SAN DIEGO, Jan. 7 /PRNewswire/ -- 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 the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AST-120 for the treatment of Pouchitis.
Ocera will provide an overview of the Company and an update on AST-120 at the 26th Annual JP Morgan Healthcare conference being held today, at 2:30 pm (PT) at the Westin St. Francis Hotel in San Francisco in the Elizabethan Room.
“We are pleased by the FDA’s decision to grant orphan drug status for AST-120 in Pouchitis,” stated Dr. Laurent Fischer, president and CEO of Ocera Therapeutics. “This designation, along with the recent positive results from the exploratory Phase 2 trial for AST-120, allows us to expand the development of AST-120 for the treatment of Pouchitis, a frequent and severe complication in patients with a J-Pouch for which there are currently no drugs approved.”
Patients who suffer from ulcerative colitis often require a resection of the colon and creation of a J-Pouch to reduce the risk of cancer. A J-Pouch collects stool, but the pouch can become inflamed, resulting in a condition known as Pouchitis, which is associated with diarrhea, abdominal cramps, fever and dehydration. AST-120, an oral agent known to adsorb bile acids and bacterial toxins, as well as to mediate inflammation in the gastrointestinal tract, is currently being evaluated in a Phase 2 trial in patients with active Pouchitis.
Less than 100,000 patients in the United States suffer from Pouchitis which qualifies AST-120 for Orphan Drug status in this condition. Orphan Drug status was created by the FDA to encourage companies to develop medicines for the treatment of rare diseases by providing the developer with market exclusivity of the product for seven years, in addition to other incentives.
AST-120 was in-licensed from Kureha Corporation, Japan in 2005 and is currently being studied in a Phase 3 trial in Fistulizing Crohn’s disease.
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 is based in San Diego and is pursuing the development of AST-120 in Crohn’s disease, Pouchitis and conducting proof of concept trials in other gastrointestinal and liver diseases including, 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. Additional information on the Company can be found at http://www.oceratherapeutics.com.
For more information on Pouchitis, visit the Crohn’s and Colitis Foundation of America website at http://www.ccfa.org.
mhill@pnlifesciences.com lfischer@ocerainc.com
CONTACT: Media, Melissa Hill of Porter Novelli Life Sciences,
+1-619-849-6004, mhill@pnlifesciences.com, for Ocera Therapeutics, Inc.; or
Company, Laurent Fischer of Ocera Therapeutics, Inc., +1-858-436-3901,
lfischer@ocerainc.com
Web site: http://www.oceratherapeutics.com/
