In vitro adsorption studies have demonstrated that AST-120 has a high adsorption capacity for bile acids and bacterial toxins and is expected to protect the intestinal mucosa of the pouch from inflammation.
AST-120 was in-licensed from Kureha Corporation, Japan in 2005. Ocera announced last week that it completed enrollment in FHAST1, the Fistula Healing with AST-120 Phase 3 pivotal trial in Crohn's disease conducted in North America, Europe and Israel. Ocera also recently initiated proof-of-concept trials with AST-120 in Irritable Bowel Syndrome and Hepatic Encephalopathy.
About the Pouchitis Phase 2 Study
The proof-of-concept study conducted under investigator IND at Cleveland Clinic is evaluating 20 patients with active pouchitis treated with open label AST-120, 2 grams tid. The Primary efficacy endpoint is remission as defined by a Pouchitis Disease Activity Index (PDAI) less than 7 points which includes clinical, endoscopy and histology scores. Secondary endpoints include safety, clinical response measured by a decrease of PDAI of a least three points and Global Quality of Life score.
About Ocera Therapeutics, Inc.
Ocera Therapeutics, Inc. is a privately-held biopharmaceutical company
focused on the licensing, development and commercialization of proprietary
compounds 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, Hepatic Encephalopathy, Irritable Bowel Syndrome and
Proton Pump Inhibitor-resistant Gastroesophageal Reflux Disease. Ocera
Therapeutics has raised $26.5 million dollars in venture financing from
Domain Associates, Sofinnova Ventures and Thomas, McNerney & Partners.
|SOURCE Ocera Therapeutics, Inc.|
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