Human Genome Sciences, Inc. () today announced interim results through Week 12 following the end of treatment in a Phase 2b clinical trial conducted by Novartis to evaluate the safety and efficacy of ZALBIN™ (albinterferon alfa-2b), an investigational agent, administered monthly in combination with ribavirin in 391 treatment-naive patients with genotypes 2 and 3 chronic hepatitis C virus. The primary efficacy endpoint is sustained virologic response (SVR) at Week 48 (24 weeks following the end of treatment).
“These interim results may suggest that the efficacy of 1500-mcg albinterferon alfa-2b dosed every four weeks is comparable to the current standard of 180-mcg peginterferon alfa-2a dosed once weekly,” said Stephen Pianko, M.D., F.R.A.C.P., Ph.D., Monash University, Melbourne, Australia. “The results of this study in patients infected with genotypes 2 and 3 hepatitis C support continued evaluation of albinterferon alfa-2b dosed every four weeks in a larger Phase 3 program.”
Sustained virologic response rates at Week 12 (SVR12) following the end of treatment were 81% for the treatment group receiving 1500-mcg albinterferon alfa-2b dosed once every four weeks (q4w), vs. 82% for the treatment group receiving peginterferon alfa-2a (Pegasys) at the standard 180-mcg dose once every week. SVR12 rates were 76% and 75%, respectively, for the 900-mcg q4w and 1200-mcg q4w albinterferon alfa-2b treatment groups.
Overall, the adverse event profile was generally comparable for q4w albinterferon alfa-2b compared with q1w peginterferon alfa-2a. Serious adverse events during treatment in the albinterferon alfa-2b treatment groups were 4% for 900-mcg, 3% for 1200-mcg, and 3% for 1500-mcg, compared with 4% for peginterferon alfa-2a. Rates of discontinuations due to adverse events were: 1% for 900-mcg, 3% for 1200-mcg, 4% for 1500-mcg, and 1% for peginterferon alfa-2a. No increase in serious or severe respiratory events was observed in any albinterferon alfa-2b arm compared to peginterferon alfa-2a. Hematologic reductions were significantly lower in all albinterferon alfa-2b treatment groups.
“With a total requirement of six injections over a 24-week course of treatment, the albinterferon alfa-2b monthly dosing regimen has the potential to offer an important option for the combination treatment of patients infected with genotypes 2 and 3 hepatitis C,” said Mani Subramanian, M.D., Ph.D., Executive Director, Clinical Research - Infectious Diseases, HGS. “We look forward to the full presentation of final results from the current study at an appropriate scientific meeting later in 2010.”
ZALBIN (also known as JOULFERON® outside the U.S.) is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in 2006. The two companies have successfully completed Phase 3 development of ZALBIN dosed every two weeks. HGS has submitted a Biologics License Application (BLA) to the FDA in the United States for ZALBIN dosed every two weeks and has received confirmation that its submission was accepted for filing with a PDUFA target date of October 4, 2010. Novartis has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) in Europe for the same dosing regimen under the brand name JOULFERON®.
About the Design of the Phase 2b Monthly Dosing Trial
This Phase 2b trial is a randomized, open-label, multi-center, active-controlled, dose-ranging study to evaluate the safety and efficacy of albinterferon alfa-2b administered every four weeks plus daily ribavirin in treatment-naïve patients with genotypes 2 and 3 chronic hepatitis C. 391 patients were randomized in a 4:4:4:3 ratio into four treatment groups, including three that received albinterferon alfa-2b administered once every four weeks (900 mcg, 1200 mcg or 1500 mcg), in addition to the active-control group, which received peginterferon alfa-2a at the standard 180-mcg dose once every week. All patients in the study received 800-mg daily oral ribavirin. The total duration of treatment was 24 weeks. The primary efficacy endpoint is sustained virologic response (SVR) at Week 48 (24 weeks following the end of treatment).
About the Collaboration with Novartis
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