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Preliminary Phase 2 Data of Ocera Therapeutics' OCR-002 for the Treatment of Liver Cirrhosis and Upper GI Bleeding Show Potent Ammonia Reduction
Date:5/29/2012

patients with liver cirrhosis (n=10) shows that OCR-002 is well tolerated up to 10g/24h and provides a significant, rapid and durable ammonia reduction to normal levels after 36 hours of treatment.  All patients tolerated study drug well for 5 days. There were no severe toxicities associated with the treatment and no incidence of HE, with patients doing well at the 30 day follow up. A rapid drop in ammonia from 80.01+/-13.44 uM at baseline to 41.95+/-4.99 uM was observed at 36 hours (ANOVA, p<0.05).

The Phase 2 clinical trial is ongoing and will enroll 48 patients with cirrhosis of the liver. The first part of the trial recently completed was an open-label study to confirm the safety and tolerability of OCR-002 seen in earlier clinical trials. The second phase is a double-blind, placebo-controlled study and will measure as the primary endpoint ammonia plasma concentration and improvement in HE as a secondary endpoint.

OCR-002, developed by Ocera Therapeutics, has received Orphan Drug designation in the U.S. and Europe and has fast track status in the U.S. OCR-002 is also being evaluated as a treatment of acute liver failure in the U.S. It is estimated that there are up to 1 million cirrhotic patients in the U.S., of which 150,000-200,000 patients are hospitalized due to complications of encephalopathy costing the healthcare system over $1.2 billion every year.

About OCR-002
Ocera in-licensed OCR-002 (ornithine phenylacetate), an ammonia scavenger designed to rapidly lower systemic hyperammonemia and treat hepatic encephalopathy (HE) in patients with liver cirrhosis and acute liver failure from University College of London. OCR-002, through its novel mechanism of action, directly lowers circulating blood levels of ammonia by enabling alternate metabolic pathways in the muscle and kidney in patients with liver failure and is patent protected until 2031. OCR-002 is being developed as an injectable for hospitaliz
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SOURCE Ocera Therapeutics, Inc.
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