MediciNova is set to receive funding from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) for a Phase llb clinical trial to examine MN-166 (ibudilast) as a potential treatment to decrease alcohol consumption in patients with alcohol use disorder (AUD).
NIAAA is a unit of the US National Institutes of Health (NIH). The funding has been awarded to the trial’s principal investigator Dr Lara Ray.
Ray said: “If MN-166 (ibudilast) is able to reduce drinking compared to placebo in this new study, it will set the stage for a pivotal multi-site clinical trial leading to potential FDA approval of a novel AUD treatment.”
The Phase llb trial is a randomised, double-blind, placebo-controlled, outpatient study which will enrol up to 132 treatment-seeking men and women with moderate or severe AUD.
As part of the trial, the patients will receive 50mg of MN-166 (ibudilast) or placebo twice a day for 12 weeks.
The patients will also complete NIAAA’s web-based programme Take Control during the trial.
The trial’s primary endpoint is to check whether MN-166 (ibudilast) will decrease the percentage of heavy drinking days, defined as more than five drinks for men and more than four drinks for women, compared to placebo throughout the 12-week long trial.
Its secondary endpoints are to check the efficacy of MN-166 (ibudilast) against various parameters, including the number of drinks consumed per day, the percentage of days abstinent, as well as measures of alcohol craving and negative mood, among others.
The trial’s exploratory endpoints comprise whether the effects of MN-166 (ibudilast) on the primary and secondary endpoints are moderated by depressive symptomatology and whether MN-166 (ibudilast) reduces neuroinflammation during the trial.