Medivir AB has 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.
“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. Medivir 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.