Press release

New data from the MIV-711 phase II program will be presented at the ACR Annual Meeting on October 21

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today informs that new data from the initial phase II 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 American College of Rheumatology (ACR) annual meeting, which will take place from 19-24 October 2018 in Chicago, USA.  

The 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, and will be made on Sunday October 21st:

Abstract 429: The Potential Clinical Relevance of Imaging Biomarker Data from Short-Term Interventional Trials in Osteoarthritis: A Comparison of the Cathepsin K Inhibitor MIV-711 Phase 2a MRI Knee Joint Data and KL-Matched 5577 Knee Control Data from the Osteoarthritis Initiative
Authors: P. G. Conaghan, M. A. Bowes, S. R. Kingsbury, A. Brett, G. Guillard, Å. Jansson, C. Wadell, R. Bethell and J. Öhd

Details of all presentations for the 2018 ACR annual meeting are available at the conference website:
https://www.rheumatology.org/Annual-Meeting

For further information, please contact:
Uli Hacksell, CEO, Medivir AB, mobile: +46 (0)73 125 0615
Erik Björk, CFO, Medivir AB, mobile: +46 (0)72 228 2831

About disease modification in osteoarthritis
Osteoarthritis affects over 30 million adults in the US 1), and as many as 240 million people worldwide. There are currently no disease-modifying therapies approved for the treatment of the disease. The ultimate goal for a treatment that inhibits structural damage or targets the underlying pathophysiology associated with osteoarthritis is to bring clinical benefit, such as reduction of pain. It is however possible that structural endpoints could be accepted as valid outcome measures for accelerated approval in the US. To date, all approved osteoarthritis treatments affect only day to day symptoms and have no effect on the degenerative changes in the diseased joint 2).

About MIV-711
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. Work to find a commercial partner for future development is ongoing.

1) https://www.cdc.gov/arthritis/basics/osteoarthritis.htm
2) https://www.oarsi.org/sites/default/files/docs/2016/oarsi_white_paper_oa_serious_disease_121416_1.pdf

About Medivir
Medivir is a pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitors and nucleotide/nucleoside science and we are dedicated to innovative pharmaceuticals that meet great unmet medical needs. Medivir's clinical pipeline consists of remetinostat for cutaneous T-cell lymphoma, currently in phase II, birinapant in combination with Keytruda® for solid tumors, currently in phase I, MIV-818, a nucleotide prodrug drug for liver cancer that recently entered into a phase I clinical trial, and MIV-711, a potentially disease-modifying osteoarthritis candidate drug with fresh and promising data from the recent phase IIa extension study. Medivir is listed on the Nasdaq Stockholm Mid Cap List (ticker: MVIR). www.medivir.com.