Anadys Keeps Surging, as Hepatitis C Drug Data Trickles In

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Biotech, Hepatitis C, Life Sciences

Anadys Keeps Surging, as Hepatitis C Drug Data Trickles In

Luke Timmerman 2/10/09

The more data dribbles out of Anadys Pharmaceuticals, the more investors

apparently like what they see. The San Diego-based biotech company said today

that one of its experimental drugs for hepatitis C was effective at killing the

virus in three more patients who took a low dose in a clinical trial, providing

a bit of extra evidence to confirm the results that caused its shares to triple

last month.

Anadys CEO Steve Worland provided the update yesterday in a presentation at the

BIO CEO investor conference in New York. The company’s stock (NASDAQ: ANDS)

climbed 3 percent to $6 at yesterday’s close. It has continued its surge since

Jan. 8, when the company said its ANA-598 drug candidate was able to eliminate

99 percent of the virus from the blood, by itself, within 72 hours among the

first eight patients in a clinical trial.

The study now shows that ANA-598 is producing about the same amount of viral

clearance from the blood with the three additional patients, who got the low

dose of 200 milligrams twice a day, Worland says. The company expects to finish

enrolling patients in the study by the end of this month, and hopes to present

full results at the European Association for the Study of the Liver meeting in

Copenhagen, Denmark, in April. The drug is considered important because it is a

leader in its class of non-nucleoside polymerase inhibitors, and it ought to be

easily combined with some of the 40 new drugs in various stages of clinical or

animal testing across the pharmaceutical industry, Worland says. Anadys believes

its drug is standing out in the subset of drugs in the non-nucleoside class.

“The non-nucleoside class has been a tough nut to crack,” Worland said in the

presentation.

An estimated 170 million people worldwide are infected with hepatitis C virus, a

chronic liver bug that can lead to liver failure. A new generation of various

virus-killing treatments are promising to change the standard treatment of

pegylated interferon and ribavirin, which cures people less than half the time,

and causes nasty flu-like side effects that last for almost a year. Cambridge,

MA-based Vertex Pharmaceuticals is aiming to blaze a new path with a protease

inhibitor drug to improve the cure rate, and shorten treatment. Another class of

nucleoside polymerase inhibitors like one from Pharmasset and Roche are working

their way through clinical development, ahead of Anadys.

Of course, the Anadys candidate is still very early in clinical trials. The

company plans to run another early-stage study this year with healthy volunteers

who will take its drug for 14 days, to get more of a sense of how it is absorbed

in the body, as well as its safety over a longer period of time, Worland says.

Then by mid-2009, the company hopes to start the first mid-stage study of its

drug in combination with standard treatments, to see how well it does at

improving clinical cure rates after the required 24 weeks. That study should

provide an answer in the first half of 2010, Worland said.

But Worland also alluded to the possibility of a partnership in his speech to

investors, since big drugmakers are looking to fill gaps in their portfolios

with intriguing molecules like the one from Anadys. There is some evidence of

Big Pharma interest in the field. Last month, Seattle-based ZymoGenetics signed

a partnership with Bristol-Myers Squibb that’s potentially worth as much as $1.1

billion in milestone payments, to develop a modified interferon drug with fewer

side effects.

Luke Timmerman is the National Biotechnology Editor for Xconomy. You can e-mail

him at ltimmerman@... or call 206-624-2374.