Ocera Therapeutics Initiates A Phase 2 Trial For Active Pouchitis

Main Category: Crohn's / IBD
Also Included In: Clinical Trials / Drug Trials;  Conferences
Article Date: 28 Mar 2007 - 0:00 PDT

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Ocera Therapeutics Inc. announced today that a Phase 2 exploratory study for AST-120 in patients with active pouchitis was initiated at Cleveland Clinic and that it has also met the 50 percent enrollment target in its pivotal Phase 3 trial of AST-120 in fistulizing Crohn's disease. The Phase 2 exploratory study will be conducted by Bo Shen, M.D. at Cleveland Clinic and will evaluate the efficacy and safety of AST-120. In addition, Ocera's President and CEO, Laurent Fischer, M.D. will provide an update on the company's programs at the BioCentury and Thomson Financial's 2007 Future Leaders in the Biotech Industry Conference. The Company presentation will take place on Thursday, March 29, 2007 from 1:30-1:55 p.m.

Patients who suffer from Ulcerative Colitis (UC) often require a resection of the colon and the creation of an illeal pouch-anal anastomosis (IPAA) or "pouch" to reduce the risk of cancer and the need for long-term medications. The IPAA often becomes chronically inflamed, a condition known as pouchitis, which is associated with diarrhea, abdominal cramps, fever and dehydration. Pouchitis is the most common long-term complication of IPAA and occurs in 40 percent of IPAA patients. A bacterial etiology with an abnormal production of bacterial toxins and abnormal metabolism of bile acids is believed to contribute to the chronic inflammation of the pouch. The current standard of care for pouchitis includes treatment with antibiotics such as ciprofloxacin and metronidazole and has a relapse rate of 60 percent. No treatment is currently approved for pouchitis, which affects an estimated 40,000 to 60,000 patients in the U.S., qualifying pouchitis as an Orphan Drug.

"We are pleased to initiate this exploratory trial with AST-120 for the treatment of active pouchitis where there is a significant unmet medical need," said Bo Shen, M.D., Principal Investigator at the Center for Inflammatory Bowel Disease, Cleveland Clinic. "In vitro adsorption studies have shown that AST-120 has a high adsorption capacity for bile acids and is expected to protect the intestinal mucosa of the pouch from inflammation exacerbated by bile acids."

Phase 3 Trial in Fistulizing Crohn's Disease

Ocera also announced today that its first pivotal Phase 3 trial in fistulizing Crohn's disease has met 50 percent of its enrollment target of 240 patients.

"I am pleased that our Fistula Healing with AST-120 (FHAST1) trial is progressing as scheduled to assess the efficacy and safety of AST-120 in inducing a reduction in the number of draining fistulas in Crohn's disease," stated Xavier Frapaise, M.D., Chief Medical Officer at Ocera. "We look forward to exploring the platform potential of AST-120 with the proof-of- concept pouchitis trial initiated by the Cleveland Clinic."

AST-120 was in-licensed from Kureha Corporation of Japan in 2005 and is currently in a Phase 3 pivotal trial for the treatment of fistulizing Crohn's disease (FHAST1) in North America and Europe. Ocera is planning to initiate other proof-of-concept trials with AST-120 in 2007 in additional gastrointestinal and liver diseases.

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 raised $26.5 million in venture financing from Domain Associates, Sofinnova Ventures and Thomas, McNerney & Partners. Additional information on the Company can be found at http://www.oceratherapeutics.com.

Ocera Therapeutics, Inc.
http://www.ccfa.org

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