Anadys Drug Found Safe in Small Study, Aims to Contend in New Class of Hepatitis C Meds

11/1/08Follow @xconomy

Anadys Pharmaceuticals may not be first in a new class of emerging drugs for hepatitis C, but it’s aiming to show this weekend it’s a contender. The San Diego-based company is reporting today that its lead drug candidate was found safe at a variety of doses in a clinical trial of 48 healthy volunteers, and appears to have potential to be given as a once-daily or twice-daily pill.

San Diego-based Anadys (NASDAQ: ANDS) reported results on ANA598 at the American Association for the Study of Liver Disease meeting today in San Francisco. The company (pronounced Uh-nad-iss), found its drug appeared to be highly potent against the virus at the second-lowest dose tested, and that no serious side effects were reported among any patients, whether they took 400 milligrams, 3000 milligrams, or anything between, researchers said at the liver meeting.

“We’re comfortable predicting that we’re going to have an antiviral effect,” said CEO Steve Worland. “This puts our stake in the ground.”

This safety data is important to Anadys. Its stock was cut in half on June 26, 2006 after one of its other candidates, ANA975, was found to cause “intense immune stimulation” in animals. That drug was scrapped a year later when another animal study confirmed the unwanted effect, which caused a partnership with the drug giant Novartis to unravel.

Now Anadys is taking a new approach with ANA598, a polymerase inhibitor drugs against hepatitis C. These drugs could be added in combination treatments with protease inhibitor drug candidates now in later stages of development from Vertex Pharmaceuticals and Schering-Plough. They’re all chasing a big market opportunity, with 3.2 million people in the U.S. infected with hepatitis C, and an estimated 170 million worldwide.

The Anadys drug is going up against some tough players in its quest to develop a polymerase inhibitor for hepatitis C, namely Gilead Sciences (NASDAQ: GILD) and a partnership between Roche and Pharmasset. Those companies are further along in development than Anadys, Worland says, plus Abbott Laboratories and Pfizer are working in the field at earlier stages. They are drawn to this class of polymerase inhibitors because doctors see potential for them to add punch to protease inhibitors, since the different drugs attack different parts of the virus, Worland says.

“What people want is to use more than one antiviral in combination with each other. It’s building on the HIV paradigm,” Worland says.

The data from Anadys and its competitors is being watched carefully by the bigger players in heptatis C treatment. … Next Page »

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