SUNNYVALE, Calif. and SEATTLE, Sept. 10, 2012 /PRNewswire/ -- Sorbent Therapeutics, Inc. a biopharmaceutical company developing therapies for cardiovascular and renal diseases, today presented positive data from its randomized, double-blind Phase 2a clinical study of CLP1001. In the study of 111 heart failure patients with chronic kidney disease, CLP1001 demonstrated improvement in heart failure symptoms as compared to placebo.
Data from the Phase 2a study were presented by Barry M. Massie, M.D., Professor, University of California, San Francisco, President of the Heart Failure Society of America and member of Sorbent's Medical Advisory Board, during the Late-Breaking News Symposium at the Heart Failure Society of America 16th Annual Scientific Meeting in Seattle, Washington.
"The results of this clinical study suggest that CLP1001 may provide important benefits in addressing the signs and symptoms of heart failure," said Dr. Massie. "Specifically, the reduction of dyspnea and improved physical functionality among patients dosed with CLP1001 are associated with a better quality of life in heart failure patients already on standard guideline recommended medications."
"Heart failure symptoms are generally debilitating in spite of currently available therapies. The positive findings from our Phase 2a clinical trial indicate that CLP1001 may improve patient outcomes," said Howard C. Dittrich, M.D., F.A.C.C., Sorbent's Chief Medical Officer. "We look forward to working closely with the clinical community on additional clinical studies where we plan to measure the effects of CLP10001 on the physical functionality and overall quality of life of heart failure patients when administered in combination with standard medications for heart failure."
About the Phase 2a Study and Reported Clinical Results
The double-blind, randomized, parallel, placebo-controlled study examined the effect of CLP1001 over eight weeks in 111 heart failure patients with chronic kidney disease (CKD).
CLP1001-treated patients achieved significantly greater weight loss an accepted measurement of fluid retention as compared to placebo over the first two weeks of treatment. This trend continued through the end of the study. After eight weeks of treatment, a greater number of patients experienced marked or moderately improved breathing in the CLP1001 group, and the average distance walked in the 6-Minute Walk Test was larger in patients receiving CLP1001 versus the placebo population. CLP1001 improved functional heart capacity as assessed by the New York Heart Association (NYHA) classification by at least one class compared to the placebo group (48.8% vs. 17.4%; p=0.002). Similar results favoring the CLP1001 group were seen when examining quality of life.
These data were presented in a talk titled "A Phase 2, Randomized, Double-Blind, Multi-Center Placebo-Controlled Study of a Cross-Linked Polyelectrolyte (CLP vs. Placebo in Heart Failure Patients with Chronic Kidney Disease)".
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. Many people are not aware they have heart failure because the symptoms are often mistaken for signs of getting older. Heart failure affects approximately 5.8 million individuals in the United States annually. Demographic and clinical evidence strongly suggests that the prevalence of heart failure will increase throughout 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.
CLP1001 is a non-absorbable, super-absorbent cross-linked polyelectrolyte polymer that acts by removing sodium and fluid along 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. CLP1001 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