LA JOLLA, Calif., May 07, 2018 (GLOBE NEWSWIRE) — 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 it plans to initiate a clinical trial of MN-166 (ibudilast) in alcohol dependence and withdrawal in collaboration with researchers at the University of California, Los Angeles (UCLA).
The clinical trial is a collaborative effort between MediciNova, Inc., and Dr. Lara Ray, Professor, Department of Psychology and Department of Psychiatry and Biobehavioral Sciences, Brain Research Institute at the University of California, Los Angeles and is funded by the Center for Study of Opioid Receptors and Drugs of Abuse (CSORDA; National Institute on Drug Abuse Grant P50-DA005010). The proposed clinical trial will evaluate MN-166 (ibudilast) as a potential treatment for individuals diagnosed with alcohol use disorder (AUD), and test whether MN-166 is more effective for those patients who experience withdrawal-related dysphoria than those who do not experience withdrawal. Previous findings showed that MN-166 was effective in blunting alcohol reward among participants with greater depressive symptoms, a hallmark symptom of prolonged alcohol withdrawal.
Lara Ray, PhD, Principal Investigator of the study, commented, “We are pleased to collaborate with MediciNova to continue our evaluation of MN-166 in the treatment of alcohol use disorder. The interplay between affect, withdrawal, and response to MN-166 in this population is an intriguing one.”
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, “We are excited to collaborate with Dr. Ray again to explore further the effects of MN-166 as a pharmacotherapy in AUD. We appreciate the continued grant support for this program by the NIH.”
About the Clinical Trial:
This randomized, double-blind, placebo-controlled, outpatient study plans to enroll 50 non-treatment seeking individuals with moderate-to-severe AUD. Participants will be stratified based on presence or absence of withdrawal-related dysphoria and will be randomly assigned to a 14-day treatment period involving repeat oral administration of either MN-166 escalated up to 100 mg/day or placebo. Ecological Momentary Assessment (EMA), a research method which allows for the examination of dynamic processes associated with depression and depression-related phenomena, will be done on a daily basis. During the treatment period, participants will take the study medication and will report on their alcohol craving as well as mood surveys and standard safety tests. The key study outcomes include whether MN-166 reduces basal level negative affect during abstinence, and in doing so, will interfere with alcohol-induced blunting of negative affectivity as captured during naturalistic drinking episodes. This study will also test whether the clinically beneficial effects of MN-166 are greater in the group with withdrawal-related dysphoria than the non-withdrawal group.
About Alcohol Use Disorder
Alcohol use disorder (AUD) is a prevalent and disabling psychiatric disorder with limited treatment options. According to the National Institute on Alcohol Abuse and Alcoholism (NIAAA), an estimated 16 million people in the U.S. have AUD and less than 10% receive treatment for the disease. There is a high unmet medical need for better treatments for AUD.
About MN-166 (ibudilast)
MN-166 (ibudilast) has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova is developing MN-166 for various neurological conditions such as progressive MS, ALS and substance abuse disorder. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It attenuates activated glia cells, which play a major role in certain neurological conditions. Ibudilast’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical study results and provide the rationale for its therapeutic utility in drug use disorders, neurodegenerative diseases (e.g., ALS and progressive MS), substance abuse/addiction and chronic neuropathic pain. MediciNova has a portfolio of patents which cover the use of MN-166 (ibudilast) to treat various diseases including drug use disorders, ALS, and progressive MS. MN-166 (ibudilast) was granted Fast-Track Designation for the treatment of methamphetamine dependence by the U.S. Food and Drug Administration.
MediciNova, Inc. is a publicly-traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs with a primary commercial focus on the U.S. market. MediciNova’s current strategy is to focus on MN-166 (ibudilast) for neurological disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and substance dependence (e.g., alcohol use disorder, methamphetamine dependence, opioid dependence) and MN-001 (tipelukast) for fibrotic diseases such as nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). MediciNova’s pipeline also includes MN-221 (bedoradrine) for the treatment of acute exacerbations of asthma and MN-029 (denibulin) for solid tumor cancers. MediciNova is engaged in strategic partnering and other potential funding discussions to support further development of its programs. For more information on MediciNova, Inc., please visit www.medicinova.com.
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-221, MN-001, 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-221, MN-001, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova’s operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova’s collaborations with third parties, the availability of funds to complete product development plans and MediciNova’s ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2017 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.