Medivir AB Reports Positive Topline Results from Phase IIa Osteoarthritis Study

Medivir AB (MVIR) today announces positive top line data from MIV-711-201, the 6-month initial phase IIa study of MIV-711 in patients with moderate knee osteoarthritis. MIV-711, which is being developed as a disease-modifying osteoarthritis drug (DMOAD), demonstrated benefit on joint structure in the study. Patients who received MIV-711 for 6 months had significantly lower increases in bone area and cartilage thinning in the diseased knee compared to patients who received placebo. With clinical data demonstrating MIV-711's potential to be the first disease modifying drug for osteoarthritis, Medivir has retained strategic advisors to seek a partner for the future development of MIV-711.

Increasing joint bone area and thinning of the joint cartilage in the femur, assessed using magnetic resonance imaging (MRI), are measures of the ongoing degenerative changes in the joint and have been shown to correlate well with overall clinical disease progression in osteoarthritis patients1,2. The same imaging techniques, which are objective measures of disease progression, were used to assess changes in joint structure in the MIV-711-201 study:

• Patients receiving MIV-711 once daily at both 100 and 200 mg doses experienced approximately 65% reductions in femoral joint bone area progression in the 6-month period compared to those receiving placebo (unadjusted p-values for both doses < 0.005). Similar to previous epidemiological cohort studies, patients who received placebo in this study showed a 1% increase in medial femur joint bone area over the 6-month treatment period.

• MIV-711 also showed a benefit on cartilage degradation, with the 100mg group experiencing a 70% reduction in median loss of femoral cartilage thickness relative to placebo group, and the 200mg group even showing a small increase in median cartilage thickness.

MIV-711 did not show a statistically significant effect on patient-reported numerical rating scale (NRS) pain following 6 months of treatment, the primary endpoint of the study. Nevertheless, consistent tendencies favouring both the 100mg and 200mg groups were observed across patient-reported pain and other patient-reported symptoms.

The study data also indicate that both MIV-711 doses showed acceptable safety and tolerability for this patient population.

"The finding that MIV-711 slows the degenerative changes on both bone and cartilage in knees affected by osteoarthritis is an enormously exciting finding" said Professor Philip Conaghan, Professor of Musculoskeletal Medicine at the University of Leeds, UK, and lead investigator on the MIV-711-201 study. "Long-term studies in osteoarthritis patients have shown that the progression of degenerative changes in diseased joints measured by MRI is correlated with subsequent total joint replacement. Although MIV-711 didn't show a statistically significant improvement on pain in this limited-duration study, the effects on joint structure and trends in symptoms observed after 6 months should result in significant clinical benefit if sustained over a longer period of time. With no disease modifying drugs currently available, osteoarthritis patients are in urgent need of medications that can slow or halt the progression of joint damage. The findings from this study, in which we showed structural benefit with an orally administered drug after only 6 months of treatment are unique and show promise for the future of osteoarthritis treatment."

Detailed data from the study will be submitted for presentation at an upcoming scientific meeting.

"This unprecedented data showing the beneficial effects on joint structure degeneration, coupled with its acceptable safety profile strongly support the further development of MIV-711 as a disease-modifying osteoarthritis drug" said Christine Lind, Medivir CEO. "As Medivir remains focused on its portfolio of oncology projects, we will be initiating efforts to find a partner to advance the development of MIV-711 and bring this promising treatment to osteoarthritis patients."

Medivir has initiated a process to seek a partner for future MIV-711 development and has retained Greenhill & Co. as advisors.

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