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HCV NNRTI ANA598 News Update: Anadys Keeps Surging,
as Hepatitis C Drug Data Trickles In
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Luke Timmerman 2/10/09
http://www.xconomy.com
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.
Hepatitis C Drug From Anadys Shows Quick Virus-Killing Punch
Luke Timmerman 1/8/09
An early peek at data from Anadys Pharmaceuticals (NASDAQ: ANDS) suggests the company may have a promising new drug in the works for hepatitis C. The San Diego-based biotech is announcing results today from the first eight patients with the chronic liver infection, which shows its drug has more viral killing pop in the first three days of treatment than was seen in other drugs studied in its class, with minimal side effects.
The company found that its experimental medicine was able to wipe out 99 percent of the virus from the blood (known as a 2.5 logarithmic reduction) within 72 hours at the lowest dose tested in a Phase I clinical trial, says CEO Steve Worland. This finding was in the first group of patients who took a 200 milligram, twice-daily dose of ANA598. It is just the first slice of data available, and the trial is continuing to enroll patients at two higher doses, Worland says. The company hopes to present full data at the European Association for the Study of the Liver meeting in Copenhagen, Denmark in April.
Today's news will at least give Worland a fresh talking point next week when he meets with a bunch of bummed-out investors at the JP Morgan Healthcare Conference in San Francisco. Worland will try to cheer them up by arguing his company's drug is looking better at this early stage of development than others in its class from Gilead Sciences (NASDAQ: GILD) and Pfizer (NYSE: PFE). Drugs in this class-non-nucleoside polymerase inhibitors-aim to be fast followers in the race to improve treatment for patients with hepatitis C, behind a group of protease inhibitor meds.
Most researchers' attention is now focused on a different class, protease inhibitors like ones from Vertex Pharmaceuticals and Schering-Plough, as well as nucleoside polymerase inhibitors like ones from Pharmasset and Roche. Since the hepatitis C virus is a chronic infection, like HIV, many scientists believe a cocktail of therapies with different viral killing mechanisms is the best way to keep it in check.
"This way you can attack the virus from multiple angles," Worland says.
Anadys (Uh-nad-iss) showed its drug appeared safe in 48 healthy volunteers, at a variety of doses back in November. But of course, it still has a long way to go. The company's plan is to move later this year to a mid-stage clinical trial, which looks at its drug in combination with pegylated interferon alpha and ribavirin, the standard anti-viral course. It's possible Anadys could enroll as many as 100 patients in that trial, and design it to analyze effectiveness for 24 or 48 weeks, although the protocol hasn't been finalized, Worland says. The company is also doing long-term toxicity studies in animals, and working on scaling up manufacturing, he says.
The FDA typically requires companies to first show an ability to quickly wipe out the virus in the first three days, like the study being announced today, before companies can move on to more rigorous long-term follow-up studies, Worland says. Anadys plans to hold a conference call with analysts today at 8:30 am Eastern time to discuss the findings and answer questions about what comes next.
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