LA JOLLA, Calif.—Yesterday, MediciNova, Inc. announced that the Phase 2 clinical trial of MN-166 (ibudilast) in methamphetamine dependence, which was recently completed by investigators at UCLA, did not meet the primary endpoint of methamphetamine abstinence confirmed via urine drug screens during the final two weeks of treatment (weeks 11 and 12).
Dr. Keith Heinzerling, MD, principal investigator of this study said, “It is disappointing that the study could not achieve the primary endpoint with this study design and setting.”
This study was a randomized, double-blind, placebo-controlled, outpatient Phase 2 study of ibudilast in treatment-seeking individuals with methamphetamine dependence, stratified by HIV serostatus, at a UCLA research clinic. Eligible participants were randomly assigned to MN-166 100 mg/day or placebo treatment for 12 weeks, with twice-weekly clinic visits for counseling, urine drug tests, and safety/medication adherence monitoring. The study was designed 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.
MN-166 demonstrated a favorable safety and tolerability profile. There was not an increased rate of serious or severe adverse events in the MN-166 group compared to the placebo group. There were no infections, no cancers, no cardiovascular events, and no deaths related to MN-166 treatment. The most common treatment-related adverse events during the study were gastrointestinal adverse events, which occurred with a higher frequency in the MN-166 group.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc. noted, “We will conduct further analyses of the data with UCLA researchers, which will help us to better understand how to optimize study design and setting for any future clinical trials in substance dependence. We will discuss the results with NIH/NIDA who provided the funding for this trial, the opioid dependence trials and the alcohol dependence trial. We plan to meet with FDA after we have data from the ongoing study of MN-166 in methamphetamine use disorder at Oregon Health & Science University.”
MN-166 has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova is developing MN-166 for progressive multiple sclerosis (MS) and other neurological conditions such as ALS and substance abuse/addiction. MN-166 is a first-in-class, orally bioavailable, small molecule phosphodiesterase -4 and -10 inhibitor and a macrophage migration inhibitory factor 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 neurodegenerative diseases (e.g., progressive MS and ALS), 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 progressive MS, ALS, and drug addiction.
MediciNova, Inc. is a biopharmaceutical company founded on acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with high 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 MS, ALS and substance dependence (e.g., opioid dependence, methamphetamine 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.