Shares of Bausch Health (NYSE:BHC) dropped about 8% in early trading on Friday after the company disclosed unsuccessful late-stage trial results for an experimental treatment targeting hepatic encephalopathy.
The drugmaker said its global RED-C Phase 3 program, which studied amorphous-rifaximin solid soluble dispersion (SSD) in adults suffering from liver cirrhosis, did not achieve its primary endpoint. While the treatment demonstrated a favorable safety and tolerability profile, it failed to show sufficient efficacy in preventing first-time episodes of hepatic encephalopathy among cirrhosis patients.
“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,” said Thomas J. Appio, Chief Executive Officer of Bausch Health.
The RED-C initiative comprised two large-scale, randomized, double-blind, placebo-controlled Phase 3 studies enrolling more than 1,000 participants at 398 clinical sites across 17 countries. The trials focused on patients with liver cirrhosis who had not previously experienced hepatic encephalopathy.
According to data from the U.S. Centers for Disease Control and Prevention cited by the company, cirrhosis is the ninth leading cause of death in the United States. Hepatic encephalopathy is a severe neurological complication associated with advanced liver disease.
Despite the disappointing outcome, Bausch Health emphasized that it remains focused on advancing its research pipeline, including efforts to develop new therapies in hepatology and other treatment areas.