LA JOLLA, Calif., Jan. 30, 2023 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company trading on the NASDAQ Global Market (NASDAQ:MNOV) and the Tokyo Stock Exchange’s JASDAQ Market (Code Number: 4875) ) today announced the completion of enrollment for its Phase 2b clinical trial evaluating MN-166 (ibudilast) for the treatment of alcohol use disorder (AUD).
This clinical trial was funded by the National Institute of Alcohol Abuse and Alcoholism (NIAAA). NIAAA R01 research funding (R01AA026190) was awarded to Dr. Lara Ray, PhD, ABPP, Principal Investigator, Department of Psychology, and Brain Institute for Psychiatry and Behavioral Sciences, University of California, Los Angeles (UCLA). This clinical trial evaluated MN-166 (ibudilast) as a potential treatment to reduce alcohol consumption in treatment-seeking patients diagnosed with AUD. MediciNova provided drug supply and regulatory support for clinical trials.
Lead investigator of the study, Dr. Lara Ray, commented: A recent study of MN-166 (ibudilast) has shown it to be a safe and promising compound for the treatment of AUD, and we would like to begin our analysis. ”
Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer, MediciNova, Inc. Participants who contributed to the successful registration. I am happy that you have completed your registration. We look forward to reporting the topline results. ”
About clinical trials
This study was a randomized, double-blind, placebo-controlled, outpatient clinical trial that enrolled 102 treatment-seeking men and women with moderate or severe AUD. The participant took her MN-166 (ibudilast) 50 mg or placebo twice daily for 12 weeks and completed a web-based program developed by NIAAA. Control During study. The primary endpoint of the trial was whether MN-166 (ibudilast) reduced the number of heavy drinking days (defined as ≥5 drinks in men and ≥4 drinks in women) compared to placebo over his 12-day period. is to test weekly trial. A secondary endpoint is to test the efficacy of MN-166 (ibudilast). 5) Proportion of subjects without heavy drinking and measures of alcohol cravings and negative moods over the course of the 12-week trial. Exploratory endpoints included whether her MN-166 (ibudilast) effects on the primary and secondary endpoints were moderated by depressive symptoms, and whether MN-166 (ibudilast) include assessing whether it reduces neuroinflammation in
About Alcohol Use Disorder
Alcohol use disorder (AUD) is a common and disabling mental disorder with limited treatment options. According to the National Institute of Alcohol Abuse and Alcoholism (NIAAA), an estimated 14.5 million people in the United States have her AUD, and less than 10% of them receive treatment for the disease. There is a high unmet medical need for better treatments for AUD.
About MN-166 (ibudilast)
MN-166 (ibudilast) is a small molecule 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). Also in development for glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorders. Additionally, MN-166 (ibudilast) was evaluated in patients at risk of developing acute respiratory distress syndrome (ARDS).
MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad end-stage pipeline of novel small molecule therapies for inflammatory, fibrotic and neurodegenerative diseases. Based on his two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), which have multiple mechanisms of action and strong safety profiles, MediciNova has 11 clinical development programs. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM), and for progressive multiple sclerosis (MS ) is ready for Phase 3. MN-166 (ibudilast) is also being evaluated in Phase 2 trials in glioblastoma and substance addiction. MN-001 (tipelukast) is being evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-initiated clinical trials funded through government grants.
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 future developments and effects of MN-166, MN-001, MN-221 and MN-029. These forward-looking statements “believe,” “expect,” “anticipate,” “intend,” “estimate,” “predict,” “could,” “could,” may precede, follow, or otherwise include the word “may”. “may”, “will”, “would”, “considering”, “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties and could cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. There is a nature. Factors that could cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include MN-166, MN-001 and future partners for the development of MN. or the risk of obtaining a subsidy. -221, MN-029, and a clinical trial designed to meet the risks, potential costs, anticipated timing, and FDA of raising sufficient capital, if necessary, to contribute to MediciNova’s operations and clinical development. risks and uncertainties inherent in clinical trials, including risks associated with further development guidance and feasibility considering these factors; product development and commercialization risks; risks of delay or failure to obtain or maintain regulatory approval; risks associated with relying on third parties to sponsor and fund clinical trials; Risk Product Candidate Intellectual Property Rights, and the ability to defend and enforce such Intellectual Property Rights, on which MediciNova is relied upon to conduct its clinical trials and manufacture Product Candidates to perform as expected; Risk of failure of third parties involved, risk of increased costs Delays due to delays in initiation, enrollment, completion or analysis of clinical trials, or significant issues with adequacy of clinical trial design or conduct of clinical trials, and to regulatory authorities the expected timing of the application, MediciNova’s collaboration with third parties, the availability of funding to complete the product development plan, and the availability of third party funding for the program and, if necessary, sufficient MediciNova’s ability to raise sufficient capital and other risks and uncertainties described in MediciNova’s filings with the Securities and Exchange Commission, including its Annual Reports on Form. 10-K 1 for the year ended December 31, 202, and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intention or obligation to revise or update these forward-looking statements.