- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Liver Drug Meets Primary Endpoint in Late-Stage Trial
Obeticholic acid treats nonalcoholic fatty liver disease (January 9)
A pivotal trial of obeticholic acid (OCA) for the treatment of nonalcoholic steatohepatitis (NASH) has been stopped early for efficacy based on a planned interim analysis showing that the primary endpoint of the trial had been met.
The Farnesoid X Receptor Ligand Obeticholic Acid In Nonalcoholic Steatohepatitis Treatment (FLINT) trial was a double-blind, placebo-controlled study assessing the safety and efficacy of a 25-mg oral dose of OCA administered daily in adults with biopsy-proven NASH over a 72-week period.
The decision to stop the FLINT study was based on the recommendation of a data safety monitoring board, which reviewed liver biopsy data from before treatment and at the end of the treatment period in approximately half of the 283 patients. This analysis demonstrated that treatment with OCA resulted in a statistically significant improvement (P = 0.0024 on an intention-to-treat basis) in the primary histological endpoint, defined as a decrease in the Nonalcoholic Fatty Liver Disease Activity Score (NAS) of at least two points with no worsening of fibrosis, compared with placebo.
NASH is a serious chronic liver disease caused by excessive fat accumulation in the liver that, for reasons that are not completely understood, induces chronic inflammation, which leads to progressive fibrosis that can result in cirrhosis, eventual liver failure, and death. No drugs are currently approved to treat the disease.
Source: Intercept Pharmaceuticals; January 9, 2014.