Bausch Health Companies (NYSE:BHC) today announced results from its global Phase 3 RED-C clinical program evaluating amorphous-rifaximin SSD for the primary prevention of hepatic encephalopathy (HE) in adults with liver cirrhosis.
The trials were safe and well-tolerated but did not meet the primary endpoint.
Management stated that the company is currently reviewing the full dataset to assess potential new development opportunities for amorphous-rifaximin SSD in this indication or related areas. Bausch Health expressed appreciation to the patients, investigators, and research teams who participated in the program and reaffirmed its ongoing commitment to advancing treatments in hepatology and other key therapeutic areas.
Hepatic encephalopathy is a serious complication of advanced liver disease characterized by cognitive impairment and neurological symptoms.
Rifaximin, in its standard crystalline form, is already approved for reducing the risk of overt HE recurrence, and the amorphous solid dispersion (SSD) formulation was developed to potentially improve bioavailability and efficacy for primary prevention.
The company will provide further updates on the RED-C data analysis, strategic implications, and any revised development plans as the review progresses.
The announcement reflects a setback in Bausch Health’s hepatology pipeline but aligns with the company’s broader focus on evaluating clinical outcomes to inform future investment decisions in liver disease therapies.