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Intercept Issues Added Results of Global Primary Biliary Cirrhosis Study, Says Ursodiol Failed to Meet Poise Endpoint in 59% of Patients

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Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic liver diseases, today announced additional details relating to the analysis presented by the Global Primary Biliary Cirrhosis Study Group (Study Group) at the annual meeting of the European Association for the Study of the Liver (EASL) held in Amsterdam on April 24-28, 2013. The Study Group presented an analysis of data from over 2,100 primary biliary cirrhosis (PBC) patients, among whom 981 patients met Intercept's ongoing Phase 3 POISE trial entry criteria at the time they initiated ursodiol therapy of having an alkaline phosphatase (ALP) level exceeding 1.67 times upper limit normal (ULN) and/or an abnormal bilirubin level. The analysis of this cohort of patients from the Study Group further substantiates the primary endpoint used in POISE as being strongly predictive of adverse clinical outcomes such as liver transplant and death in PBC patients.

"This independent analysis from the Study Group further validates the use of a surrogate endpoint in PBC trials to predict long-term outcomes," said Mark Pruzanski, M.D., Chief Executive Officer and President of Intercept. "Our selection of the POISE trial endpoint was based on a recent emerging consensus of leading PBC opinion leaders and we are glad to see that the Study Group data analyzed to date support its clinical utility."

The data show that after one year of ursodiol therapy 58.7% of the patient cohort (n=576/981) had an inadequate therapeutic response as determined by failure to meet the POISE trial primary endpoint, which is defined as the achievement of both an ALP level of less than 1.67 times ULN (with a minimum 15% reduction from baseline) together with a normal bilirubin level. In the non-responder group, 30.0% of patients went on to require a liver transplant or die (n=173/576) as compared to 12.6% of patients in the responder group (n=51/405), reflecting a 2.4-fold higher event rate for the non-responders (p=4.5x10E-10).

In order to censor out deaths due to causes other than PBC-associated liver failure, the Study Group, among other things, analyzed a younger subgroup of patients who were under 60 years old (n=666) at the time they initiated ursodiol therapy. In this subgroup, 61.3% of patients (n=408/666) failed to meet the POISE endpoint after one year of ursodiol therapy and 26.2% of these patients went on to require a liver transplant or die (n=107/408), as compared to 7.4% of patients in the responder group (n=19/258), reflecting a 3.6-fold higher event rate for the non-responders (p=1x10E-7).

The event rate among the responders in this subgroup was 41.3% lower than the event rate of the responder group in the overall patient cohort that included older patients. We believe that this difference is likely due to the greater exclusion of mortality unrelated to PBC in the younger patient subgroups, resulting in even greater differentiation of the responder and non-responder groups.

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