Canadian pharmaceutical company Bausch Health Companies Inc (NYSE:BHC) (TSX:BHC) on Friday reported the results of the global Phase 3 RED-C clinical programme evaluating amorphous-rifaximin solid soluble dispersion (SSD) in adults with liver cirrhosis for the primary prevention of hepatic encephalopathy (HE).
Although the treatment was safe and well-tolerated, the two clinical trials did not meet the primary endpoint.
"We are disappointed in the results, as there is currently no approved treatment for these patients," said Thomas J. Appio, Bausch Health CEO. "We are currently reviewing the full dataset to determine potential new development opportunities."
The RED-C programme consists of two global, randomised, 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 HE in adults with liver cirrhosis who had no prior HE episodes.
Bausch Health said that it remains committed to bringing new treatments to patients across hepatology and other therapeutic areas.
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