Hyperion Therapeutics’ Glycerol Phenylbutyrate Meets Primary Endpoint in Phase II Study in Episodic Hepatic Encephalopathy
Published: Jun 06, 2012
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Hyperion Therapeutics, Inc. has announced that its phase II study of glycerol phenylbutyrate, an investigational drug for the treatment of episodic hepatic encephalopathy (HE), met its primary endpoint: the proportion of patients experiencing at least one HE event was significantly lower on glycerol phenylbutyrate versus placebo (21.1% vs. 36.4%; p = 0.0214). The rate of adverse events was similar for glycerol phenylbutyrate versus placebo. The company is planning to request an end of phase II meeting with the US Food and Drug Administration to review the data and plans for phase III.