Benzinga | Jun 21, 2021 06:30AM EDT

MediciNova Announces Positive Results from Phase 2 Trial of MN-166 in Alcohol Use Disorder Published in Nature's Translational Psychiatry Journal

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 positive results from a Phase 2 trial of MN-166 (ibudilast) in alcohol use disorder (AUD) were published in Nature's Translational Psychiatry.

The clinical trial was a collaborative effort between MediciNova and Dr. Lara Ray, Professor, Department of Psychology and Department of Psychiatry and Biobehavioral Sciences, Brain Research Institute at the University of California at Los Angeles (UCLA) and was funded by the Center for Study of Opioid Receptors and Drugs of Abuse (CSORDA; National Institute on Drug Abuse Grant P50-DA005010). This study was a randomized, double-blind, placebo-controlled Phase 2 trial to evaluate the effect of 14 days of ibudilast treatment on mood, heavy drinking, and neural reward signals in individuals with AUD. A total of 52 AUD patients were enrolled in this trial.

The publication, entitled "Ibudilast, a neuroimmune modulator, reduces heavy drinking and alcohol cue-elicited neural activation: a randomized trial" was authored by Dr. Lara Ray and colleagues at UCLA.

Key results reported in the publication include the following:

* Ibudilast did not have a significant effect on negative mood.

* Ibudilast, relative to placebo, reduced the odds of heavy drinking across time by 45% (OR=0.55, (95% CI: 0.30, 0.98)).

* Ibudilast attenuated alcohol cue-elicited activation in the ventral striatum (VS) compared to placebo (p=0.01).

* Alcohol cue-elicited activation in the VS predicted subsequent drinking in the ibudilast group (p=0.02), such that individuals who had attenuated ventral striatal activation and took ibudilast had the fewest number of drinks per drinking day in the week following the scan.

* Ibudilast reduced alcohol craving compared to placebo on non-drinking days (p=0.02).

* These findings extend preclinical and human laboratory studies of the utility of ibudilast to treat AUD and suggest a biobehavioral mechanism through which ibudilast acts, namely, by reducing the rewarding response to alcohol cues in the brain leading to a reduction in heavy drinking.

Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, "We are very pleased that the results from this Phase 2 trial in alcohol use disorder have been published. We are excited that MN-166 reduced the odds of heavy drinking by 45% after only 14 days of treatment. Our first clinical trial demonstrated that ibudilast significantly reduced basal, daily alcohol craving in AUD patients. We are thrilled that MN-166 has demonstrated great potential to reduce the increasing problem of alcohol use disorder."

Professor Lara Ray commented, "During the COVID-19 pandemic, uncertainty, unemployment, and isolation were factors that increased anxiety and stress, and led to new cases of alcohol misuse and AUD. Our findings from this Phase 2 clinical trialibudilast improved drinking outcomes and reduced the rewarding response to alcohol in brains of individuals with AUDare timely and very encouraging for the treatment of AUD."