Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today informs that data from the initial phase IIa study of MIV-711, which demonstrated disease-modifying activity in patients with moderate knee osteoarthritis after only six months of treatment, will be presented during the Osteoarthritis Research Society International (OARSI) World Congress, which will take place from 26-29 April 2018 in Liverpool, UK.
The oral presentation will be given by the study’s lead investigator Dr. Philip Conaghan, Professor of Musculoskeletal Medicine at the University of Leeds in the UK, as indicated below:
Friday April 27, 3:10 PM – 3:20 PM (local time).
SIX MONTHS’ TREATMENT WITH MIV-711, A NOVEL CATHEPSIN K INHIBITOR INDUCES OSTEOARTHRITIS STRUCTURE MODIFICATION: RESULTS FROM A RANDOMIZED DOUBLE BLIND PLACEBO-CONTROLLED PHASE IIA TRIAL
Authors: P. G. Conaghan, M. A. Bowes, S. R. Kingsbury, A. Brett, G. Guillard, K. Tunblad, B. Rizoska, T. Larsson, Å. Holmgren, A. Manninen, K. Göhlin, W. Heber, P. Graham, Å. Jansson, C. Wadell, R. Bethell, J. Öhd
Details of all presentations for the 2018 OARSI World Congress are available at the conference website: https://2018.oarsi.org/sites/default/files/docs/2018/oarsi-18-final_draft.pdf
For further information, please contact:
Erik Björk, CFO, Medivir AB, mobile: +46 (0)72 228 2831
John Öhd CMO, Medivir AB, mobile: +46 (0)72 529 62 00
About disease modification in osteoarthritis
Osteoarthritis affects over 30 million adults in the US, and as many as 240 million people worldwide. There are currently no disease-modifying therapies approved for the treatment of the disease. In order to exert a disease modifying effect on osteoarthritis, a prospective Disease Modifying Osteoarthritis Drug (DMOAD) needs to show efficacy on the degenerative changes seen in the joint in terms of bone and cartilage, as well as on clinical benefit. To date, all approved osteoarthritis treatments affect only day to day symptoms and have no effect on the degenerative changes in the diseased joint.
MIV-711 is a potent and selective inhibitor of cathepsin K, the principal protease involved in breaking down collagen in bone and cartilage. It is being developed to slow or reverse the progressive degeneration of joints affected by osteoarthritis, and is therefore a potential 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 to patient populations with moderate osteoarthritis in weight-bearing joints.
About the MIV-711 phase IIa studies
The initial phase IIa study, MIV-711-201, was a randomized, double-blind, placebo-controlled phase IIa clinical trial evaluating the safety and efficacy of 6 months of treatment with MIV-711 compared to placebo for the treatment of patients with moderate knee osteoarthritis. Further information about MIV-711-201 can be found at www.clinicaltrials.gov with the identifier NCT02705625.
The open-label phase IIa extension study, MIV-711-202, is assessing the safety, tolerability and efficacy of six additional months of treatment with MIV-711 in patients treated in the initial study for six months who showed evidence of response, and 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. Headline data from the extension study is expected during the second quarter of 2018. Further information about MIV-711-202 can be found at www.clinicaltrials.gov with the identifier NCT03037489.
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 need. Medivir is listed on the Nasdaq Stockholm Mid Cap List (ticker: MVIR). www.medivir.com.