Glycerol phenylbutyrate: Phase II data

Data from Part B of the double-blind, international Phase II HALT-HE trial in 178 patients with episodic HE showed that twice-daily 6 mL glycerol phenylbutyrate for 16 weeks met the primary endpoint of a lower proportion of patients who experienced >=1 HE event vs. placebo (21.1% vs. 36.4%, p=0.0214). The rate of adverse events was similar between treatment groups. Patients, which were required to have >=2 documented HE events in the 6 months prior to enrollment, continued to receive standard of care including lactulose and/or rifaximin. Part A of the trial was an open-label, dose-escalation lead-in phase evaluating safety and pharmacokinetics in about 10 patients with HE and cirrhosis. Hyperion said the data were submitted for presentation at the American Association for the Study of Liver Diseases meeting in Boston in November. The company plans to request an end-of-Phase II meeting with FDA. ...