NIH Funds UCLA Phase 2 Study of MediciNova's MN-166 in Treating Drug Addiction

LOS ANGELES and SAN DIEGO, Sept. 4, 2012 (GLOBE NEWSWIRE) -- The University of California, Los Angeles' (UCLA's) Department of Family Medicine/Center for Behavioral and Addiction Medicine, and MediciNova, Inc. a biopharmaceutical company traded on the NASDAQ Global Market (MNOV) and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), today announced approval and funding by the National Institutes on Drug Abuse (NIDA), part of the National Institutes of Health, of a Phase 2 clinical trial studying the use of MN-166 (ibudilast) for the treatment of methamphetamine addiction. Building on an ongoing UCLA MN-166 Phase 1b safety trial, NIDA has now awarded grant funding for a statistically powered Phase 2 outpatient study in methamphetamine addicts. MediciNova will provide drug supply and regulatory support for the Phase 2 trial.

"UCLA has long recognized the danger of methamphetamine abuse, and NIDA has actively supported our research on understanding methamphetamine's effects on the brain and behavior in order to develop prevention and treatment strategies, including medications," said Steven Shoptaw, Ph.D., Professor, UCLA Departments of Family Medicine and Psychiatry and Biobehavioral Sciences. "Methamphetamine addiction is a tremendous societal burden and also contributes to healthcare costs from premature conditions such as heart attacks and strokes in relatively young patients to the increased transmission of infectious diseases, including HIV. We are pleased to partner with NIDA and MediciNova to help move forward this important study of MN-166 to test its potential utility in this devastating condition."

According to the Substance Abuse and Mental Health Services Administration (SAMHSA) and their National Survey on Drug Use and Health, 1.2 million Americans aged 12 years and older abused methamphetamine in the year prior to their 2009 survey. An independent study conducted by the Rand Corporation estimated the overall cost impact of methamphetamine use in the U.S. "reached more than an estimated $23.4 billion in 2005."

"Preclinical studies have shown that MN-166 may prevent the activation of certain cells in the central nervous system, called glial cells, that have been linked to drug dependence. We are very excited to move this promising molecule into a Phase 2 clinical trial in partnership with MediciNova and NIDA," said UCLA's Keith Heinzerling, M.D., Assistant Professor, UCLA Department of Family Medicine, Medical Director, UCLA Center for Behavioral and Addiction Medicine, and principle investigator of the trial. "This study has real public health relevance because a medication treatment may improve health outcomes and reduce the public health burden of methamphetamine dependency, especially those with HIV infection, where there is high risk of co-morbidity."

"We are excited to collaborate with the expertise of NIDA and UCLA in studying the potential of MN-166 for methamphetamine addiction," said Dr. Yuichi Iwaki, President and CEO of MediciNova. "Along with our lead clinical program, MN-221 for acute exacerbation of asthma, the broad potential of MN-166 for drug addiction, progressive multiple sclerosis, and neuropathic pain represents a core focus of our development efforts."

About the Trial

The Phase 2 trial will study the safety and efficacy of MN-166 (ibudilast) for the treatment of methamphetamine dependence in treatment-seeking volunteers (N = 140) who will be randomly assigned 1:1 to MN-166 at a dose of 100 mg/day or matching placebo. Half of the trial participants in each treatment group will have a co-diagnosis of HIV as methamphetamine addiction in HIV-positive individuals is a growing issue. During the 12-week outpatient study, dependent subjects will participate in thrice-weekly clinic visits for health checkups, counseling, urine drug screens, and medication adherence monitoring. The study is powered to detect a statistically significant benefit of MN-166 over placebo on the primary study outcome of methamphetamine abstinence during the final two weeks of treatment -- an outcome favored by regulatory authorities for addiction medication assessment. Additional endpoints include the effect of ibudilast on methamphetamine use and neurocognitive performance as well as regulation of HIV-associated factors such as T-cell counts and sexual behavior.

For more information on the MN-166 Phase 2 clinical trial, please visit http://clinicaltrials.gov.

About Methamphetamine and Addiction

Source NIDA

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NIH Funds UCLA Phase 2 Study of MediciNova's MN-166 in Treating Drug Addiction