The ongoing clinical trial is an open label, multi-center, sequential group dose escalation study designed to assess the safety and antiviral activity of ANA380 in chronically infected HBV patients who are resistant to lamivudine.
In the study, oral administration of ANA380 (LB80380) over 12 weeks reduced DNA viral load by an average of 3.9 log10 units, or more than 99.9%, in lamivudine-resistant patients receiving 90mg doses in the study. Patients receiving 60mg and 30mg doses showed an average viral load reduction of 3.2 log10 and 2.8 log10 units, respectively.
The data also demonstrated that ANA380 was well tolerated and safe at all doses studied, although Anadys cautioned that definitive conclusions regarding product safety cannot be made until the results of future clinical trials of longer duration in more patients are known.