Medivir AB (Nasdaq Stockholm: MVIR) today announced positive top-line results from the MIV-711 phase IIa extension study (MIV-711-202). The 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). In addition, the response level of the positive non-significant signals on patient reported pain and other clinical symptoms seen during the initial phase IIa study were maintained with the additional 6 months of treatment in the subgroup continuing in the 202 study. The overall safety and tolerability profile shown in the extension study and the accumulated safety data support the advancement of MIV-711 into further studies as a disease-modifying osteoarthritis drug.
The MIV-701-202 study was conducted in 50 patients with moderate knee osteoarthritis who had previously received 6 months of treatment with either MIV-711 200mg once daily or placebo in the MIV-711-201 study. Patients were eligible to participate in MIV-711-202 based on an assessment of the pain associated with their knee osteoarthritis, assessed on the numeric rating scale (NRS). Patients in MIV-711-201 treated with 200mg once daily were eligible to participate in the extension study if their NRS assessed pain did not worsen after 6 months of treatment. Patients in MIV-711-201 treated with placebo were eligible to participate if their NRS assessed pain worsened after 6 months of treatment. 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.
The outcomes on the secondary endpoint of safety and tolerability after 6 months’ treatment in patients with prior placebo treatment were comparable to the profile seen in the MIV-711-201 study.
In addition to the primary and secondary safety endpoints of the MIV-711-202 study, several other secondary and exploratory endpoints were included in the trial design. These included the effects of 200mg MIV-711 on MRI-assessed joint structure as well as patient reported measures of pain and other clinical symptoms of osteoarthritis.
For patients who received 6 additional months of treatment with MIV-711, the positive signals on patient-reported pain and other clinical symptoms observed in the initial study were sustained. The effect of MIV-711 200mg on clinical symptom outcomes in patients who had previously received placebo in the initial study and received six months of treatment with were consistent with what had previously been seen after 6 months’ treatment with MIV-711 200mg in the initial study.
“We are pleased to have completed the MIV-711-202 study showing that the safety profile of MIV-711 is acceptable and consistent with the profile seen in the MIV-711-201 study,” said John Öhd, Medivir’s Chief Medical Officer. He continued, “Although the data on osteoarthritis symptoms are not placebo controlled in the MIV-711-202 study, we are encouraged that the positive signs on pain and function were maintained throughout the six additional months of treatment. We are confident that the overall profile of MIV-711 from the two phase II studies support its progression into longer-term studies.”
The analysis of the imaging data by which the structural endpoints are assessed is ongoing and will be published when available.