal medical therapy, including diuretics. CLP-1001 has the potential to provide additional sodium and fluid removal independent of the kidneys, making it an attractive alternative therapy.
Sorbent Therapeutics is a private biopharmaceutical company developing therapies for patients requiring targeted cation and fluid removal from the body. The company is focused on the development of non-absorbed polymeric drugs to satisfy unmet clinical needs in large cardiovascular and renal markets such as heart failure, end-stage renal disease, chronic kidney disease and hypertension. Sorbent is headquartered in Sunnyvale, California. For more information, visit www.sorbent.com.
SOURCE Sorbent Therapeutics
Posted: April 2013