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Ocera Therapeutics Presents Clinical Data Demonstrating AST-120 Relieves Pruritus in Patients with Liver Cirrhosis at the 60th Annual AASLD Meeting

AST-120 Also Shown to Reduce Ammonia and Brain Swelling in Rat Model of Cirrhosis

BOSTON, Nov. 2 /PRNewswire/ -- Ocera Therapeutics, Inc. announced today that AST-120 (spherical carbon adsorbent) was shown to reduce the severity of pruritus (itching) in patients with chronic liver disease. The data were presented at the 60th Annual Meeting of the American Association for the Study of Liver Diseases in a presentation titled, "Oral AST-120 (Spherical Carbon Adsorbent) Improves Pruritus and Lowers Serum Bile Acids in Patients with Cirrhosis of Various Etiologies." These findings comprised a secondary endpoint of a larger Phase 2 study demonstrating the efficacy, safety and tolerability of AST-120 in cirrhotic patients with mild hepatic encephalopathy (MHE).

Patients treated with AST-120 had a statistically significant reduction in itch with a four-week treatment course. The benefit was seen as early as the first week of therapy and continued to improve over the four weeks of treatment. Mean reduction in pruritus by 100mm VAS at Week 4 was 30mm for AST-120 treated subjects vs. 5mm for placebo treated subjects, p=0.03. The reduction in itch was significantly correlated with a reduction in serum bile acids, which are thought to play a key role in the pathogenesis of pruritus in this patient population.

"Pruritus affects up to 15 percent of hepatitis C patients, and can be devastating for chronic liver disease patients," said Averell Sherker, M.D. Director of the Center for Liver Diseases at the Washington Hospital Center and the presenting investigator. "The efficacy seen with AST-120 in this limited sample of patients, coupled with its well established safety profile, suggests that it has the potential to become an important treatment option for these patients in the future."

In a separate session at AASLD, Christopher Rose, Ph.D., Assistant Professor in the Department of Medicine at Universite de Montreal, presented the results of a preclinical study conducted with AST-120 in a rat model of cirrhosis. In that study, titled "AST-120 (spherical carbon adsorbent) attenuates brain edema and lowers arterial ammonia in bile-duct ligated rats," the administration of AST-120 resulted in a statistically significant reduction in serum ammonia levels and brain swelling. Increased serum ammonia is recognized as a central feature of hepatic encephalopathy and related complications.

The efficacy and safety of AST-120 in the treatment of MHE, the most frequent complication of cirrhosis, is currently being evaluated by Ocera in the ongoing ASTUTE Phase 2b study. MHE affects up to 60 percent of cirrhotic patients and is associated with neurocognitive deficits leading to an increased risk of car accidents, falls, loss of employment and reduced quality of life.

"AST-120 avidly binds ammonia, bile acids and many other potentially toxic substances from the lower gastrointestinal tract. In addition to showing great potential for the treatment of MHE and for the relief of pruritus, these data demonstrate AST-120 warrants further clinical evaluation for the treatment of other liver and gastrointestinal diseases," said Scott Harris, M.D. Ocera's Chief Medical Officer.

About AST-120

AST-120 is a novel proprietary microspherical carbon adsorbent with a selective adsorption profile for a variety of unwanted substances in the digestive tract. These substances may be responsible for a number of conditions, including hepatic encephalopathy (HE), irritable bowel syndrome (IBS), and pouchitis. The substances include ammonia, indoles (serotonin, octopamine), histamine, secondary bile acids, advanced glycation endproducts (AGE), and certain bacterial toxins. Ocera licensed the compound from the Kureha Corporation (Japan) in 2005.

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 in hepatic encephalopathy due to complications of cirrhosis and acute liver failure. Ocera has raised $62 million in venture financing from Domain Associates, Sofinnova Ventures, Thomas, McNerney & Partners, Montagu Newhall and InterWest Partners.

Posted: November 2009