MediciNova receives FDA approval to proceed with initial trial of ibudilast

Sep 27 2010

MediciNova Inc, a biopharmaceutical company publicly traded on the NASDAQ Global Market (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number:4875), today reported FDA's approval to proceed with an initial trial of the company's neurological drug candidate, ibudilast (MN-166/AV411), as a potential new pharmacotherapy for methamphetamine addiction. The study is largely funded by the National Institute on Drug Abuse (NIDA). The study will be led by Steven Shoptaw Ph.D., Principal Investigator and Professor of Family Medicine and Psychiatry and Biobehavioral Sciences, and colleagues at UCLA who are established clinical research investigators in the treatment of drug addiction. 

"We are excited to participate in a study of this nature, for this unmet medical need, in partnership with NIDA and UCLA," said Yuichi Iwaki, M.D. Ph.D., MediciNova's Chief Executive Officer. "The initiation of this trial represents a model of translational medicine and institutional collaboration," added Kirk Johnson, Ph.D, MediciNova's Chief Scientific Officer. Consideration by NIDA of ibudilast for certain drug addiction syndromes began a few years ago founded upon its unique glial cell-attenuating mode of action, supportive pre-clinical data, and ibudilast's clinical profile. Ibudilast has been used in asthma and post-stroke disorders in Japan for nearly 20 yrs and has also been utilized at higher doses with encouraging outcomes in company-sponsored clinical trials in multiple sclerosis and neuropathic pain. Collaborative planning between the organizations led to NIDA support of both pre-clinical and clinical investigations: a clinical trial for opioid withdrawal with addiction experts at Columbia University-New York State Psychiatric Institute that is nearly completed and pre-clinical studies testing ibudilast's use in methamphetamine addiction with Dr. Patrick Beardsley at the Medicial College of Virginia. The animal pharmacology studies, wherein ibudilast demonstrated efficacy in reducing methamphetamine relapse, were published in June in the European Journal of Pharmacology. 

The UCLA Phase Ib clinical study will involve 12 methamphetamine-dependent volunteers admitted into a hospital unit for approximately two-week phases wherein they receive low or high dosage-strength oral capsules (AV411), or placebo control, and are not allowed methamphetamine except for controlled periods wherein saline or methamphetamine are infused in a blinded fashion. Each subject will cross-over onto each oral treatment option (placebo or low- or high-dose). Primary study outcomes are safety and tolerability with secondary endpoints including the monitoring of drug levels in the blood and assessment of craving or other psychological symptoms. 

Methamphetamine abuse is a significant public health concern. Dr. Shoptaw notes that "there is an urgent need for discovery of new medications for this terrible medical disorder in order to reduce suffering and improve the health of our communities." Worldwide prevalence of use of amphetamine-type stimulants, including methamphetamine (MA), is estimated to be greater than that for opioid use and cocaine use combined (UNODC, 2010). While overall methamphetamine use in the U.S. has dropped in the last couple years, it remains a significant issue particularly in the Western states. In Los Angeles, methamphetamine remains a leading primary drug of abuse mentioned at entry to publicly funded treatment centers accounting for nearly 20% of admissions in 2009 (LA County Participant Reporting System).