ARTICLE | Clinical News
Hyperion's HE product meets Phase II endpoint
June 7, 2012 12:58 AM UTC
Hyperion Therapeutics Inc. (South San Francisco, Calif.) said glycerol phenylbutyrate met the primary endpoint of a lower proportion of patients who experienced at least one hepatic encephalopathy (HE) event vs. placebo in the Phase II HALT-HE trial in 178 patients (21.1% vs. 36.4%, p=0.0214). Patients were required to have at least two documented HE events in the six months prior to enrollment and continued to receive standard of care including lactulose and/or Xifaxan rifaximin. Hyperion plans to request an end-of-Phase II meeting with FDA. Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) markets Xifaxan. ...