Medivir AB (Nasdaq Stockholm: MVIR) today announced continued progress towards the completion of its phase IIa program for the treatment of osteoarthritis:
- The open label phase IIa extension study has completed enrollment
- The independent Data Monitoring Committee (DMC) has recommended continuation of the extension study based on a review of the accumulated safety data
The extension study of MIV-711 in patients with moderate knee osteoarthritis has now completed enrolment, having achieved its target of recruiting 50 patients. All patients in the extension study were recruited from the initial phase IIa study and receive 200mg MIV-711 once daily.
The headline data from the initial study continues to be expected to be reported in the third quarter of 2017, and the headline data from both groups in the extension study are expected to be reported in the first half of 2018.
The first objective of the extension study is to assess the safety, tolerability and efficacy of six additional months of treatment with MIV-711 in patients treated in the initial study for six months and who showed evidence of response. The initial study and the extension study together provide an opportunity to assess the effect of 12 months of treatment on the structure of the diseased knee.
The other objective of the study is to explore the safety, tolerability and efficacy of six months of treatment with MIV-711 in patients who received placebo in the initial study and whose osteoarthritis worsened. These patients with rapid disease worsening may be in particular need of a disease-modifying treatment and the extension study provides a unique opportunity to study the effect of MIV-711 in this patient population.
As part of the study, 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. This review constitutes the first of two planned DMC reviews during the extension study.
“The DMC’s recommendation to continue as planned is a positive outcome”, says Christine Lind, CEO at Medivir. “The combined data from the MIV-711 phase IIa programme have the potential to show that MIV-711 is capable of modifying the course of osteoarthritis. This would be expected to generate significant interest from the pharmaceutical community as well as osteoarthritis patients and their doctors. We look forward delivering the data from these studies over the coming months and to continuing partnering discussions after completion of these studies.”
MIV-711 is being developed as a DMOAD, which is a drug intended to slow or reverse the progressive degeneration of joints affected by osteoarthritis. There are no DMOADs approved for use currently, and the standard of care for osteoarthritis 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.