MediciNova reports encouraging results from Phase II multiple sclerosis trial
MediciNova has announced positive clinical findings from the completed two-year Phase II clinical trial of orally administered MN-166 for the treatment of multiple sclerosis.
The data showed that sustained disability progression was significantly less likely (by approximately 50%) in those patients receiving MN-166 at either 30 or 60mg per day for 24 months than in those patients receiving the drug for 12 months (p=0.026).
The clinical trial demonstrated that the significant reduction in brain volume loss (p=0.035), as measured by cranial magnetic resonance imaging (MRI) scans, observed after 12 months in patients treated with 60mg per day of MN-166 compared to placebo were again demonstrated in year two of the study. Brain volume loss was significantly less (p=0.030) in patients receiving 60mg per day of MN-166 for 24 months compared to the other treatment groups.
The data also showed that MN-166 treatment at 60mg per day significantly reduced the relative risk for conversion of new inflammatory lesions identified at month two to Persistent Black Holes (PBH), an MRI indicator of neuronal loss, eight months later at month ten by 37% (p=0.011); such lesions that remain unchanged for eight months are considered PBHs as compared to transient inflammatory lesions that are more closely associated with relapses. MN-166 treatment at 30mg per day resulted in a trend toward reducing evolution to PBH (p=0.074). Loss of brain volume and development of PBHs on MRI have been shown to correlate with clinical progression and disability in MS patients.