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SOURCE Sorbent Therapeutics, Inc.
Completes Enrollment in Phase 2b Clinical Trial of CLP-1001 for Heart Failure
SUNNYVALE, Calif., May 15, 2014 /PRNewswire/ -- Sorbent Therapeutics, Inc., a biopharmaceutical company developing therapies for cardiovascular and renal diseases, today announced the closing a $6.5 million tranche in a $15 million Series D financing. Existing investors CMEA Capital, ARCH Venture Partners, Sofinnova Ventures, AgeChem and Novartis Venture Funds participated in the round.
Sorbent also announced the completion of enrollment of 275 patients with heart failure in the company's Phase 2b STEPWISE clinical trial of CLP-1001. The Phase 2b randomized, double-blind, multi-center STEPWISE trial is intended to evaluate the safety, tolerability and efficacy of CLP-1001 therapy in addressing the signs and symptoms of fluid overload in heart failure patients. Sorbent expects to announce topline results from the STEPWISE clinical study during the third quarter of 2014. Proceeds from the financing will be used to support continued development of CLP-1001 and general corporate operations.
"CLP-1001 has shown great promise in alleviating the negative impact of fluid overload in heart failure patients as demonstrated in our prior Phase 2a clinical trial. We look forward to reporting data from the STEPWISE trial later this year," said Detlef Albrecht, M.D., Sorbent's President and Chief Executive Officer. "I would like to thank our existing investors for their continued support. This new round of funding and the progress in our lead CLP program take us several steps closer to achieving our goal of bringing a new therapeutic option to advanced congestive heart failure patients."
"More than 7 million people in the U.S. suffer from heart failure, and unfortunately the prognosis is typically very poor in spite of a number of treatments that provide some benefit," said Howard C. Dittrich, M.D., FACC, Sorbent's Chief Medical Officer. "CLP-1001 may provide a first-in-class therapy intended to reduce excess sodium and water retention in patients with heart failure, thereby improving symptoms and quality of life. CLP-1001 demonstrated clinically meaningful improvements across many well-established measurements of heart failure in prior clinical studies, and we look forward to duplicating these results in our Phase 2b STEPWISE trial."
About CLP-1001 in Heart Failure
CLP-1001 is a cross-linked polyelectrolyte polymer intended to selectively bind to and remove excess water and sodium in the GI tract. As the fastest-growing cardiac disease in the U.S., heart failure results in more than one million hospitalizations each year. Fluid overload is estimated to be involved in 80% of heart failure hospitalizations due to the additional pressure that excess water and sodium place on the heart and kidneys. Sorbent completed a Phase 2a study with CLP-1001 in 100 patients that demonstrated favorable effects on many of the signs and symptoms of heart failure in patients with advanced symptomatic heart failure and chronic kidney disease.
About the STEPWISE Clinical Trial
The STEPWISE (study comparing cross-linked polyelectrolyte (CLP-1001) with placebo in heart failure subjects) Phase 2b clinical trial enrolled patients who are on stable, optimized, guideline heart failure therapy and that continue to show signs of fluid overload, including a heart failure-related hospitalization or decongestion therapy in the not too distant past. Patients are randomized to CLP-1001 or placebo for treatment duration of eight weeks with a four-week follow up. The primary endpoint is a composite of change from baseline to eight weeks for six-minute walk test, body weight, Kansas City Cardiomyopathy Questionnaire (KCCQ), N-terminal pro brain natriuretic peptide (NT-pro BNP) and time to first occurrence of a related hospitalization, unplanned decongestion therapy, or death. Each of the measurements that comprise the primary endpoint will be measured individually in addition to the secondary endpoints of dyspnea, signs of fluid overload, blood pressure, diuretic dose and New York Heart Association (NYHA) classification.
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, chronic kidney disease and hypertension. Sorbent is headquartered in Sunnyvale, California. For more information, visit www.sorbent.com.
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