More data is rolling in from Vertex Pharmaceuticals on its lead drug for hepatitis C, and it looks like the medicine is continuing to live up to its own high expectations. The Cambridge, MA-based company said today that telaprevir’s effect on killing the virus is remaining durable on follow-up analysis, and the drug appears to just about as good in a more convenient twice-daily pill form instead of its standard three-times-a-day dosing schedule.

The data dump came in front of a prime audience of physicians attending the American Association for the Study of Liver Disease annual meeting today in San Francisco. The results appear to match up pretty consistently with what Vertex has reported previously, which I wrote about in this advance story.

To recap what’s at stake, telaprevir is aiming to be a first-in-class protease inhibitor against hepatitis C, a chronic liver disease. If it can deliver in the final stage of clinical trials, it will change the standard of treatment for the disease. An estimated 3.2 million people in the U.S. have hepatitis C infections, and about 170 million have it worldwide. Telaprevir must be taken with a pair of standard drugs, pegylated interferon alpha and ribavirin, which cause flu-like symptoms and must be taken for almost a year. The Vertex drug is highly anticipated, though, because it has shown in earlier trials that it can almost double the cure rate for patients when added to standard therapy, and in half the time. If approved, the product could generate $2.6 billion in U.S. sales in 2013, according to Rachel McMinn, an analyst with Cowen & Co. in San Francisco.

“These are strong and striking early results,” says Freda Lewis-Hall, Vertex’s executive vice president for medicines development.

In the spirit of helping you keep all this data straight, because there’s a lot of it, we’re breaking this down into bite-size chunks. .

—The ‘107 study. This trial of patients who didn’t respond to previous treatment, produced data from more patients who were followed over a longer period than was previously reported. Researchers found that 68 of 104 patients, or about two-thirds, who got telaprevir along with standard drugs had no evidence of the virus in their blood after four weeks. That effectiveness appeared to be long-lasting. Researchers found that 41 of 71 patients (58 percent) followed for 24 weeks still had no evidence of the virus in the blood. Importantly, telaprevir is showing that it can wipe out the virus about 43 percent of the time in the toughest patients of all to treat—those who didn’t respond at all to a prior round of therapy.

The last time Vertex reported results from this trial, at a European meeting in April, it didn’t have any follow-up data that extended this long, or such strong data for what are called “null responder” patients. Of course, there were side effects, though. About 8 percent of patients dropped out of the study because of adverse events, with about half of them quitting because they developed a rash, the company said.

—The C208 study. This trial is about convenience for patients. …Next Page »

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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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