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for diseases that affect millions of people, like irritable bowel syndrome and inflammatory bowel disease. But since Ocera’s most recent data presentation was about hepatic encephalopathy, that’s what I wanted to ask Fischer about the most.
At the Liver Meeting, the company reported on a study of 47 patients with mild hepatic encephalopathy. Patients were randomly assigned to get AST-120 or lactulose, the gold standard treatment for the disease. Researchers found that patients on the Ocera drug had a statistically significant decrease in pruritis (itching) and bile acids in the blood—two of the telltale signs of hepatic encephalopathy. Patients on the Ocera drug had a lower rate of diarrhea than those on the standard lactulose—29 percent compared to 52 percent, respectively.
Unlike Vertex, which is facing a horde of 40 some drugs chasing its lead in hepatitis C, Ocera faces little competition in the field of mild hepatic encephalopathy, Fischer says. Lactulose is used in severe patients, he says. Raleigh, NC-based Salix Pharmaceuticals (NASDAQ: SLXP) filed an application for FDA approval to sell rifaximin (Xifaxan) for patients with hepatic encephalopathy, and has said it expects the FDA to hold an advisory committee meeting on the drug in February.
Salix has been doing some of the hard work of raising awareness among physicians of the new treatment options, and Fischer sent along a report from Scott Henry of Roth Capital Partners that found that 49 percent of doctors would choose to treat a mild form of the disease with the Salix drug, compared with 37 percent who would stick with lactulose.
Ocera is still a long way from marketing its candidate. It has about 15 employees focusing on the clinical development of AST-120. It is recruiting about 150 patients into a mid-stage clinical trial that is scheduled to produce results by June, Fischer says. This study is designed to show a cognitive improvement after two months of taking the Ocera drug.
The company has enough cash in the bank to operate “into 2011,” Fischer says, so if the data are positive, it shouldn’t run low on cash.
Vertex and others will probably still dominate the headlines at conventions like The Liver Meeting, because hepatitis C affects 3.2 million people in the U.S. alone and millions more worldwide. But Ocera says it is content with following the path less traveled.
“Most companies are focusing on hepatitis C, not the long-term consequences of hepatitis C, which is cirrhosis,” Fischer says. “It’s still an unmet need.”