Hyperion Therapeutics Announces Enrollment of First Patient in Phase 2 Clinical Trial in Patients With Hepatic Ence...( SOUTH SAN FRANCISCO Calif. Feb. 2...),Health

SOUTH SAN FRANCISCO, Calif., Feb. 25 /PRNewswire/ -- Hyperion Therapeutics, Inc. today announced that the first patient has been enrolled in a Phase 2 clinical trial of AMMONUL(R) (sodium phenylacetate and sodium benzoate) Injection 10%/10% in patients with Grade III or IV hepatic encephalopathy (HE). The randomized, double-blind study is designed to evaluate the safety and efficacy of AMMONUL versus standard of care in hospitalized adults. The FDA has granted AMMONUL orphan drug designation for the treatment of Grade III and IV HE.

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"With no therapies currently FDA-approved, there remains considerable unmet medical need in the treatment of hepatic encephalopathy," said Roger Williams M.D., Director of the Institute of Hepatology, University College, London. "The Phase 2 trial of AMMONUL will provide us with critical insight in systematically evaluating our hypothesis that ammonia plays an important role in the pathogenesis of this multi-factorial disease process."

About Hepatic Encephalopathy

Hepatic encephalopathy (HE) is a serious, progressive and potentially reversible neuropsychiatric disorder caused by the accumulation of nitrous-containing toxic substances in the blood of patients with acute liver failure and chronic liver disease. Depending on disease severity, the degree of associated neurological impairment can range from mild alteration in cognitive and motor function to a rapid deterioration of consciousness level, coma, and death. The West Haven Criteria is often used to grade the mental state of HE patients with Grade 1 being the least severe (trivial lack of awareness) and Grade IV the most severe (coma).

Although the exact pathogenesis of HE remains unclear, experimental and clinical data suggest that ammonia is a contributing pathogenic factor. There are no therap
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