Medivir initiates phase IIa study of MIV-711 in knee osteoarthritis

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announces the
enrolment of the first patient into a randomized double-blind phase IIa clinical
study of the in-house developed cathepsin K inhibitor MIV-711 in patients with
moderate knee osteoarthritis (OA).
The phase IIa study will enrol 240 patients into 3 arms, each with approximately
80 patients, and compare MIV-711 dosed at 100mg or 200 mg once daily against
placebo. The key objectives are to assess the effect of six months of treatment
with MIV-711 on knee joint clinical pain and on knee OA, assessed using magnetic
resonance imaging, as well as the safety and tolerability of MIV-711. Timing of
data from the study is on plan and expected to be available in the third quarter
of 2017. Further information on the trial planning and conduct can be found on
www.clinicaltrialsregister.eu.
“Despite very large numbers of patients with osteoarthritis – 250m with knee
osteoarthritis alone - there are currently no disease-modifying osteoarthritis
drugs (DMOADs) available for use. Patients with this disease are therefore in
urgent need of improved therapies to manage this debilitating condition.” says
Dr Richard Bethell, EVP R&D at Medivir. “Data from preclinical models have shown
that MIV-711 holds potential as a DMOAD and this has been further supported by
the effects of MIV-711 on biomarkers of bone resorption and cartilage
degradation that were seen in the phase I studies. The initiation of this large,
well-designed phase IIa study offers patients with OA the prospect of improved
treatment, and demonstrates Medivir´s capabilities to advance innovative new
therapies through the clinical phases of development”.
Approximately SEK 140 m of Medivir´s cash is allocated for this phase IIa
program through 2017, of which approximately SEK 25 m was spent during 2015.
DMOADs for osteoarthritis represent a very large and attractive market
opportunity. We estimate 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.
For further information, please contact:
Ola Burmark, CFO Medivir AB, mobile: +46 (0) 725 480 580
Richard Bethell, EVP Research & Development Medivir AB, mobile: +46 (0) 727 043
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Medivir is required under the Securities Markets Act to make the information in
this press release public.
The information was submitted for publication at 10.30 CET on 28 January 2016.
About Medivir
Medivir is a research based pharmaceutical company with a research focus on
infectious diseases and 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. Our
commercial organization provides a growing portfolio of specialty care
pharmaceuticals on the Nordic market. Medivir is listed on the Nasdaq Stockholm
Mid Cap List.