Pharma powerhouse Bausch Health Companies has announced that its global Phase 3 RED-C clinical trials testing amorphous-rifaximin solid soluble dispersion (SSD) for the primary prevention of hepatic encephalopathy (HE) in adults with liver cirrhosis did not meet their primary endpoints.

 

The trials, which enrolled over 1,000 patients across 398 sites in 17 countries, showed that the drug was safe and well-tolerated—but ultimately failed to deliver the hoped-for clinical results.

 

“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 of Bausch Health. “We want to thank the patients, families, investigators, and research teams whose participation made this important clinical research possible.”

 

Bausch Health emphasized its continued commitment to developing new treatments for liver disease and other therapeutic areas, even in the face of setbacks.

 

Cirrhosis, a leading cause of end-stage liver disease in the U.S., can progress to serious complications including hepatic encephalopathy, jaundice, ascites, and variceal hemorrhage. According to the CDC, chronic liver disease and cirrhosis rank ninth among causes of death in the US.

 

The RED-C program represents one of the largest global efforts to prevent the first episode of HE in patients with cirrhosis who have not previously experienced the condition. Despite the disappointing outcomes, Bausch Health stressed the importance of the data in guiding future research.