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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.
News For ICPT From The Last 14 Days
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October 22, 2014
08:40 EDTICPTDeutsche Bank biotech analyst holds an analyst/industry conference call
Biotech Analyst Young provides a review of the ICPT/GNFT thesis on an Analyst/Industry conference call to be held on October 22 at 11 am.
06:43 EDTICPTNASH market big enough for multiple players, says Deutsche Bank
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October 15, 2014
09:21 EDTICPTIntercept pullback a buying opportunity, says Summer Street
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07:24 EDTICPTIntercept management to meet with Deutsche Bank
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October 9, 2014
09:03 EDTICPTIntercept pullback a buying opportunity, says Summer Street
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