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Ocera Tests Drug to Treat Little-Known Condition

Serial entrepreneur Eckard Weber has spent years picking through promising pharmaceutical compounds that originated in Asia but, for one reason or another, were shelved by drug makers or used for treating only certain illnesses.

Ocera Therapeutics Inc., a San Diego biotech Weber helped co-found five years ago, is testing one of those for a little-known neuropsychiatric condition called mild hepatic encephalopathy.

The condition, caused by the liver’s inability to break down toxins causing a buildup in the brain, is estimated to affect as many as 60 percent of the 1 million Americans living with liver cirrhosis, the kind of scarring often caused by hepatitis C viral infections that can lead to liver failure. The condition can be tough to diagnose, but symptoms often involve difficulty balancing or driving a car, along with other cognitive impairments.

“It’s a widespread problem,” Weber said. “There are really no treatments available for it, so there is a very great need for a new medication.”

Ocera, a 15-employee “virtual” company that outsources much of its clinical work, said Feb. 23 that it will study its drug on 150 people in an eight-week trial known as ASTUTE to determine whether it can effectively improve brain function. The data is expected in mid-2010.

Ocera’s drug, known as AST-120, works like a sponge to soak up the toxins in the gastrointestinal tract before they can work their way up to the brain and impair brain function.

New Application For Drug

Weber said he was in the market for a gastrointestinal treatment for some time, and in 2005, Japanese specialty chemicals and plastics company Kureha Corp. agreed to license the compound to Ocera.

Marketed in Japan under the name Kremezin, the drug had been used for years in treating end-stage renal disease, but Weber said anecdotal evidence also showed its anti-inflammatory effects were good for treating gastrointestinal problems such as irritable bowel syndrome.

“I knew it was in the market in Japan for renal failure and there were also indications it might have some application in GI diseases,” he said. “It didn’t have a label for (GI) in Japan.”

Since then, five-year-old Ocera has amassed a slew of investments — $62 million altogether from venture capital firms such as Weber’s Domain Associates L.L.C., Sofinnova Ventures Inc., InterWest Partners LLC and Thomas McNerney & Partners.

If all goes well, the drug maker could reach the point of late-stage Phase 3 trials for mild hepatic encephalopathy by the end of the year. CEO Laurent Fischer said the company could eventually position the drug to treat more serious forms of the condition, putting it in direct competition with Salix Pharmaceuticals Inc. of North Carolina. Fischer said Ocera’s drug would have the advantage over an antibiotic because long-term antibiotic use has been associated with hard-to-treat infections such as Clostridium difficile, a diarrhea-causing “super-bug.”

Good News

Fischer said the company felt especially validated in its work when Salix received welcome news from the U.S. Food and Drug Administration on Feb. 23 — its Xifaxan antibiotic was recommended for approval by an FDA panel. The FDA typically, but not always, approves drugs recommended by its panel, so the nod meant that its drug could make it past the final regulatory benchmark before commercialization.

“I think it is great news because it clearly indicates the fact that the agency recognizes this as an important indication,” Fischer said.

If Ocera’s drug is approved for the milder version of hepatic encephalopathy, Fischer said, the company intends to build its own sales force of approximately 150 to sell to gastrointestinal specialists. It would rely on a bigger partner, he said, to tackle the larger primary care markets.

“We’re exploring a number of potential partnerships,” he said.

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