Bausch Health Companies Inc. has released the results of its global phase 3 red-c clinical program evaluating amorphous-rifaximin solid soluble dispersion (SSD) in adults with liver cirrhosis for the primary prevention of hepatic encephalopathy (HE). The company revealed that while the treatment was safe and well-tolerated, both clinical trials did not meet the primary endpoint.
These trials involved more than 1,000 patients across 398 sites in 17 countries. The data from these trials will be reviewed to determine potential new development opportunities. Bausch Health expressed its commitment to bringing new treatments to patients across hepatology and other therapeutic areas.
Cirrhosis is a major cause of end-stage liver disease in the US, with chronic liver disease and cirrhosis ranking ninth as a cause of death. The progression of cirrhosis is characterized by the development of hepatic encephalopathy (HE), jaundice, clinically significant ascites, or variceal hemorrhage.
Bausch Health Companies Inc. is a global, diversified pharmaceutical company that primarily develops, manufactures, and markets products in various areas including gastroenterology, hepatology, neuroscience, dermatology, dentistry, aesthetics, international pharmaceuticals, and eye health through its controlling interest in Bausch + Lomb Corporation.
The company's CEO, Thomas J. Appio, expressed disappointment in the results and emphasized the importance of the clinical research made possible by the participation of patients, families, investigators, and research teams.
The press release did not provide specific metrics or figures related to the clinical trial results or the company's financial performance. The market has reacted to these announcements by moving the company's shares -3.86% to a price of $6.98. If you want to know more, read the company's complete 8-K report here.
