Medivir has commenced a Phase 1 clinical trial of its investigational drug, MIV-711, designed for the treatment of bone disorders characterised by excessive bone resorption, such as osteoporosis, osteoarthritis and bone metastases.
MIV-711 is a potent and selective reversible inhibitor of cathepsin K, a protease essential for bone destruction, and is now being developed as a new therapy in disease states where a reduction in cathepsin K activity will be beneficial.
In the Phase 1 human study, healthy volunteers will be administered MIV-711 as single ascending oral doses, followed by repeated once daily doses for seven days, in order to examine safety, tolerability and pharmacokinetics.
Medivir CEO Maris Hartmanis said the first human study of the company’s MIV-711 is an important step in its effort to develop new treatment options for patients with bone related diseases.
"The study will provide us with crucial biomarker information, reflecting both bone and cartilage turnover," Hartmanis added.
"Based on this data we will be able to make a fast and informed decision regarding the continued development of MIV-711 to the market."
The study design will allow Medivir to demonstrate how MIV-711 affects biomarkers known to be relevant for measuring bone and cartilage turnover, as well as providing the company with valuable information regarding potential therapeutic dose levels to be used in future studies.
MIV-711 drug will also be studied in postmenopausal women following once daily oral dosing for 14 days, the company said.
The findings from the study are likely to be announced in the first quarter of 2013.
Medivir is a research-based pharmaceutical company focused on the development of high-value treatments for infectious diseases.
In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia to ensure timely commercialisation of its key asset, TMC435, in the Nordic markets, once approved.