OctoPlus N.V, the drug delivery and development company, has announced the successful completion of the phase IIa clinical study with its lead product Locteron, a controlled release interferon alfa product for the treatment of chronic hepatitis C (HCV).
Results from this study confirm Locteron's potential to substantially improve patient care in HCV. Safety data from the study show a substantially improved tolerability profile for Locteron compared to other interferon products on the market or in development. Efficacy data from the study indicate Locteron's strong antiviral effect, with 100 per cent of the patients achieving early virologic response in the two highest dose groups. In addition, Locteron is a more convenient therapy than existing treatments due to its controlled-release profile, allowing for once every two weeks drug administration versus the current once a week regimen. OctoPlus is co-developing Locteron with its partner Biolex Therapeutics.
"We are excited that the results of this study demonstrate Locteron's potential for a convenient, safe and efficacious hepatitis C therapy with less side effects than its competing products. In addition, we believe that the emergence of new oral antiviral products, which are associated with additional side effects, will further add to the opportunity for Locteron to be the interferon of choice for future combination therapy as a result of its potential for improved tolerability. We are on schedule to proceed with the development plan for Locteron and are preparing to commence a phase IIb clinical study in the first half of 2008," said, Joost Holthuis, CEO, OctoPlus
The dose response in antiviral effect that was observed in the first three dose cohorts continued in the final cohort: average viral reduction after 12 weeks of treatment was greater than 4 logs for the 320 microgram (ug), 480 ug and 640 ug dose cohorts, and 1.8 logs for the 160 ug dose.
The early virologic response (EVR, defined as at least a two-log reduction in hepatitis C virus after 12 weeks of treatment) that was observed in the first three dose cohorts, also continued in the final cohort: the percentage of patients who achieved this was 38% for the 160 ug dose, 88 per cent for the 320 ug dose, and 100 per cent for both the 480 and 640 ug doses. These results compare favorably with results for the currently marketed pegylated interferon alfa products and for Albuferon for which EVR rates ranging from approximately 74 per cent to 90 per cent in clinical trials have been reported.
Complete and final results of the study, including viral kinetics and pharmacokinetic results, will be presented at the Annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, USA, on November 6.
Locteron is designed to be a best-in-class therapeutic for patients with chronic hepatitis C, with the potential to induce less side effects, improve patient compliance and provide a more convenient once every two week dosing schedule compared with current therapies.
OctoPlus N.V. is a product-oriented biopharmaceutical company committed to the creation of improved pharmaceutical products that are based on OctoPlus' proprietary drug delivery technologies and have fewer side effects, improved patient convenience and a better efficacy/safety balance than existing therapies.