Locteron, a controlled-release interferon alpha 2b, is designed to improve patient care by providing a more convenient once-every-two week dosing schedule and by reducing the flu-like symptoms associated with pegylated interferons, the current standard of care.
In the Empower study, the 480ug dose of Locteron demonstrated viral kinetics and response rates that were comparable to the PEG-Intron control while also achieving a 57% reduction in flu-like adverse events.
The objective of the Empower study was to test the hypothesis that the 480ug dose of Locteron dosed once every two weeks reduces flu-like symptoms but retains equivalent efficacy compared to PEG-Intron (1.5ug/kg, administered every week).
Reportedly, the 133 patients in the Empower study were enrolled in two contributing Phase 2b trials: Select-2 and 480 Study.
All patients were treatment-naive-genotype-1 subjects with chronic hepatitis C, and all patients were also treated with weight-based ribavirin. A total of 30 sites participated in the two trials (14 sites in the US, 11 in Europe, and five in Israel). All patients in Empower have completed at least six weeks of study, and over 80% of the patients have completed 12 weeks of study.
Through six weeks of treatment, Locteron 480ug administered once every two weeks demonstrated reductions in viral loads (mean changes in HCV RNA from baseline) that were somewhat more rapid than that achieved with PEG-Intron administered once per week.
Rates of undetectable HCV RNA achieved after six weeks of treatment were 31% for Locteron 480ug and 19% for PEG-Intron. The currently available results after 12 weeks of treatment (a number of patients have not yet reached the 12-week time point) suggest comparable reductions in mean HCV RNA and rates of undetectable HCV RNA for Locteron 480ug and PEG-Intron.
Walker Long, chief medical officer and vice president of drug development at Biolex Therapeutics, said: “The Empower study allows us to focus on the activity associated with one specific dose of Locteron and test our hypothesis that equivalent efficacy can be achieved while greatly reducing flu-like adverse events.
“These results exceed our expectations. We believe that the importance of reducing flu-like adverse events will grow with the advent of direct-acting virals and the shortening of therapy, due to the prevalence of these side effects during the first three months of treatment.”