Data Being Presented Today at 44th Annual Meeting of EASL
Management to Discuss Study Results and Program Status During Q1 Financial Results Call at 5 P.M. EDT Today
SAN DIEGO, April 23 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) today announced that ANA598, the Company's investigational non-nucleoside polymerase inhibitor, demonstrated potent antiviral activity at all dose levels and was well tolerated in a Phase Ib study in which patients chronically infected with the Hepatitis C virus (HCV) were treated for three days. The results from the recently completed study are being presented today during the late-breaker poster session at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL) in Copenhagen, Denmark.
In the study, ANA598 treatment resulted in rapid and sustained reductions in HCV RNA with median reductions at end of treatment (Day 4) exceeding 2 log10 (>99%) at all dose levels. At 200 mg bid (twice-daily), the median viral load reduction was 2.4 log10 (range of 0.4 to 3.4); at 400 mg bid, 2.3 log10 (range of 1.6 to 3.5); and at 800 mg bid, 2.9 log10 (range of 2.2 to 3.4). Genotype 1a patients demonstrated median reductions of 1.4 log10, 1.8 log10, and 2.5 log10 at 200, 400 and 800 mg bid, respectively. In 10 of the 12 genotype 1a patients who received ANA598, viral load was still declining at the end of the three days of treatment. Genotype 1b patients demonstrated median reductions of 2.6 log10, 2.5 log10, and 3.2 log10, at 200, 400 and 800 mg bid, respectively. No patient showed evidence of viral rebound while on ANA598. ANA598 was well-tolerated in this short term study and there were no serious adverse events.
Steve Worland, Ph.D., Anadys' President and CEO, commented that 'The potent antiviral activity demonstrated at all three doses in this study is very encouraging for the prospects of ANA598 when used in combination with other HCV agents. With the successful conclusion of this study in patients and the 14-day study in healthy volunteers, the positive 13-week animal toxicology results and ongoing manufacturing activities, the ANA598 program continues on track to be ready for Phase II in mid-2009.'
The Phase Ib study was a randomized, double-blind, placebo-controlled, multiple ascending dose trial conducted to evaluate the safety, tolerability and antiviral activity of orally administered ANA598 in treatment-naive patients with chronic HCV genotype 1 infection. Patients were treated with ANA598 capsules (or matching placebo) at doses of 200 mg, 400 mg or 800 mg bid for three days. 35 patients participated in the study, with 11 receiving 200 mg bid, eight receiving 400 mg bid, eight receiving 800 mg bid and eight receiving placebo (with none of the patients receiving placebo showing an end of treatment response greater than 0.2 log10 reduction in viral load). Viral load at Day 4 (12 hours after the last dose) was compared to baseline HCV RNA levels.
'We're very pleased with the antiviral activity and safety of ANA598 in this study,' commented James Freddo, M.D., Senior Vice President, Drug Development and Chief Medical Officer. 'We believe the data continue to position ANA598 as a leading non-nucleoside polymerase inhibitor in development for the treatment of HCV, and we look forward to investigating ANA598 in longer-term studies in combination with current standard of care.'
ANA598 Program Update
Anadys continues to make progress on all aspects of the ANA598 program, including toxicology, manufacturing and a recently completed 14-day clinical study in healthy volunteers. The Company reiterates its expectation for the program to be ready mid-year for the first Phase II study of ANA598 in combination with pegylated interferon and ribavirin. The actual timing for the initiation of Phase II studies may depend on a number of factors, including FDA review timelines, the timing of any potential transaction around ANA598 or ANA773, available cash resources and funding activities, and the engagement of clinical sites.
14 Day Healthy Volunteer Study
Anadys recently completed dosing healthy volunteers in a 14-day study conducted to extend the safety and pharmacokinetic profile of ANA598. Thirty subjects participated in the study, with eight subjects receiving ANA598 and two subjects receiving placebo at each dose level (400 mg once-daily, 800 mg once-daily and 600 mg bid). Subjects received ANA598 or placebo on day one followed by pharmacokinetic assessment over days two and three and received subsequent doses consecutively on days four through fourteen.
