Ocera Therapeutics presents data on prevalence of neurocognitive impairment in cirrhotic patients

Ocera Therapeutics, Inc. presented an analysis of the prevalence of neurocognitive impairment in ambulatory cirrhotic patients. The data came from the screening period of the ASTUTE Study, an ongoing Phase 2b study evaluating the safety and efficacy of AST-120 (spherical carbon adsorbent) in the treatment of mild hepatic encephalopathy (MHE). The poster was presented yesterday at the annual meeting of the European Association for the Study of Liver (EASL) in Vienna, Austria. Efficacy and safety data from the ASTUTE study are expected in the summer of 2010.

"ASTUTE is the first prospective study screening patients with stable cirrhosis for MHE using the RBANS, a diagnostic test recommended in by the International Society for Hepatic Encephalopathy and Nitrogen Metabolism (ISHEN). The findings establish the fact that a majority of patients have a neurocognitive deficit and suffer from MHE, an indication for which there are no drugs approved and with an unmet need for a safe and well-tolerated treatment option," stated Dr. Laurent Fischer, CEO of Ocera Therapeutics. "AST-120 is an attractive treatment option for MHE because of its well-established safety profile, and its demonstrated ability to reduce circulating ammonia levels and brain edema in a model of cirrhosis."

Dr. Roger Butterworth, President of ISHEN noted, "the importance of MHE and its prevalence in patients with liver cirrhosis has been underestimated until now. This landmark study shows that a majority of patients with cirrhosis indeed suffer from MHE.  We should consider screening all patients with severe liver disease for MHE and evaluate treatment options as this is a reversible condition."

The company also presented data today demonstrating the potential of AST-120 to lower ammonia and reduce brain edema (swelling) in a preclinical model of cirrhosis. The data support that high ammonia levels caused by cirrhosis of the liver is a primary factor for development of brain edema. Notably, AST-120 significantly reduced ammonia in a dose-dependent fashion and brain edema responded to the treatment.