Medivir announces that the independent Data Monitoring Committee (DMC) held its fourth and final scheduled meeting and recommended continuation of the ongoing randomized, double-blind phase IIa study (MIV-711-201) based on a review of unblinded safety data.
The objective of MIV-711-201 is to evaluate the safety, tolerability and efficacy of six months of treatment with MIV-711 in patients with moderate knee osteoarthritis. As part of the study, an independent DMC is periodically scheduled to review the unblinded safety data from the trial. Based on the last scheduled review of the accumulated safety data, which took place after the first 200 subjects had completed 3 months of treatment, the DMC has recommended that the phase IIa trial of osteoarthritis should continue without any modifications.
It is expected that data from MIV-711-201 will be available in the third quarter of 2017 and that data from the ongoing extension study, MIV-711-202, will be available in the first half of 2018.
MIV-711 is being developed as a DMOAD, i.e. a drug to slow or reverse the progressive degeneration of joints affected by OA. There are no DMOADs approved for use currently, and the standard of care for OA patients is based on analgesics, with the potential for associated side effect risks such as gastrointestinal bleeding and opioid dependency, and changes in life style. DMOADs for osteoarthritis 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.