Medivir initiates MIV-711 phase I trial in bone disorders

Medivir AB (OMX:MVIR), a research-based pharmaceutical company focused on infectious diseases, announced today that a phase I clinical trial has been initiated with its investigational drug, MIV-711, a cathepsin K inhibitor for the treatment of bone disorders characterized by excessive bone resorption such as osteoporosis, osteoarthritis and bone metastases.

Maris Hartmanis, CEO of Medivir commented, "This first in man study of Medivir's MIV-711 is an important step in our 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. 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."

MIV-711 is a potent and selective reversible inhibitor of cathepsin K, a protease essential for bone destruction. MIV-711 is being developed as a new therapy in disease states where a reduction in cathepsin K activity would be advantageous.

In this first in human study, MIV-711 will be administered as single ascending oral doses to healthy volunteers, followed by repeated once daily doses for 7 days, with the aim to explore the safety, tolerability and pharmacokinetics. In addition effect on biomarkers relevant for bone and cartilage degradation will be followed. MIV-711 will also be studied in postmenopausal women following once daily oral dosing for 14 days.

The design of the study will allow Medivir to explore how MIV-711 affects biomarkers known to be relevant for measuring bone and cartilage turnover. It will also provide the company with valuable information regarding potential therapeutic dose levels to be used in future studies. The results from this study are expected in the first quarter of 2013.