Bausch Health Phase 3 RED-C Trials in 1,000+ Patients Miss Primary Endpoint
Bausch Health’s global Phase 3 RED-C program of amorphous-rifaximin dispersion in over 1,000 cirrhosis patients failed both trials to delay first hepatic encephalopathy episodes. The treatment was safe and well-tolerated, and the company is reviewing full data for new development opportunities.
1. Trial Design and Outcomes
The RED-C program comprised two randomized, double-blind, placebo-controlled Phase 3 trials across 17 countries, enrolling more than 1,000 adults with liver cirrhosis. Both studies evaluated amorphous-rifaximin solid soluble dispersion for primary prevention of hepatic encephalopathy but failed to meet the endpoint of delaying first encephalopathy episodes.
2. Safety and Tolerability
Despite missing efficacy targets, the treatment demonstrated a favorable safety profile and was well-tolerated across all 398 trial sites. No new safety signals emerged, reinforcing the compound’s tolerability in the cirrhosis patient population.
3. Strategic Next Steps
Bausch Health is conducting a comprehensive review of the RED-C dataset to identify potential biomarkers or subpopulations for future studies. The company remains committed to its hepatology pipeline and will assess resource allocation for alternative development paths.