Bausch Health's RED-C trials fail to meet end point

Executive Summary

• Bausch Health announced that both global Phase 3 RED-C clinical trials evaluating amorphous-rifaximin SSD for the primary prevention of hepatic encephalopathy in adults with liver cirrhosis failed to meet their primary endpoints.
• The trials demonstrated a safe and well-tolerated safety profile, but the company is reviewing the full dataset to explore potential new development opportunities.
• The RED-C program consisted of two randomized, double-blind, placebo-controlled trials involving over 1,000 patients across 398 sites in 17 countries.

Key Details

• Drug/Intervention: Amorphous-rifaximin solid soluble dispersion (SSD)
• Indication: Primary prevention of hepatic encephalopathy (HE) in adults with liver cirrhosis who have no prior HE episodes
• Trial Outcome: Both Phase 3 trials did not meet the primary endpoint
• Safety Profile: Safe and well tolerated
• Trial Design: Two global, randomized, double-blind, placebo-controlled Phase 3 trials
• Patient Enrollment: >1,000 patients
• Geographic Scope: 398 clinical sites across 17 countries
• Disease Context: Cirrhosis is a major cause of end-stage liver disease in the US; chronic liver disease and cirrhosis rank 9th as a cause of death (per Oct 25, 2024 CDC data).

Notable Quotes

• Thomas J. Appio, CEO: "We are disappointed in the results as there is currently no approved treatment for these patients. We are currently reviewing the full data set to determine potential new development opportunities."