Bausch Health results from Phase 3 RED-C program did not meet primary endpoint

Bausch Health (BHC) Companies announced the results of the global Phase 3 RED-C clinical program evaluating amorphous-rifaximin solid soluble dispersion, or SSD, in adults with liver cirrhosis for the primary prevention of hepatic encephalopathy, or HE. While safe and well-tolerated, both clinical trials did not meet the primary endpoint. 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 HE in adults with liver cirrhosis who had no prior HE episodes. Cirrhosis is a major cause of end-stage liver disease in the US.