Intercept Presents New Data At AASLD Examining The Effects Of Ocaliva® (Obeticholic Acid) On Non-Invasive Assessments Of Liver Fibrosis In Patients With PBC

NEW YORK, Nov. 11, 2016 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced results from three new exploratory analyses of the Phase 3 POISE trial of Ocaliva ® (obeticholic acid) in patients with primary biliary cholangitis (PBC). The analyses will be presented at the American Academy for the Study of Liver Diseases (AASLD) Annual Meeting (The Liver Meeting ®), taking place in Boston, MA from November 11-15. 

The POISE trial evaluated the safety and efficacy of once-daily treatment with Ocaliva in PBC patients with an inadequate therapeutic response to, or who are unable to tolerate, ursodeoxycholic acid (UDCA). Of 216 patients randomized to three treatment arms—placebo, Ocaliva 5 mg titrated to 10 mg or Ocaliva 10 mg—93% continued receiving UDCA.

The first POISE presentation (abstract #209) evaluated the effects of Ocaliva on non-invasive assessments of liver fibrosis using both transient elastography (Fibroscan™) and the AST to Platelet Ratio (APRI). These tests have been shown to be effective in predicting clinical outcomes in PBC, and Ocaliva-treated patients experienced improvements in both compared with those receiving placebo. In patients with transient elastography assessments at baseline and month 12 (approximately 43% of the study population), only Ocaliva-treated patients experienced a reduction in liver stiffness below 16.9 kPa, a threshold associated with the presence of cirrhosis. Mean liver stiffness reduction was observed in the 10 mg Ocaliva group compared to placebo. In patients with a baseline APRI score above 0.54 (a threshold associated with increased risk of adverse clinical outcomes in PBC patients), 35% of Ocaliva-treated patients compared to 13% of placebo-treated patients experienced an improvement to below 0.54 at the end of the 12 month double-blind phase.

"Because liver biopsies are not routinely used for staging patients with PBC, it is important that we explore non-invasive strategies to evaluate the effects of new therapies like Ocaliva on liver fibrosis," said Gideon Hirschfield, M.D., Professor and Honorary Consultant Hepatologist, Centre for Liver Research at the University of Birmingham, UK, who presented the data. "These results are very promising, and the ongoing Phase 4 COBALT trial of Ocaliva will provide us with a more definitive understanding of the drug's ability to improve non-invasive measures of liver fibrosis and reduce the risk of clinical outcomes in our patients with PBC."

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