MediciNova’s MN-166 shows positive risk reduction in progressive MS
MediciNova (MNOV) announced the presentation of additional positive clinical data from the SPRINT-MS Phase 2b Trial of MN-166 – ibudilast – in progressive multiple sclerosis, conducted through the National Institutes of Health-sponsored NeuroNEXT network.
MN-166 demonstrated a 26% reduction in the risk of confirmed disability progression compared to placebo.
Confirmed disability progression was a secondary endpoint in this Phase 2b trial but would be considered a primary endpoint in Phase 3.
MediciNova’s power analysis has determined that a Phase 3 trial of MN-166 that enrolls approximately 700 subjects will be sufficiently powered to achieve statistical significance for confirmed disability progression.
As reported in October 2017, the SPRINT-MS Phase 2b Trial of MN-166 in progressive MS achieved both primary endpoints. MN-166 (ibudilast) demonstrated a statistically significant 48% reduction in the rate of progression of whole brain atrophy compared to placebo, and demonstrated a favorable safety and tolerability profile.
The most common treatment-emergent adverse events during the study were gastrointestinal adverse events, which occurred with a higher frequency in the MN-166 group, and upper respiratory tract infections, which occurred with a higher frequency in the placebo group.
The MN-166 (ibudilast) portfolio, which includes the Phase 2-staged lead drug compound and proprietary analogs, represents novel, first-in-class, non-opioid drugs for the treatment of drug addiction, progressive multiple sclerosis and pain.
MN-166 is a first-in-class, orally bioavailable, small molecule glial attenuator that suppresses pro-inflammatory cytokines IL-1ß, TNF-a, and IL-6, and may upregulate the anti-inflammatory cytokine IL-10.
MNOV closed at $8.32.
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