Sorbent begins CLP-1001 Phase 2b trial in heart failure patients

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 randomize 250 patients on stable, optimized, guideline heart failure therapy with 15 grams of CLP-1001 or placebo.

Sorbent chief medical officer Howard Dittrich said STEPWISE trial aims to measure the magnitude 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 hospitalizations — including re-hospitalizations — slows in-patient recovery, and results in poor quality of life and physical limitations," Dittrich added.

"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."

Evaluation of the change from baseline to eight weeks across several standard measures of patient quality of life and physical functioning, such as 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 is 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, signs of fluid overload, blood pressure, diuretic dose and New York Heart Association classification.