Anadys, L.G. Life Sciences report significant viral load reduction using ANA380 in trials

By Elaine Rigoli

Tampa, Fla., Feb. 14 - Anadys Pharmaceuticals, Inc. and L.G. Life Sciences, Ltd. announced Tuesday the principal findings from a dose-escalation phase II clinical trial, evaluating the safety and antiviral activity of ANA380 (LB80380) in patients with lamivudine-resistant hepatitis B virus infection.

These findings are based on an analysis of data from 12 weeks of dosing in 59 patients with lamivudine-resistant hepatitis B. Each of the patients in the study had been previously treated with lamivudine, the current standard of care for hepatitis B patients, and was documented to have genetically encoded lamivudine resistance. In this phase 2 clinical 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 hepatitis B DNA of 3.8 to 4.0 log10 units (greater than 99.9% clearance of the virus in plasma) at week 12, according to the release.

"We are delighted by ANA380's promising clinical results and believe that these results highlight the potential for ANA380 to be the next generation therapy for HBV [hepatitis B] patients. We are eager to move forward with Anadys to plan the next stages of clinical development," said In-Chull Kim, PhD, president and chief executive officer of LG Life Sciences, in a company statement.

The development of viruses resistant to direct antiviral therapies (i.e. lamivudine resistance) is a growing problem in hepatitis B-infected patients due to the virus' ability to mutate rapidly.

According to the World Health Organization, 350 to 400 million people are chronically infected, and approximately 1 million people die each year from chronic hepatitis B or related conditions. The current annual market for hepatitis B therapy is approximately $500 million and is expected to grow to more than $1 billion by 2009, according to the release.

Based in San Diego, Anadys Pharmaceuticals is a biopharmaceutical company that develops small molecule medicines for the treatment of hepatitis, other serious infections and cancer. LG Life Sciences is a pharmaceutical company in Seoul, South Korea that develops products to fight various infectious diseases, diabetes and other chronic illnesses.

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