Bausch Health Companies Inc. announced topline results from its global phase 3 RED-C clinical program evaluating amorphous-rifaximin solid soluble dispersion (SSD) for the primary prevention of hepatic encephalopathy (HE) in adults with liver cirrhosis.
Although rifaximin SSD was safe and well-tolerated, both phase 3 trials failed to meet the primary endpoint.
What the RED-C program studied?
The RED-C program consists of two large, global, randomized, double-blind, placebo-controlled phase 3 trials.
Key features:
- More than 1,000 patients
- 398 sites across 17 countries
- Adults with liver cirrhosis
- No prior episodes of hepatic encephalopathy
- Evaluated rifaximin SSD for delaying the first HE episode
Company response
Thomas J. Appio, CEO, Bausch Health, said:
We are disappointed in the results, as there is currently no approved treatment for these patients. We are reviewing the full dataset to determine potential new development opportunities.
He also thanked patients, families, investigators, and research teams who participated in the studies.
Why this remains an unmet need?
Cirrhosis is a leading cause of end-stage liver disease in the United States. According to CDC data (October 25, 2024):
- Chronic liver disease and cirrhosis rank ninth among causes of death
Progression of cirrhosis is often marked by:
- Hepatic encephalopathy
- Jaundice
- Clinically significant ascites
- Variceal haemorrhage
Currently, no therapies are approved for primary prevention of HE in cirrhosis patients without prior episodes.
What’s next?
Bausch Health says it remains committed to:
- Hepatology research
- Identifying potential new development paths based on the RED-C dataset
- Advancing treatments across multiple therapeutic areas
Big picture
These results underscore how challenging it is to prevent first-onset hepatic encephalopathy. Even well-established molecules like rifaximin, when reformulated, face high clinical risk in this setting.
Future success may depend on:
- Better patient stratification
- Biomarker-driven enrollment
- Combination strategies targeting gut microbiota, inflammation, and ammonia metabolism
