Bausch Health Provides Update on RED-C Phase 3 Clinical Trials

Executive Summary

• Bausch Health announced that both global Phase 3 RED‑C trials of amorphous‑rifaximin solid soluble dispersion (SSD) in adults with liver cirrhosis failed to meet the primary endpoint for preventing hepatic encephalopathy.
• The trials were safe and well‑tolerated but did not demonstrate efficacy, representing a material negative development for the company’s hepatology pipeline.
• Management is reviewing the full dataset to assess alternative development opportunities.

Key Details

• Program Scope: Two randomized, double‑blind, placebo‑controlled Phase 3 studies enrolling >1,000 patients across 398 sites in 17 countries.
• Indication: Primary prevention of first hepatic encephalopathy (HE) episode in cirrhotic adults with no prior HE events.
• Outcome: Neither trial achieved the primary efficacy endpoint; safety profile remained acceptable.
• CEO Statement: “We are disappointed in the results… we are currently reviewing the full dataset to determine potential new development opportunities.” – Thomas J. Appio, CEO.
• Future Plans: Company remains committed to hepatology research and will explore alternative pathways for the investigational product.

Notable Quotes

“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,” – Thomas J. Appio, Chief Executive Officer.