Text Size: a  |   a 

MS Pipeline Drug: Ibudilast (MN-166)

March 22, 2016

Ibudilast is a formulation labelled as MN-166 by MediciNova. The FDA announced today that this drug has received Fast Track designation for the treatment of patients with progressive multiple sclerosis (primary and secondary).

Ibudilast was accepted for commercialization and public use in Japan almost two decades ago. Recently, MediciNova assumed marketing responsibilities for the therapy after its post-marketing safety profiles were obtained after the Japanese release of the drug. In the United States of America and European countries, it is considered a New Molecular Entity owing to the clinical trials currently underway, and is waiting for approval by the FDA to be accepted as a commercially marketable drug.

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 up-regulates 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.

In 2013, MediciNova had announced a phase IIb of the same clinical trial, recruiting more patients with progressive MS and funded by the US National Institutes of Health (NIH), titled “Secondary and Primary Progressive Ibudilast NeuroNEXT trial in Multiple Sclerosis (SPRINT-MS).” This grant is a cooperative effort between MediciNova and the NeuroNEXT clinical trial network within the National Institute of Neurological Disorders and Stroke (NINDS) at the NIH. This trial aims at determining the safety, tolerability and efficacy of MN-166 (ibudilast) administered twice daily to subjects with PPMS or SPMS. The lead for this trial is Robert Fox, M.D., M.S., FAAN, Staff Neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic.

The trial is no longer enrolling and has an estimated study completion date of May 2017.