Marzo 2018
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Intercept Liver Drug Is A Game Changer For The Biotech Industry

Fatty Liver Disease: Genes Affect Risk

academic hepatology centers comprising the NIDDK's NASH clinical research network (CRN). THE NEWS Data Safety Monitoring Board (DSMB) has ordered stopping the trial with the drug after reviewing liver biopsy data from before and at the end of the treatment period in approximately half of the 283 randomized patients, The DSMB analysis demonstrated that OCA resulted in a highly statistically significant improvement (p=0.0024 on an intention-to-treat [ITT] basis) in the primary histological endpoint, defined as a decrease in the NAFLD Activity Score (NAS) of at least two points with no worsening of fibrosis, as compared to placebo. The patients who had not yet completed the trial and therefore did not have a second biopsy were treated as non-responders in the ITT analysis. The pre-defined threshold of statistical significance for stopping FLINT was p < 0.0031. Intercept discussed NASH and the FLINT trial in a conference call on January 9th. The replay of the call is now available on the Intercept website here for two weeks. Intercept's collaborator Dainippon Sumitomo Pharma is currently conducting a NASH trial in Japan. This trial is evaluating the safety and efficacy of a once-daily dose of OCA as compared to placebo, with a targeted enrollment of 200 patients. Enrollment is projected to be completed by the end of January 2014 with top-line results expected by the end of 2015. Observations The stock started an unprecedented rally a few minutes following the announcement of the news.

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The team detected more than 12,000 gene variants. In the end, only one gene was linked to liver fat: a gene with unknown function called PNPLA3. A variant version of this gene was strongly linked to fatty liver. The variant was seen in 49% of Hispanic-Americans, 23% of European-Americans, and 17% of African-Americans in the study. Analysis showed that the gene explains 72% of the ancestry-related differences in liver fat. Interestingly, this gene variant was also linked to liver inflammation -- possibly the next step on the way to serious disease.

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