Biotech Values

[DewDiligence]

ICPT presents post-hoc analysis of three fibrosis biomarkers from FLINT study:

http://finance.yahoo.com/news/intercept-presents-data-analyses-non-150000386.html

The post-hoc analysis to be presented at AASLD evaluated the early predictive value of three known non-invasive fibrosis tests in identifying patients who experienced improvement in fibrosis: FIB-4, APRI and NFS. Each was assessed at baseline and over the course of treatment in the study population and then correlated with histologic changes observed in the 200 OCA and placebo patients who completed the trial with a repeat liver biopsy.

The analysis demonstrated that OCA treatment of NASH patients in FLINT led to a statistically significant decrease in FIB-4 from baseline as compared to placebo (-0.246 OCA vs -0.047 placebo; p=0.0076).

…Similarly, OCA-treated patients experienced a significant decrease in APRI as compared to placebo (-0.243 OCA vs. --0.082 placebo; p=0.0009)…

On average, OCA treatment reduced the FIB-4 score to <1.3 and the APRI score to <0.5, the respective cut-off values associated with advanced fibrosis, while placebo patients remained above these cut-offs.

While NFS declined in the OCA-treated patients and increased in the placebo patients, it did not appear to be sensitive to changes in fibrosis.

Two of out three ain’t bad, LOL. More from the PR:

Advanced liver fibrosis has been shown to be the best predictor of liver-related mortality in patients with NASH, and the current standard for staging fibrosis is liver biopsy. The FLINT results provide support for the use of both the FIB-4 and APRI scores as potential non-invasive alternative means for monitoring fibrosis changes in response to treatment through simple blood tests.

FIB-4 is calculated using an algorithm based on aspartate aminotransferase (AST), alanine aminotransferase (ALT), platelet count and age, while APRI is based on AST and platelet count alone.