Medivir initiates MIV-711 phase Ib trial in healthy volunteers

Medivir AB (OMX: MVIR), the research-based pharmaceutical company focused on the development of high-value treatments for infectious diseases, is reporting today that a clinical phase Ib trial of the company's candidate drug (CD) MIV-711 has commenced.

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 program 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 program 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 results by the end of this year."