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ANA380 Exhibits Activity In Vitro Against Multiple Clinically,Relevant Hepatitis B Virus Mutants

it is possible that ANA380/LB80380 used in combination with these existing drugs may help prevent the emergence of resistance. These new results are also consistent with previously reported clinical data showing that ANA380 is active in patients refractory to lamivudine."

"Clearly, we are encouraged by these study results and believe they support additional clinical evaluation to confirm the potential broad clinical utility of ANA380 in treating patients with chronic HBV infection," said In-Chull Kim, Ph.D., President and Chief Executive Officer of LG Life Sciences.

Anadys and LG Life Sciences entered into a Joint Development and License Agreement in April 2004 providing for the global development of ANA380 and pursuant to which Anadys acquired commercialization rights to ANA380 in North America, Europe, Japan and the rest of the world other than China, Korea, India and countries in Southeast Asia. Next steps for the program, including a proposed Phase IIb dose selection clinical trial, are under discussion between Anadys and LGLS.

Study Methods

HBV mutant strains were generated from a wild-type strain of HBV genotype D through site-directed mutagenesis. Mutant strains encoded polymerases resistant to lamivudine, adefovir, entecavir or telbivudine. Replicate HepG2 cell cultures were infected with HBV DNA using baculovirus vectors and were exposed to different concentrations of each drug for seven days. Viral DNA then was extracted and quantified. EC50 values, which were calculated from averages of three independent experiments, were used to evaluate susceptibility.

Clinical Background

ANA380 is an oral prodrug of ANA317 (LB80317), a nucleotide analog. Data from 62 HBV infected patients from a previous Phase II study showed that patients treated daily with ANA380 at 90 mg, 150 mg and 240 mg dose levels experienced reduction in plasma HBV viral DNA at 12 weeks of 3.9 log10, 3.9 log10 and 4.1 log10 units, respectively, (greate
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