Locally based MediciNova Inc. is collaborating with UCLA and the National Institutes on Drug Abuse to test the effectiveness of one of its lead compounds in treating methamphetamine dependency.
The NIDA, which is part of the National Institutes of Health, will be funding a Phase 2 study of MediciNova’s MN-166 that will be conducted at UCLA starting early next year. MediciNova is estimating the total contribution by NIDA at $2.3 million, with undisclosed additional costs associated with supplying the medication and providing regulatory and scientific support covered by MediciNova.
The UCLA methamphetamine Phase 2 study is intended for 140 subjects, of which half will be randomized to placebo and half will be randomized for MN-166, also known as ibudilast. The Phase 2 study builds on an ongoing UCLA MN-166 Phase 1b safety trial in which drug tolerability is being evaluated in a clinical laboratory setting.
Michael Coffee, MediciNova’s chief business officer, said in contrast to a clinical laboratory study that would typically be conducted in a hospital, this Phase 2 outpatient study will be a critical step in determining the potential for MN-166 to be a useful treatment for methamphetamine dependents under real-world conditions.
“We’re really asking the question, for people out in the community who are not in any treatment centers, will their repetitive use of methamphetamine be reduced?” Coffee said. “These are treatment seeking volunteers.”
Study Will Take Two Years
Kirk Johnson, chief scientific officer for MediciNova, said the Phase 2 study is expected to take two years to complete. If the results are positive, then MN-166 would enter late stage development and be on a path to new drug approval. The FDA would be consulted about a larger Phase 3 trial followed by filing for a new drug review and approval, he said.
“This trial attempts to determine whether this drug has safety and efficacy to move forward or whether other indications that are being developed need to be focused on,” Johnson said.
According to the Substance Abuse and Mental Health Services Administration, and its National Survey on Drug Use and Health, 1.2 million Americans aged 12 years and older abused methamphetamine in the year prior to its 2009 survey.
Steven Shoptaw, Ph.D. and professor at the UCLA Departments of Family Medicine and Psychiatry and Biobehavioral Sciences, said methamphetamine addiction is a tremendous societal burden and also contributes to health care costs from premature conditions such as heart attacks and strokes in relatively young patients to increased transmission of infectious diseases, including HIV.
Keith Heinzerling, assistant professor at the UCLA Department of Family Medicine and principal investigator for the Phase 2 trial, said in addition to the complications of addiction to a patient or their family through psychological and interpersonal or legal issues associated with committing crimes, communicable disease has long been tied to drug abuse. This pending study will be one of the largest methamphetamine addiction trials to date that will specifically look at HIV-related outcomes that are important for public health and health care cost savings, he said.
Medication Has Dual Purpose
The MN-166 medication has the dual purpose of treating the addiction and preventing the transmission of HIV infection, he said.
“If people reduce their drug use the idea is hopefully they’ll reduce their risky behavior associated with drug use and one is high-risk unprotected sex that could lead to HIV transmission,” said Heinzerling, adding that there’s sound evidence that methamphetamine addicts have difficulty adhering to HIV medical care and may not seek treatment at appropriate intervals.
Researchers will also be evaluating such things as methamphetamine’s effect on inflammation in the brain, which is being studied in connection with Alzheimer’s disease, multiple sclerosis, schizophrenia and depression. Heinzerling said they don’t know what role inflammation plays in addiction, but they’ll measure how severe the levels of inflammation were pre-treatment as well as look for indicators about reduction of inflammation with people on the medication relative to placebo.
Heinzerling said although MN-166 is not approved in the U.S., the medication has a good safety record in Asia where it’s in clinical use as a treatment for asthma and stroke complications. The medication was well tolerated in phase one and there were no signs of serious or even mildly concerning adverse events, he said.
“From my perspective I just want to see a treatment that works better,” he said, explaining there are no known medications for effectively treating methamphetamine, marijuana and cocaine use as there are for opioid addictions, alcoholism and smoking cessation. “It’s frustrating and heartbreaking when you see people want to change what’s happening. Some people are not motivated to change, but when people are presented with an opportunity for a better life, there’s only so many times they’ll try and fail before they give up. Having some better treatments would make my life easier and a lot more rewarding.”