Medivir osteoarthritis med Phase 2 shows continuing benefit for joint structure

Medivir AB (Nasdaq Stockholm: MVIR) today announces positive top-line joint structure outcomes from the MIV-711 osteoarthritis phase IIa extension study (MIV-711-202). Treatment with MIV-711 over a total 12 months resulted in a continuing treatment effect on joint bone area growth and prevention of cartilage degradation.

The MIV-711 phase IIa extension study included patients with moderate knee osteoarthritis who completed 6 months of treatment in the initial phase IIa clinical trial (MIV-711-201). Patients were eligible to participate in the extension study if the pain associated with their knee osteoarthritis, assessed on the numeric rating scale (NRS), did not worsen after 6 months of treatment with 200mg once daily, or if their NRS pain symptoms worsened after 6 months of treatment with placebo. Of the total 50 patients in the MIV-711-202 study, 46 patients had received MIV-711 in the MIV-711-201 study, and therefore received a total of 12 months treatment with MIV-711, while 4 patients had previously received placebo. Changes in joint structure were determined using the same magnetic resonance imaging methods that were used in MIV-711-201 and were secondary endpoints in the extension study population that had previously received MIV-711.

The top-line joint structure imaging outcomes from the phase IIa extension study are outlined below:

                                  Outcomes in patients who completed a
                                  total

                                  12 months of treatment with 200mg
                                  MIV-711 once daily



    Mean change in bone area
     in the central              1.09% (0.09%/month)

    medial femur

    Mean change in cartilage
     thickness in the            33mm increase

    central medial femur

These outcomes compare favorably with the outcomes from a historical control group: the patients in the initial phase IIa study treated with placebo for six months. These patients experienced a mean increase of joint bone area in the central medial femur of 0.95%, or a monthly rate of increase in joint bone area of 0.16%/month, and a mean decrease in cartilage thickness in the central medial femur of 66mm. Although there were only four patients in extension study who had previously received placebo in the initial study, the effects of treatment with MIV-711 200mg on both joint structure and clinical symptoms in these patients were consistent with the positive effects that had previously been seen after 6 months of treatment with MIV-711 200mg in the initial study.

As previously announced, the extension study met the primary endpoint, demonstrating that MIV-711 200mg had an acceptable safety and tolerability profile with 6 months of additional treatment with 200 mg MIV-711 following the initial phase IIa study (MIV-711-201) 6-month treatment period (12 months in total).

“The beneficial effects of 12 months of treatment with MIV-711 on joint structure are highly encouraging for its development as a disease-modifying osteoarthritis drug”, said Christine Lind, Medivir’s Chief Executive Officer. “Together with the safety profile of MIV-711 to date, and the consistent positive tendencies we have seen on the clinical symptoms of osteoarthritis throughout the phase II program, these new data provide further strong support for the progression of MIV-711 into later stage development and thus these are important data in our continued discussions with potential partners for MIV-711.”

Medivir plans to submit full data from the MIV-711-202 study for presentation at a future scientific meeting.

https://bit.ly/2uVoAbt