Ocera IIb Study Completes Enrollment

Ocera Therapeutics has completed enrollment for its Phase IIb ASTUTE Study (AST-120 Used to Treat Hepatic Encephalopathy). Data is expected mid-2010.

AST-120 absorbs ammonia and other gut derived toxins that are factors in the underlying cause of mild hepatic encephalopathy (MHE), a neurocognitive disorder present in a majority of patients with cirrhosis of the liver. Because MHE leads to a change in cognitive function including personality changes and intellectual impairment, the disorder has a profound negative impact on quality of life.

The randomized, double blind, placebo-controlled study, enrolled 150 patients with MHE. Subjects were randomly assigned to receive either AST-120 or placebo for as many as eight weeks. The study will evaluate the effects of AST-120 on neurocognitive function using a variety of validated instruments. In addition, quality of life, clinical global evaluations and safety assessments will be conducted.

“This first study of MHE enrolled ahead of schedule and established prospectively that a majority of patients with otherwise stable cirrhosis suffer from MHE — which speaks to the pent-up demand for a safe and well tolerated treatment option for MHE patients. The Phase IIb study is the first to use a more sensitive and validated assessment instead of the West Haven Conn criteria which has been deemed unreliable in this population,” stated Laurent Fischer, M.D., chief executive officer of Ocera Therapeutics. “There is a great unmet medical need to routinely diagnose and offer a safe and well tolerated treatment option for the majority of the people with liver cirrhosis who have MHE but are not aware of the specific disorder.”