Reuters Health Information (2014-01-09): Drug for nonalcoholic steatosis meets main goal in study
Drug & Device Development
Drug for nonalcoholic steatosis meets main goal in study
Last Updated: 2014-01-09 19:33:57 -0500 (Reuters Health)
By Reuters Staff
(Reuters) - Intercept Pharmaceuticals Inc said an analysis by an independent safety committee showed that its liver disease drug, obeticholic acid, met the main goal of a mid-stage trial in patients with non-alcoholic steatohepatitis.
The success paves the way for it to become the first approved treatment for the chronic condition.
The company said it stopped the trial after the committee found that the drug showed statistically significant improvement in patients, compared with a placebo.
Intercept said the committee made the recommendation after reviewing liver biopsy data from about half of the 283 patients enrolled in the trial.
The company is also testing obeticholic acid in mid-stage studies to treat bile acid diarrhea and portal hypertension.
The drug's structure is similar to that of a naturally occurring human bile acid.