[Hep B, Anadys]
Anadys Pharmaceuticals and LG Life Sciences Announce Completion of Phase I/IIa Clinical Trial of ANA380 -LB80380- in Patients Chronically Infected with Hepatitis B Virus
Tuesday May 11, 7:00 am ET
Results indicated ANA380 was well tolerated with significant hepatitis B viral suppression
SAN DIEGO & SEOUL, Korea--(BUSINESS WIRE)--May 11, 2004-- Anadys Pharmaceuticals, Inc. (Nasdaq:ANDS - News) and LG Life Sciences, Ltd. (KOSPI:68870) of Seoul, Korea today announce summary results from a completed Phase I/IIa, double-blind randomized, placebo-controlled dose escalation clinical trial of ANA380 (LB80380). Key findings from this study were reported at the 39th annual meeting for the European Association for the Study of the Liver (EASL) held in Berlin, Germany. The data demonstrated that oral administration of the compound over 28 days both was well tolerated and reduced HBV viral load by up to 4.0 log10 units, or by 99.99%, in the chronic hepatitis B virus (HBV) infected patients treated in the study.
In this clinical study, four cohorts comprised of seven patients each received either placebo or ANA380 (LB80380) once daily for 28 days. The doses used were 30mg, 60mg, 120mg, and 240mg, which were administered through a dose escalation process. Following completion of dosing, patients were followed for a median of 8.9 weeks. The viral load returned to pretreatment levels during the follow-up period, indicating that the viral load decline was likely associated with treatment. Anadys and LG Life Sciences are encouraged by these results, which indicated that ANA380 (LB80380) was well tolerated and caused significant suppression of hepatitis B virus.
About ANA380 (LB80380)
ANA380 (LB80380) is a nucleotide analog currently in Phase II clinical trials for the treatment of chronic HBV infection. The compound has exhibited activity in vitro against both HBV typically found in untreated patients and also HBV variants that demonstrate resistance to treatment with the nucleoside analog lamivudine, which is a currently commercialized therapy for HBV. Preclinical studies in animals have demonstrated significant activity against HBV, low potential for drug interactions and good safety and tolerability in a range of toxicology studies. |
