12:00 AM
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May 04, 2009
 |  BioCentury  |  Product Development

Palm needs Alms

To continue development of lead compound ANA598, Anadys Pharmaceuticals Inc. will have to convince potential partners and investors that the efficacy data from a Phase Ib monotherapy trial are promising enough to outweigh concerns raised by a rash observed in healthy volunteers. The company believes the rash will prove manageable and that ANA598 could outperform its competitors as part of an HCV cocktail, but it doesn't have enough cash to complete a new trial.

Though the data were good, the Phase Ib study presented at the European Association for the Study of the Liver meeting in Copenhagen last month did not put the non-nucleoside NS5B polymerase inhibitor at the head of its class. In the placebo-controlled trial in 35 treatment-naïve patients, monotherapy with ANA598 given as twice-daily doses of 200, 400 and 800 mg produced median viral load reductions of 2.4 log10, 2.3 log10 and 2.9 log10 IU/mL, respectively.

For comparison, Vertex Pharmaceuticals Inc. appears to have the best monotherapy data for an NS5B inhibitor in treatment-naïve patients so far. In a Phase I trial in five patients, 750 mg VCH-222 dosed twice daily resulted in a median viral load decrease of 3.7 log10 IU/mL after three days. Vertex acquired the compound in March when it bought ViRochem Pharma Inc. (see "NS5B Inhibitor Landscape").

ANA598's overall efficacy appeared to be driven by a subset of patients infected with HCV genotype 1b, which accounts for about 40% of HCV infection in the U.S. and Europe. In patients with genotype 1b, the low, middle and high doses of ANA598 resulted in median viral load reductions of 2.6 log10, 2.5 log10 and 3.2 log10 IU/mL. In patients with genotype 1a - which account for the...

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