お知らせ • Jun 30
MediciNova, Inc. Announces Presentation of Results from the Phase 2B Trial of Mn-166 (Ibudilast) in Alcohol Use Disorder at the 46th Annual Research Society on Alcohol Use Disorder at the 46th Annual Research Society on Alcohol (RSA) Scientific Meeting
MediciNova, Inc. announced that Principal Investigator, Lara Ray, PhD, Professor, Department of Psychology, University of California Los Angeles (UCLA) presented the results of the Phase 2b trial of MN-166 (ibudilast) in alcohol use disorder (AUD) at the 46th Annual Research Society on Alcoholism (RSA) Scientific Meeting held June 24 - 28, 2023, in Bellevue, Washington. 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 UCLA, and was funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a component of the National Institutes of Health (NIH). This study was a randomized, double-blind, placebo-controlled, Phase 2b clinical trial in treatment-seeking men and women with moderate or severe AUD. Participants took MN-166 (ibudilast) 50 mg or placebo twice a day for 12 weeks. A total of 102 subjects were enrolled in this trial. The primary objective of the trial was to evaluate the effects of MN-166 (ibudilast) vs. placebo on percent heavy drinking days defined as =5 drinks for men and =4 drinks for women over the course of a 12-week treatment period. MN-166 (ibudilast) treatment was not superior to placebo for reducing percent heavy drinking days. Also, MN-166 (ibudilast) treatment was not superior to placebo for the secondary endpoints of 1) the number of drinks consumed per day, 2) the number of drinks consumed per drinking day, 3) the percentage of days abstinent, 4) the percentage of subjects with no heavy drinking days, and 5) the percentage of subjects who are abstinent. This study was a randomized, double-blind, placebo-controlled, outpatient clinical trial that targeted treatment-seeking men and women who met current DSM-5 diagnostic criteria for moderate or severe AUD. Participants took MN-166 (ibudilast) 50 mg or placebo twice a day for 12 weeks and completed the NIAAA-developed computer-delivered program “Take Control” during the study. The primary objective of the trial was to test whether MN-166 (ibudilast) will decrease percent heavy drinking days (defined as =5 drinks for men and =4 drinks for women), as compared to placebo, over the course of the 12-week treatment period. The secondary objectives were to evaluate the efficacy of MN-166 (ibudilast) on 1) the number of drinks consumed per day, 2) the number of drinks consumed per drinking day, 3) the percentage of days abstinent, 4) the percentage of subjects with no heavy drinking days, and 5) the percentage of subjects who were abstinent, as well as measures of alcohol craving and negative mood, over the course of the 12-week treatment period. Exploratory endpoints included evaluation of 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 over the course of the 12-week treatment period. 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), an estimated 29.5 million people in the U.S. have AUD and only 5% received treatment for the disease in the past year. There is a high unmet medical need for better treatments for AUD. 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 is also in development for glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy), Long COVID, and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).