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. Vertex’s chief commercial officer, Kurt Graves, told me his company is looking at emerging polymerase inhibitors, and NS5A inhibitors, which might someday offer patients a chance to get rid of a standard combination treatment they must take, of pegylated interferon alpha and ribavirin. Those drugs must be taken for almost a year; cause serious flu-like symptoms that make them difficult to tolerate, and only cure the virus for about one-third of patients.
The Anadys data, while still at an early stage, suggests it could be used in combinations, Worland says. Anadys saw in this Phase Ia trial that patients who took an 800 milligram dose of its drug twice-daily were able to get almost five times the amount of drug needed in the bloodstream to wipe out the virus. The drug, however, wasn’t given to actual hepatitis C patients. The next step, which the company announced earlier in the week, is to recruit 30 hepatitis C patients for another study that will look at the drug’s safety. That study also will look at early indications of its virus-killing ability at 200 milligrams, 400 milligrams, and 800 milligrams twice a day, the company has said. Data from this trial will be available in the first quarter of 2009, Worland says.
Since it’s been gaining confidence from its clinical trial results, Anadys is going to continue carrying on partnership talks with a number of companies that are interested in combining treatments, Worland says. To add some complexity to the discussions, Anadys has another drug candidate for hepatitis C, ANA773, which is designed to stimulate the body to produce interferon proteins. That could be used in combination with any number of antivirals, and could replace the standard pegylated interferon alpha, Worland says.
The market for hepatitis C drugs may grow to $8 billion in 2015, according to analyst Brian McCarthy with Merriman Curhan Ford & Co., in a note to clients earlier this year. Anadys isn’t saying when it thinks it get its first drug on the market, but if it can grab even a fraction of that kind of cash, then it will be on its way to becoming one of the bigger biotechs in San Diego. It’s still pretty early to handicap this race, though. “This is a complex poker game, with new cards being turned over every round,” Worland says.