Positive Results for MN-166 in Phase 2 AUD Trial
On June 21, 2021, MediciNova, Inc. (NASDAQ:MNOV) announced that positive results from a Phase 2 trial of MN-166 (ibudilast) in alcohol use disorder (AUD) were published in Translational Psychiatry, a Nature publication (Grodin et al., 2021). The trial was a two-week randomized, double blind, placebo placebo-controlled study that tested the effect of ibudilast on mood, heavy drinking, and neural reward signals in individuals with AUD (NCT03489850). The following image gives an overview of the trial, in which a total of 52 individuals were randomized, 50 completed the study, and 45 provided usable neuroimaging data (ibudilast, n=20; placebo, n=25). There were no significant differences between groups on any baseline characteristic and overall medication compliance was high (98.7% via self-report and 97.1% via pill count).
The following table summarizes the statistical models and the effect of different predictor variables on mood, heavy drinking, and craving. While ibudilast did not have an effect on mood, it did significantly reduce the odds of heavy drinking days (HDD) compared to placebo by 45% (P=0.04). This was in spite of the fact that there was no significant difference in adverse evets (AEs) between groups, indicating that the reduction was not due to an increased side effect, such as nausea, in the ibudilast group. In addition to reducing the odds of heavy drinking days, ibudilast reduced alcohol craving compared to placebo on non-drinking days (P=0.02).
For the brain imaging studies, alcohol induced the expected brain activation in all participants. The following figure on the left shows that ibudilast significantly attenuated bilateral ventral striatal (VS) activation to alcohol cues (P=0.01). There was also a significant effect of sex on percent signal change, with men having higher activation than women. The following image on the right shows that in individuals who had decreased activation of the VS to alcohol, ibudilast treatment resulted in a lower number of drinks per drinking day in the week following the scan.
The results showing ibudilast significantly reduced the probability of heavy drinking compared to placebo builds on previous research showing that ibudilast has a positive effect on AUD patients. In addition, the results showing VS activation to alcohol cues was predictive of drinking in the week following the neuroimaging scan suggests a biobehavioral mechanism that ibudilast acts through by reducing the reward response to alcohol cues in the brain and, in turn, resulting in a reduction in heavy drinking. Dr. Lara Ray, who conducted the aforementioned study, is currently conducting another clinical trial of ibudilast for the treatment of AUD that includes a 12-week treatment period with a primary outcome of percent heavy drinking days (NCT03594435) and we look forward to results from that study. The positive results from this study has led us to increase the probability of approval for MN-166 in AUD, which has increased our valuation from $26.50 to $28.
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