Dr. Rockey explained, "The study results provide new insight into the importance of ammonia in the pathogenesis of hepatic encephalopathy (HE). Based on its safety profile, Hyperion's investigational drug, glycerol phenylbutyrate (GPB), or "Ravicti", shows promise as a novel therapeutic agent."
Dr. Rockey explained,
The study enrolled 178 total patients, of whom 59 were on Rifaximin at baseline, including 29 in the placebo arm and 30 in the active arm. Among the 119 patients not on Rifaximin at baseline, there was a highly statistically significant reduction among GPB treated patients in both the percentage of patients with events (10% vs 32%; p=0.003) as well as the total number of HE events (7 vs. 31; p < 0.001). Among patients on Rifaximin at baseline, there was no difference in the number of patients with events or total events. Ammonia was similarly lowered on GPB among patients taking (67 vs. 91 umol/L; p=0.13) or not taking (36 vs. 43 umol/L; p=0.08), although the differences were not statistically significant due to the smaller sample size. Patients on Rifaximin at baseline had higher ammonia levels than those not on Rifaximin.
The abstract is published online at https://www.aasld.org/lm2012. 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
Hyperion also indicated that it was hosting and webcasting an analyst and investor briefing to recap the Plenary Session presentation tonight,
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
About Glycerol Phenylbutyrate
Glycerol phenylbutyrate, an investigational drug, is a pre-pro-drug of phenylacetic acid, the active moiety of BUPHENYL®, the only branded therapy currently
BUPHENYL® is a registered trademark of
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 filed with the
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