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www.fdanews.com/articles/84594-anadys-and-l-g-life-sciences-report-hbv-study-data

ANADYS AND L.G. LIFE SCIENCES REPORT HBV STUDY DATA

February 15, 2006

Anadys Pharmaceuticals and L.G. Life Sciences have announced principal findings from an open-label, multicenter, dose-escalation Phase II clinical trial, evaluating the safety and antiviral activity of ANA380 (LB80380) in patients with lamivudine-resistant hepatitis B virus (HBV) infection.

The findings are based on an analysis of data from 12 weeks of dosing in 59 patients with lamivudine-resistant HBV. Each of the patients in the study had been previously treated with lamivudine, the current standard of care for HBV patients, and was documented to have genetically-encoded lamivudine resistance. In the study, each of the patients was enrolled in one of five cohorts and received either 30 mg, 60 mg, 90 mg, 150 mg, or 240 mg of ANA380 once daily by oral administration for the 12 weeks of the study.

Patients receiving either 90 mg, 150 mg or 240 mg of ANA380 achieved robust viral load reductions in serum HBV DNA of 3.8 to 4.0 log10 units (greater than 99.9 percent clearance of the virus in plasma) at week 12. In addition to the significant viral load reduction observed, the levels of alanine aminotransferase (ALT) were also substantially reduced. A decline in ALT levels, a commonly used marker of hepatocyte injury, typically indicates a reduction in inflammation associated with HBV infection.