SOUTH SAN FRANCISCO, Calif., Jun 06, 2012 (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.
"I am very encouraged by these results and the potential for glycerol phenylbutyrate to address unmet needs in patients with episodic HE. The data suggest that further exploration of the possible benefits of this agent in patients is warranted," said Don Rockey, MD, Professor of Medicine and Chief of the Division of Digestive and Liver Diseases at the University of Texas Southwestern Medical Center, who served as a principal investigator.
About Hyperion Therapeutics
Hyperion Therapeutics is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat disorders in the areas of orphan diseases and hepatology. Hyperion is developing glycerol phenylbutyrate for two orphan indications: urea cycle disorders (brand name, Ravicti(TM)) and hepatic encephalopathy.
BUPHENYL(R) is a registered trademark of Ucyclyd Pharma, Inc.
SOURCE: Hyperion Therapeutics, Inc.
http://www.marketwatch.com/story/hyperion-therapeutics-glycerol-phenylbutyrate-meets-primary-endpoint-in-phase-ii-study-in-episodic-hepatic-encephalopathy-2012-06-06
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