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Hyperion Therapeutics Announces Results of Phase I Study in Patients With Liver Cirrhosis
Date:6/2/2009

days 1 or 15. There were no statistically significant differences in the PK characteristics when HPN-100 was given fasting on day 1 or with a meal on day 8. Excretion of the main metabolite PAGN was similar between healthy adults and cirrhotic subjects. Urinary PAGN after the first dose on Day 1 ranged from 42-49% of the administered dose, and the mean total excretion of PAGN after the last dose in the study (day 15) ranged from 25,152 to 31,431 umol in the four treatment groups

There were no SAEs or AEs leading to withdrawal during the study. The most common system organ class was "investigations" (32 events in 18 subjects), and of these the most frequent individual AEs were increased body temperature, which was reported in 10 subjects (all from Child-Pugh groups A, B, and C), and decreased platelet count, which was reported in 4 subjects in Child-Pugh group A and 1 subject in the healthy volunteer group. There were no overall consistent patterns across all subject groups in changes in mean hematology, biochemistry, and coagulation variables.

"Hepatic encephalopathy (HE) is a significant clinical problem," said Brendan M. McGuire, M.D. Medical Director of Liver Transplantation at the University of Alabama. "I am encouraged by the phase I study results and look forward to further clinical studies."

About HPN-100

HPN-100 is an investigational product that is a pre-pro-drug of phenylacetic acid, the active moiety of BUPHENYL(R), the only therapy currently FDA-approved as adjunctive therapy for the chronic management of patients with the most prevalent urea cycle disorders: carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) and argininosuccinic acid synthetase (AS) deficiencies. HPN-100, which is dosed orally in liquid form, is under clinical investigation as providing a potential alternative pathway to the urea cycle for the disposal of waste nitrogen through the renal excretion
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SOURCE Hyperion Therapeutics, Inc.
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