San Diego, CA, September 19, 2007 – Ocera Therapeutics, Inc., a privately-held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat gastrointestinal and liver diseases, announced today that it has initiated a multicenter double-blind placebo controlled Phase 2 study evaluating the efficacy and safety of AST-120 in patients with non-constipating Irritable Bowel Syndrome (IBS). The study will be conducted at four centers in Belgium.
“We are very pleased to initiate this proof of concept trial with Professor Jan Tack, the principal investigator and an expert in the field of IBS at the University of Leuven in Belgium,” said Laurent Fischer, M.D., President of Ocera Therapeutics. “IBS is a chronic disorder affecting 20 percent of the Western population and is characterized by abdominal pain, discomfort and alterations in bowel habits for which there are very few safe treatment options available today.”
The cause of IBS remains unclear and is thought to be the result of a number of different factors including abnormalities of motility, sensitivity and low-grade inflammation. IBS is the most frequent disease diagnosed by gastroenterologists and is estimated to cost the U.S. healthcare system $30 billion per year.
AST-120, an oral adsorbent used in more than 200,000 patients in Japan is currently being investigated in a pivotal Phase 3 trial in fistulizing Crohn’s disease in North America and Europe, and is known to adsorb some toxins and mediators of inflammation from the gastrointestinal tract, preventing local toxicity and systemic absorption.
“Our center focuses on functional gastrointestinal disorders, such as IBS, and is involved with a large number of studies evaluating new drugs to treat patients suffering from this disorder,” said Jan Tack, M.D., Ph.D., Professor of Internal Medicine and Head of the Department of Pathophysiology, at the University of Leuven, Belgium. “The unique mechanism of action and well established safety profile of AST-120 in other diseases makes it an attractive drug to study for the treatment of IBS, a disease for which there are few drugs approved.”
Ocera in-licensed AST-120 from Kureha Corporation in Japan and has recently initiated other proof-of-concept trials with AST-120 in Pouchitis, Hepatic Encephalopathy and Proton Pump Inhibitor-resistant Gastro Esophageal Reflux Disease.
About Irritable Bowel Syndrome
Irritable bowel syndrome (IBS) is referred to as spastic colon, mucous colitis, spastic colitis, nervous stomach or irritable colon and affects up to 20 percent of the population. It is the most common disease diagnosed by gastroenterologists (doctors who specialize in medical treatment of disorders of the stomach and intestines) and one of the most common disorders seen by primary care physicians. For more information on irritable bowel syndrome visit the International Foundation for Functional Gastrointestinal Disorder at www.aboutibs.org.
About Ocera Therapeutics, Inc.
Ocera Therapeutics, Inc. is a privately-held biopharmaceutical company focused on the licensing, development and commercialization of proprietary clinical candidates to treat a broad range of gastrointestinal and liver diseases. Ocera Therapeutics is based in San Diego and is pursuing the development of AST-120 in Crohn’s disease, and other gastrointestinal and liver diseases including pouchitis. Ocera has raised $26.5 million dollars in venture financing from Domain Associates, Sofinnova Ventures and Thomas, McNerney & Partners. Additional information on the Company can be found at www.oceratherapeutics.com.
For information on Ocera Therapeutics’ clinical trials in Crohn’s disease, please visit www.clinicaltrials.gov. Key word: AST-120
Ocera Therapeutics, Inc. Initiates Phase 2 Clinical Trial in Hepatic Encephalopathy
San Diego, CA, September 19, 2007 – Ocera Therapeutics, Inc., a privately-held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat gastrointestinal and liver diseases announced today that it has initiated a Phase 2 study evaluating the efficacy and safety of AST-120 in patients with Hepatic Encephalopathy (HE), a complication of liver cirrhosis associated with changes in behavior ranging from confusion and drowsiness to coma.
“We are pleased to initiate this Phase 2 study with Dr. Paul Pockros and the Liver Research Consortium at Scripps Clinic and in 14 other centers in the U.S.,” said Laurent Fischer, M.D., President of Ocera Therapeutics. “Hepatic Encephalopathy is a debilitating condition affecting the mental faculty of patients suffering from chronic liver failure, that can eventually lead to hospitalization and coma, and for which treatment options are limited.”
Hepatic Encephalopathy occurs when the liver cannot properly metabolize toxins such as ammonia, which can cause damage to the brain. Hepatic Encephalopathy can occur in approximately half of all patients with liver cirrhosis.
AST-120, an oral adsorbent used in more than 200,000 patients in Japan is currently being investigated in a pivotal Phase 3 trial in fistulizing Crohn’s disease in North America and Europe, and is known to adsorb some toxins and mediators of inflammation from the gastrointestinal tract, including ammonium, thereby preventing the absorption of toxins in the bloodstream.
“Agents such as neomycin and lactulose, the current standard of care, are not very effective and lactulose, which has a potent laxative effect, is poorly tolerated,” said Dr. Paul J. Pockros, Head of Gastroenterology/Hepatology, Director of the Liver Disease Center at Scripps Clinic, and Director of the SC Liver Research Consortium, a group of 50 centers throughout the U.S. which participate in large multi-center liver disease trials. “The unique mechanism of action and well established safety profile of AST-120 in other diseases makes it an attractive drug to study for the treatment of HE, a disease for which there are few drugs approved.”
Ocera in-licensed AST-120 from Kureha Corporation in Japan and has recently initiated other proof-of-concept trials with AST-120 in Irritable Bowel Syndrome (IBS), Pouchitis and Proton Pump Inhibitor-resistant Gastro Esophageal Reflux Disease.
About Hepatic Encephalopathy
Hepatic Encephalopathy occurs as a complication of liver disorders such as cirrhosis or hepatitis and when the liver cannot properly metabolize toxins and turn them into harmless substances in the body. One substance believed to be particularly harmful is ammonia, which is produced by the body when proteins are digested. Ammonia is normally made harmless by the liver. When toxins, such as ammonia build up in the bloodstream they can damage the brain and nervous system. More information on HE can be found at www.hepatitis-central.com
About Ocera Therapeutics, Inc.
Ocera Therapeutics, Inc. is a privately-held biopharmaceutical company focused on the licensing, development and commercialization of proprietary clinical candidates to treat a broad range of gastrointestinal and liver diseases. Ocera Therapeutics is based in San Diego and is pursuing the development of AST-120 in Crohn’s disease and other gastrointestinal and liver diseases including Pouchitis. Ocera has raised $26.5 million dollars in venture financing from Domain Associates, Sofinnova Ventures and Thomas, McNerney & Partners. Additional information on the Company can be found at www.oceratherapeutics.com.
For information on Ocera Therapeutics’ clinical trials, please visit www.clinicaltrials.gov. Key word: AST-120
