Intercept Pharmaceuticals Releases Additional Positive Results In Fatty Liver Disease Study

Shares of Intercept Pharmaceuticals (ICPT) are flat after the company reported additional positive results in the phase 2b NASH trial. NASH stands for non-alcoholic steatohepatitis and is a fatty liver disease not due too excessive alcohol use. This phase 2b trial known as "FLINT" enrolled 283 patients across eight centers across the United States. Each of these patients either received 25mg of OCA drug or a placebo compound and were evaluated with liver biopsies at 72-weeks. 

Intercept today reported results in patients with advanced NASH disease in a separate high-risk subgroup analysis. They used patients who were in a more advanced stage of the disease compared to the other patients in the study. Therefore today's highlighted results come from 160 patients in total - 84 patients who took OCA and 76 patients who took the placebo compound.

Final analysis showed that a significant percentage of patients had a complete resolution of their fibrosis. The OCA group showed a 15% improvement compared to placebo which only showed a 4% improvement. By evaluating the values of both the OCA vs. placebo, a p-value of p=0.006 means that OCA showed  statistical significance of greater improvement of fibrosis resolution against the placebo compound alone. 

In addition OCA showed improvements in cirrhosis prevention in stage 3 bridging fibrosis 6% OCA group versus 14% in the placebo group. In stage 2 fibrosis patients OCA was 0% versus 3% in the placebo group. In the instance of cirrhosis prevention the lower the percentage observed,  the better the results. These results were presented at the International Liver Congress 2015, the 50th Annual Meeting of the European Association for the study of the Liver -- EASL. 

Disclosure: no position any stocks mentioned

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