Biopharmaceutical company Sorbent Therapeutics has initiated a Phase IIb clinical trial of CLP-1001 to treat the signs and symptoms of fluid overload in heart failure patients.
The non-absorbed oral polymer, CLP-1001, binds to and removes excess sodium and fluid in the GI tract independently of the kidneys.
The randomised, double-blind, multi-centre study comparing cross-linked polyelectrolyte (CLP) with placebo in HF subjects (STEPWISE) trial will assess the safety and efficacy of CLP-1001.
Sorbent chief medical officer Dr Howard Dittrich said STEPWISE aims to measure the scale of the effect of CLP-1001 on key measures and clinical endpoints of heart failure-induced congestion, compared to existing care.
"Fluid overload in heart failure patients contributes importantly to hospitalisations – including re-hospitalisations – slows in-patient recovery, and results in poor quality of life and physical limitations," Dittrich said.
"Based on the positive clinical benefits observed in our Phase IIa clinical trial, we look forward to advancing CLP-1001 through late-stage registration studies."
The STEPWISE study is expected to randomise 250 patients on stable, optimised, guideline heart failure therapy with 15g of CLP-1001 or placebo.
Evaluation of the change from baseline to eight weeks across several standard measures of patient quality of life and physical functioning, such as the 6-Minute Walk Test, body weight, Kansas City Cardiomyopathy Questionnaire, NT-pro BNP and time to first occurrence of HF hospitalisation, decongestion therapy or death is the primary objective of the trial.
Secondary objectives include the evaluation of the safety and tolerability of CLP-1001 compared with placebo and 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.