MIV-711 Osteoarthritis Trial: Successful third independent review of safety data and trial continues without any modifications
Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announces that the independent Data Monitoring Committee (DMC) has had its third 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 review of the accumulated safety data after the first 150 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 extension study 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 GI-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.
Further information on the trial planning and conduct can be found on www.clinicaltrials.gov with identifier NCT02705625.
For further information, please contact:
Richard Bethell, CSO Medivir AB, mobile +46 (0)72-704 3211
Ola Burmark, CFO Medivir AB, mobile: +46 (0) 725 480 580
Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 8.30 CET on 8 December 2016.
Medivir is a research based pharmaceutical company with a research focus on oncology and infectious diseases. 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 need. Our commercial organization provides a portfolio of specialty care pharmaceuticals on the Nordic market. Medivir is listed on the Nasdaq Stockholm Mid Cap List.