Ocera Therapeutics, Inc. announced today that the ASTUTE Study (AST-120 Used to Treat Hepatic Encephalopathy) has completed enrollment for its Phase 2B study ahead of schedule, with data expected mid 2010.
AST-120 adsorbs ammonia and other gut derived toxins that factor prominently 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. MHE patients are at increased risk of motor vehicle accidents, losing their job and eventually hospitalization due to acute hepatic encephalopathy.
"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 2B 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., CEO 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."
"The importance of MHE has, until recently, been under appreciated, but this landmark study, shows that we can no longer ignore MHE. The scope of the problem is simply too big to avoid and we should consider screening all patients with severe liver disease for neurocognitive deficits," said Dr. Kevin Mullen, Consultant Hepatologist and Professor of Medicine at Case Western Reserve University. "AST-120 is a potentially attractive treatment option for MHE because of its well established safety profile, which appears similar to placebo, and its lack of known interaction with other drugs."
The study is a randomized, double blind, multicenter study which enrolled 150 patients with MHE. The study employed the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) to screen and evaluate cirrhotic patients for evidence of MHE, and found that MHE was present in over half of patients screened. Subjects were randomly assigned to receive either AST-120 or placebo for up to eight weeks. The study was designed to 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.
SOURCE Ocera Therapeutics, Inc.