Ibutilast MN-166Ibudilast, labeled MN-166 by MediciNova, is a potential oral treatment for all forms of multiple sclerosis (MS) and for other neurodegenerative disorders, like amyotrophic lateral sclerosis. The drug, currently in clinical testing for these diseases, has long been marketed in Japan and Korea to treat post-stroke complications and bronchial asthma.

MediciNova licensed the drug from Kyorin Pharmaceutical for potential utility in relapse-remitting multiple sclerosis (RRMS), and later obtained rights to investigate it in  progressive MS and other neurological conditions.

How MN-166 Works

The main mode of action of MN-166 is that it is a glial attenuator that suppresses pro-inflammatory cytokines IL-1ß, TNF-a, and IL-6, and possibly upregulates the anti-inflammatory cytokine IL-10. It has additionally been shown to be a toll-like receptor 4 (TLR4) functional antagonist that may contribute to its attenuation of neuroinflammation.

While it is considered an experimental drug in the United States and Europe, MN-166 involves the redirection of ibudilast, which has an established safety profile from its long use in Asia.

MediciNova was awarded a method of use patent in January 2012, which runs until 2029, to treat patients with both primary progressive and secondary progressive MS with MN-166, either alone or in combination.

Next Steps For Ibudilast

MediciNova completed a Phase 2 multicenter, randomized, double-blind, and placebo-controlled clinical trial of MN-166 in 297 patients with relapsing MS in April 2008, demonstrating significant positive outcomes in three measures indicative of a potential disease-progression modifying effect — slower rates of disability due to nerve fiber damage, reduction in brain volume loss, and a reduced relative risk of new inflammatory lesions converting to persistent black holes, which are associated with relapses. The treatment was well-tolerated over the trial’s two years.

In 2013, MediciNova announced the initiation of a similar Phase 2b clinical trial in 250 patients with progressive forms of MS. This trial, NCT01982942, is funded by the U.S. National Institutes of Health (NIH), and expected to conclude in May 2017. This trial aims at determining the safety, tolerability, and activity of MN-166 administered twice daily (100 mg/day) versus placebo over 96 weeks. Its principal investigator is Robert Fox, MD, MS, staff neurologist at the Mellen Center for Multiple Sclerosis at the Cleveland Clinic.

Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

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