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Bausch Health Provides Update on RED-C Phase 3 Clinical Trials
Prnewswire· 2026-01-23 12:45
Core Insights - Bausch Health Companies Inc. announced the results of the global Phase 3 RED-C clinical program evaluating amorphous-rifaximin solid soluble dispersion (SSD) for the primary prevention of hepatic encephalopathy (HE) in adults with liver cirrhosis, which did not meet the primary endpoint despite being safe and well-tolerated [1][2] Group 1: Clinical Trial Details - The RED-C program included two global, randomized, double-blind, placebo-controlled Phase 3 trials with over 1,000 patients across 398 sites in 17 countries [3] - The trials aimed to evaluate rifaximin SSD for delaying the first episode of hepatic encephalopathy in adults with liver cirrhosis who had no prior HE episodes [3] Group 2: Company Commitment and Future Directions - The CEO of Bausch Health expressed disappointment in the trial results, highlighting the lack of approved treatments for these patients and indicating a review of the full dataset for potential new development opportunities [2] - Bausch Health remains committed to developing new treatments in hepatology and other therapeutic areas [2] Group 3: Context on Cirrhosis - Cirrhosis is a significant cause of end-stage liver disease in the US, ranking ninth as a cause of death according to the CDC [4] - The progression of cirrhosis is characterized by the development of hepatic encephalopathy, jaundice, clinically significant ascites, or variceal hemorrhage [4] Group 4: Company Overview - Bausch Health is a global, diversified pharmaceutical company focused on improving healthcare outcomes through a range of products in various therapeutic areas, including gastroenterology and hepatology [5] - The company aims to be a globally integrated healthcare provider, valued by patients, healthcare professionals, employees, and investors [5]