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Bausch Health and Salix to Present at the American Association for the Study of Liver Disease (AASLD) the RED-C Phase 3 Study Design for a New Investigational Product Designed to Address Serious Complications of Cirrhosis
Next generation product may increase gastrointestinal luminal concentration while limiting system...
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[{"type":"text","content":"Bausch Health and Salix to Present at the American Association for the Study of Liver Disease (AASLD) the RED-C Phase 3 Study Design for a New Investigational Product Designed to Address Serious Complications of CirrhosisNext generation product may increase gastrointestinal luminal concentration while limiting system exposure LAVAL, QC / ACCESSWIRE / November 18, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals (\"Salix\"), today announced the first look at its late-stage RED-C clinical trial program which will be presented at the American Association for the Study of Liver Disease (AASLD), The Liver Meeting® in San Diego, CA. This clinical program was designed to assess the efficacy of a next generation therapeutic, a soluble solid dispersion (SSD) immediate-release rifaximin product, to delay onset of first overt hepatic encephalopathy (OHE) hospitalization. There are no medications globally approved for the primary prophylaxis and delay in decompensation to first episode of OHE in cirrhosis. Another objective of this study is to assess the effects of treatment with this next generation therapeutic on the time to the onset of significant clinical events, including all-cause hospitalization rates, first occurrence of OHE event requiring hospitalization, and all-cause mortality.The RED-C program is evaluating a next generation therapeutic designed to enhance the gastrointestinal luminal solubility of a unique form of rifaximin in order to preserve epithelial function, limit bacterial translocation to the bloodstream and liver, and reduce proinflammatory cytokine production. The RED-C program includes two global Phase 3, randomized, double-blind, placebo-controlled studies conducted in over 1,000 patients, over 398 study sites, and across 17 countries. Patient enrollment on both trials is now complete with efficacy and safety results to be announced at future congresses.\"The RED-C program underscores our dedication to exploring and identifying new treatments for individuals with cirrhosis,\" stated Aimee Lenar, Executive Vice President of US Pharma at Bausch Health. \"Considering the significant unmet need for cirrhotic patients, the RED-C phase 3 trials have been rigorously designed to assess a potential new option to delay the onset of the first overt he...