MediciNova Announces Secondary Analysis of Phase 2 Trial of MN-166 (ibudilast) in Alcohol Use Disorder Published in 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
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)
About Alcohol Use Disorder
Alcohol use disorder (AUD) is a prevalent and disabling psychiatric disorder with limited treatment options. AUD is a chronic relapsing brain disease characterized by compulsive alcohol use, loss of control over alcohol intake, and a negative emotional state when not using alcohol. According to the National Institute on Alcohol Abuse and Alcoholism (NIAAA), in 2019, an estimated 14.5 million people ages 12 and older in the U.S. have AUD, less than 8% receive treatment for the disease, and less than 4% of people with AUD were prescribed a medication approved by the FDA to treat their disorder. There is a high, unmet medical need for better and more accessible treatments for AUD.
About MN-166 (ibudilast)
MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and for glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) is being evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).
Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund
Source: MediciNova, Inc.
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