Additional Results of Global Primary Biliary Cirrhosis Study Group Analysis to be Presented at AASLD Annual Meeting
Data from over 3,895 PBC patients collected and pooled by an independent group of 15 academic medical centers across eight countries have been analyzed by the
"This international collaboration has assembled data from the largest group of PBC patients to have ever been evaluated since PBC was first described over 150 years ago," commented Dr.
The two abstracts from the
Primary Biliary Cirrhosis and the
PBC is an autoimmune chronic liver disease that typically affects women. The disease progresses in those patients who have an inadequate response to therapy and may require a liver transplant or die. Biochemical assessments of liver function, particularly by measuring plasma levels of ALP and bilirubin, are typically used by physicians to diagnose and manage PBC patients. There is a log-linear relationship between ALP levels and transplant-free survival; higher levels are associated with a worse prognosis. Accordingly, the relationship between these biochemical assessments of liver function and adverse clinical outcomes is highly important in the selection of appropriate endpoints in therapeutic clinical trials.
Data from the
Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat orphan and more prevalent liver diseases utilizing its expertise in bile acid chemistry. The company's lead product candidate, obeticholic acid (OCA), is a bile acid analog and first-in-class agonist of the farnesoid X receptor (FXR). OCA is initially being developed for the second line treatment of primary biliary cirrhosis (PBC) in patients with an inadequate response to, or who are unable to tolerate, ursodiol, the only approved therapy for this indication. OCA has received orphan drug designation in both
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This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the analyses of the
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