Medivir AB has announced the commencement of phase Ib clinical trial of candidate drug (CD) MIV-711. MIV-711 is a cathepsin K inhibitor intended to treat skeletal disorders that feature high bone resorption such as osteoporosis, rheumatoid arthritis and bone metastases. Cathepsin K is an enzyme that is important to the metabolism of bone and cartilage, and accordingly, inhibition of cathepsin K is expected to have a positive effect on these diseases.

MIV-711’s clinical phase I programme was initiated in May. Phase Ia was recently completed, in which increasing single doses were administered to healthy volunteers to evaluate safety, tolerability, pharmacokinetics and efficacy on biomarkers. The results were very promising and a phase Ib trial has now commenced in which repeated single daily doses will be administered to groups of healthy volunteers including post-menopausal women. Safety, tolerability, pharmacokinetics and efficacy on biomarkers will be evaluated during 7-14 days’ treatment.

Charlotte Edenius, Medivir’s EVP of Research and Development commented, “The first part of the phase I programme offered us important information to enable us to take the next step in the clinical development of MIV-711. The results also support our previous assessment that it will be possible to administer MIV-711 in a low single daily dose. We expect to be able to compile the complete phase I trial’s results by the end of this year.”

Medivir is an emerging research-based pharmaceutical company focused on the development of high-value treatments for infectious diseases.