Oct. 2, 2012, 6:56 p.m. EDT
SOUTH SAN FRANCISCO, Calif., Oct 2, 2012 (GlobeNewswire via COMTEX) -- Hyperion Therapeutics, Inc. announced today that the results of the HALT-HE Study will be presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) (The Liver Meeting(R)), taking place on November 9-13, 2012 in Boston, MA. The presentation, "Randomized, controlled, double-blind study of glycerol phenylbutyrate in patients with cirrhosis and episodic hepatic encephalopathy," will be made on Monday, November 12, 2012, at 8:45 a.m. ET in the Presidential Plenary Session I in the Hynes Convention Center Auditorium.
The abstract is published online at https://www.aasld.org/lm2012 and summarizes the following results: the study met its primary endpoint, a significant reduction in patients with Hepatic Encephalopathy (HE) events, and supports ammonia (NH3) as important in HE pathogenesis. The HALT-HE study was a Phase II, multi-center, randomized, double-blind trial of glycerol phenylbutyrate vs. placebo in 178 patients with episodic HE recruited from 28 sites in the United States, 9 sites in Russia and 7 sites in Ukraine.
About Hepatic Encephalopathy
HE is a serious but potentially reversible neurological disorder that can occur in patients with cirrhosis of any etiology or acute liver failure. HE comprises a spectrum of neurological signs and symptoms ranging from mild (e.g. minimal disorientation) to severe (e.g. coma, death) and is believed to occur when the brain is exposed to gut-derived toxins such as ammonia that are normally removed from the blood by a healthy liver. Based on the current epidemiological literature, Hyperion estimates that there are approximately one million patients in the United States with cirrhosis, of whom approximately 140,000 have overt HE.
About Glycerol Phenylbutyrate
Glycerol phenylbutyrate, an investigational drug, is a pre-pro-drug of phenylacetic acid, the active moiety of BUPHENYL(R), the only branded therapy currently FDA-approved as adjunctive therapy for the chronic management of patients with the most prevalent urea cycle disorders. Glycerol phenylbutyrate holds orphan product designations in the United States and Europe for the maintenance treatment of patients with urea cycle disorders (UCD) and in the United States for the intermittent or chronic treatment of patients with cirrhosis and any grade of hepatic encephalopathy.
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 Therapeutics is developing Ravicti(TM) (glycerol phenylbutyrate) for two orphan indications: UCD and HE.
BUPHENYL(R) is a registered trademark of Ucyclyd Pharma, Inc.
To the extent that statements contained in this press release are not descriptions of historical facts regarding Hyperion, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectations regarding the timing of the presentation of the results of the HALT-HE study in November. Hyperion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties relating to the business of the company in general, see Hyperion's Quarterly Report on Form 10-Q for the quarter ended June 30, 2012, and any subsequent filings with the Securities and Exchange Commission.
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SOURCE: Hyperion Therapeutics, Inc.