Anadys reports encouraging hepatitis trial results

Results of the clinical trial, which investigated the safety, tolerability and anti-viral activity of ANA380, an oral prodrug of ANA317 (LB80317), in patients with lamivudine-resistant hepatitis B virus (HBV), are based on an analysis of data in 62 patients in five cohorts.

Cohorts received ANA380 in escalating doses of 30mg, 60mg, 90mg, 150mg or 240mg once daily by oral administration for 12 weeks. Patients in each cohort had been previously treated with lamivudine, the current standard of care for HBV patients, and were documented to have genetically-encoded lamivudine resistance.

Patients treated with ANA380 at 90mg, 150mg and 240mg 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, (greater than 99.9% clearance of the virus in plasma).

Patients treated with ANA380 at 30mg and 60mg dose levels experienced comparable reduction in plasma HBV viral DNA at 12 weeks of 2.8 log10 units and 3.2 log10 units, respectively.

Furthermore, patients experienced substantial reduction in levels of alanine aminotransferase (ALT), a commonly used marker of hepatocyte injury, which typically indicates a reduction in inflammation associated with HBV infection.

Based on these data, proposed phase IIb clinical trials are expected to focus on dose ranges around the 90mg to 150mg dose levels.

In addition to its activity against lamivudine-resistant HBV, ANA380 in preclinical studies has recently demonstrated potent activity against both wild-type and resistant viral strains.

“These phase II data are significant and very encouraging, and suggest that ANA380 may very well be the best-in-class among marketed HBV therapies and product candidates in development,” said Dr Kleanthis Xanthopoulos, president and CEO of Anadys. “We and our LG Life Sciences partner look forward to both the next clinical milestones and advancing our business discussions with Novartis on this program.”