Data monitoring committee gives “Go Ahead” in the MIV-711 osteoarthritis extension study
Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announces that the independent Data Monitoring Committee (DMC) has again recommended continuation of the MIV-711 osteoarthritis extension study without modifications based on a review of the accumulated safety data.
As part of the MIV-711 phase IIa programme, an independent DMC is periodically scheduled to review the accumulated safety data. Based on the present DMC review of all safety data, including unblinded data from the initial study and data to date from the extension study, the DMC has recommended that the extension study should go ahead as planned. This most recent review constitutes the sixth and final planned DMC review during the phase II programme.
”We are encouraged that the overall assessment so far indicates an acceptable safety profile for MIV-711 and look forward to reporting the headline efficacy data from the initial randomized blinded study later this month,” says John Öhd, CMO at Medivir.
MIV-711 is being developed to slow or reverse the progressive degeneration of joints affected by osteoarthritis, and is therefore referred to as a Disease Modifying Osteoarthritis Drug (DMOAD). Since there are no DMOADs approved for use currently, the standard of care for osteoarthritis patients is based on changes in life style and the use of analgesics. The long-term use of analgesics by osteoarthritis patients is associated with an increased risk of side effects such as gastrointestinal bleeding and opioid dependency. DMOADs therefore represent a very large and attractive market opportunity. Medivir estimates that the US market alone is greater than USD 6 billion annually for a drug that impacts disease progression, even if its use was restricted just to patient populations with moderate osteoarthritis in weight-bearing joints.
For further information, please contact:
Anders Lundin, Interim CFO Medivir AB, mobile: +46 (0)731 251 453
John Öhd, CMO Medivir AB, mobile +46 (0) 725 296 200
Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 08.30 CET on 14 September 2017.
Medivir is a research-based pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical needs. Medivir is listed on the Nasdaq Stockholm Mid Cap List.