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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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