VIENNA, April 16 /PRNewswire/ -- 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.
About ASTUTE Study
ASTUTE is a randomized, double blind, multicenter study evaluating 148 patients with liver cirrhosis and MHE. The study employed the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), a validated instrument developed by Dr. Christopher Randolph of Loyola University in Chicago. RBANS was used to screen cirrhotic patients for evidence of MHE and study eligibility, and found that MHE was present in the majority of patients screened. The study is designed to evaluate the effects of AST-120 compared to placebo on neurocognitive function using a variety of validated instruments. In addition, quality of life and clinical global evaluations as well as safety assessments are being conducted.
About AST-120
AST-120 is a novel proprietary spherical carbon adsorbent with a selective adsorption profile for a variety of unwanted substances and toxins, most importantly ammonia, the primary toxin linked to hepatic encephalopathy in patients with liver cirrhosis. AST-120 also adsorbs other substances, which may be responsible for conditions including Irritable Bowel Syndrome (IBS), and pouchitis. Adsorbed substances include ammonia, indoles (serotonin), histamine, bile acids, advanced glycation endproducts (AGE), and certain bacterial toxins. Ocera licensed the compound from Kureha Corporation (Japan) in 2005. AST-120 has been used chronically by over 360,000 patients and studied in over 3,000 patients worldwide.
About Hepatic Encephalopathy
Hepatic Encephalopathy (HE) is a neuropsychiatric condition in which severe liver disease contributes to an accumulation of toxic substances, including ammonia that impair brain function. HE ranges in severity from mild personality changes to disorientation, delirium, coma and death. It has been reported that over 50% of patients with cirrhosis of the liver who do not have evidence of overt HE will still have neuropsychiatric impairment if tested. This more subtle impairment has been termed MHE, and has been associated with impaired quality of life, job loss and increased risk of motor vehicle accident in these patients. MHE is currently rarely diagnosed by physicians and there are no approved treatments for MHE.
About Ocera Therapeutics, Inc.
Ocera Therapeutics, based in San Diego, California, USA, is a privately held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat acute and chronic liver diseases and a broad range of gastrointestinal disorders. In addition to AST-120, Ocera is developing OCR-002, an ammonia detoxification agent, for the treatment of hospitalized patients with acute hepatic encephalopathy and acute liver failure. Ocera has raised $62.5 million dollars in venture financing from Domain Associates, Sofinnova Ventures, Thomas, McNerney & Partners, Montagu Newhall and InterWest Partners. Additional information on the company can be found at www.oceratherapeutics.com.
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