MediciNova Announces Secondary Analysis of Phase 2 Trial of MN-166 (ibudilast) in Alcohol Use Disorder Published in Alcoholism: Clinical and Experimental Research

Excerpt from the Press Release:

LA JOLLA, Calif., April 07, 2022 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that a secondary analysis of a Phase 2 clinical trial of MN-166 (ibudilast) in alcohol use disorder (AUD) was published in the journal Alcoholism: Clinical and Experimental Research.

The publication entitled, “The effect of neuroimmune modulation on subjective response to alcohol in the natural environment,” co-authored by MediciNova’s collaborator, Dr. Lara Ray, Professor, Department of Psychology  and  Department of Psychiatry and Biobehavioral Sciences, Brain Research Institute at the University of California, Los Angeles and colleagues, describes a secondary analysis of a two-week clinical trial of MN-166 (ibudilast) that enrolled 52 non-treatment seeking participants with AUD.  

Eligible participants were randomized to MN-166 (ibudilast) or matched placebo and completed daily diary assessments (DDAs) during the two-week period. Each morning, participants retrospectively reported on their mood and craving levels both before and during the previous day’s drinking episode, as well as stimulation and sedation levels during the previous day’s drinking episode. Multilevel models compared the effects of MN-166 (ibudilast) and placebo on subjective alcohol response. Exploratory analyses evaluated whether MN-166 (ibudilast) moderated the relationship between daily stimulation / sedation and alcohol intake and whether withdrawal-related dysphoria moderated the effects of MN-166 (ibudilast) on subjective response.

Key take-aways about MN-166 (ibudilast) in the publication include:

• Initial findings showed that MN-166 (ibudilast), a neuroimmune modulator, reduces rates of heavy drinking and measures of alcohol craving
• MN-166 (ibudilast) did not significantly alter mean levels of stimulation or sedation
• MN-166 (ibudilast) moderated the effect of daily stimulation on same-day number of drinks consumed (p=0.045)
• MN-166 (ibudilast) attenuated alcohol-induced increases in craving compared with placebo (p=0.047) but no other subjective response measures
• MN-166 (ibudilast) may reduce the acute and chronic proinflammatory effects of alcohol, either indirectly through suppression of peripheral inflammation or directly by altering cAMP signaling pathways and suppressing cytokine expression and in the brain (e.g., rewards regions relevant to craving)
• Among individuals without withdrawal-related dysphoria, MN-166 (ibudilast) significantly tempered daily alcohol-induced changes in urge to drink (p=0.021) and positive mood (p=0.001)
• This tempering of alcohol’s effects may reflect MN-166 (ibudilast)’s enhancement of anti-inflammatory and neurotrophic factors suspected to impact dopaminergic signaling in rewards regions, such as the nucleus accumbens, where PDE4 and PDE10 are highly expressed
• Consistent with previous findings, reductions in alcohol craving may represent a primary mechanism of MN-166 (ibudilast)

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