Bausch Health Companies announced the results of the global Phase 3 RED-C clinical program evaluating amorphous-rifaximin solid soluble dispersion (SSD) in adults with liver cirrhosis for the primary prevention of hepatic encephalopathy (HE). While safe and well-tolerated, both clinical trials did not meet the primary endpoint.
"We are disappointed in the results, as there is currently no approved treatment for these patients. We are currently reviewing the full dataset to determine potential new development opportunities," said Thomas J. Appio, Chief Executive Officer, Bausch Health. "We want to thank the patients, families, investigators, and research teams whose participation made this important clinical research possible."
About the RED-C Program
The RED-C program consists of two global, randomized, double-blind, placebo-controlled Phase 3 trials involving more than 1,000 patients across 398 sites in 17 countries. The clinical trials evaluated rifaximin SSD for the delay of the first episode of hepatic encephalopathy (HE) in adults with liver cirrhosis who had no prior HE episodes.
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