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March 16, 2014
14:37 EDTICPTIntercept Phase 3 POISE trial of OCA meets primary endpoint
Intercept Pharmaceuticals announced that its international Phase 3 POISE trial of obeticholic acid. OCA, for the treatment of primary biliary cirrhosis, PBC, demonstrated that OCA, at both a 10 mg dose and a 5 mg dose titrated to 10 mg, met the trial's primary endpoint of achieving a reduction in serum alkaline phosphatase to < 1.67x ULN with a = 15% reduction from baseline and a normal bilirubin level after 12 months of therapy. The proportion of patients meeting the POISE primary endpoint was: 10% in the placebo group, 47% in the 10 mg OCA group and 46% in the 5-10 mg OCA group in an intention to treat analysis. In addition, both OCA dose groups met pre-specified secondary endpoints of improvements in other liver function parameters, including GGT, ALT, AST and total bilirubin. In order to evaluate the clinical relevance of the POISE primary endpoint, Intercept sponsored an independent study conducted by the Global PBC Study Group, consisting of 15 leading PBC centers in eight countries that contributed to a clinical outcomes database of more than 6,000 PBC patients. In this study, patients who did not achieve the POISE endpoint after one year were shown to have a greatly increased risk of liver transplant or death compared to those who achieved the endpoint. The PBC Supergroup has also previously confirmed that higher ALP levels in patients correlate with increased risk of liver transplant and death.
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November 14, 2014
15:22 EDTICPTIntercept CEO says company 'very well-positioned' in terms of balance sheet
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