San Diego-based Anadys Pharmaceuticals generated a ton of buzz almost four months ago when it offered an early peek at data suggesting its hepatitis C drug might be working, and now a presentation of the full data appears to reinforce the first impression.
Anadys’ lead drug candidate, ANA598, was able to wipe out more than 99 percent of the hepatitis C virus at all three doses tested in a trial of 35 patients, according to data presented today at the European Association for the Study of the Liver meeting in Copenhagen, Denmark. No patients had any serious side effects, and none showed signs of developing resistance to the drug or having their virus bounce back while taking the pill twice-daily over three days.
“The potent antiviral activity demonstrated at all three doses in this study is very encouraging for the prospects of ANA598 when used in combination with other HCV agents,” said Anadys CEO Steve Worland, in a statement. Hepatitis C is an infection of the liver caused by virus.
Anadys has been on a roll since January, when the company offered an initial peek at data that said ANA598 was working in the first cohort of patients who got the lowest dose, 200 milligrams twice a day. Investors are jazzed about this research, causing Anadys stock (NASDAQ: ANDS) to more than double since then. That’s because more than 170 million people worldwide have hepatitis C infections, and Anadys is part of a burgeoning wave of innovation in the biotech industry to treat this liver-damaging disease. More than 40 different drugs are in development, and they are likely to be used in HIV-style cocktail treatments to prevent the virus from developing resistance, Worland told me last month.
Cambridge, MA-based Vertex Pharmaceuticals is leading the way with its protease inhibitor, while other companies are developing nucleoside polymerase inhibitors. Non-nucleoside polymerase inhibitors like ANA598 ought to attack the virus from different angles and keep it in check, Worland says.
Investors are hoping Anadys can parlay this new clinical data into a valuable partnership or acquisition. Vertex, for example, paid more than $375 million to acquire ViroChem Pharma so that it could develop novel combination therapies for hepatitis C. At the time, ViroChem had reported its drug showed a highly potent effect in just the first five patients tested.
Anadys hasn’t scored a partnership yet, although it says the new data is encouraging enough to move ahead with a mid-stage clinical trial program. That trial is expected to start in mid-2009, although Anadys said the timing may depend on whether the FDA signs off fast enough and the company has enough money. In that trial, ANA598 will be used in combination with the standard drugs, pegylated interferon alpha and ribavirin.
There’s also a potential fly in the ointment, which Anadys mentioned in its press release.
A separate study of healthy volunteers showed that three people on the drug developed moderate rashes and quit taking the drug after six or seven days, the company said.
For those interested in the actual data, take a deep breath and get ready to absorb some statistics. The drug was able to achieve a 2.4 median logarithmic reduction of the virus in the blood at the lowest dose, 200 milligrams twice a day. At the middle dose, 400 milligrams, the reduction was 2.3 logarithms, and at the highest dose, it was 2.9.
Future trials will need to show the Anadys drug works in combination with the standard treatments, and that it can sustain the viral killing effect for at least 24 weeks after treatment, when patients are considered cured.
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