Potential Progressive MS Treatment, Ibudilast, Approved for Fast Track Development by FDA

MediciNova, Inc., announced that MN-166 (ibudilast) has been approved for “fast track” development by the U.S. Food and Drug Administration (FDA) as a potential treatment for progressive multiple sclerosis (MS). Progressive MS includes both the primary progressive (PPMS) and secondary progressive (SPMS) forms of the disease.

MediciNova’s MN-166 was licensed from Kyorin Pharmaceuticals for its potential in treating relapsing-remitting MS (RRMS). MN-166 is a first-in-class, orally bioavailable, small-molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that works by suppressing pro-inflammatory cytokines and promoting neurotrophic factors. It reduces activated glia cells, which play a significant role in a number of neurological conditions.

Ibudilast’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical studies, that were the basis for investigating its therapeutic utility in neurodegenerative diseases like progressive MS and amyotrophic lateral sclerosis, and in substance abuse and chronic neuropathic pain.

“We are very pleased that MN-166 has received Fast Track Designation for progressive MS and believe this validates its potential to address unmet medical needs for this serious disease. We look forward to providing further updates from our ongoing clinical trial in progressive MS,” Yuichi Iwaki, MD, PhD, MediciNova’s president and chief executive officer, said in a press release.

In MS, an abnormal immune response turns against the patient’s own central nervous system (CNS), including the brain, spinal cord, and optic nerves. The immune system attacks nerve fibers and myelin, a fatty substance that encircles and protects nerve fibers. Damage to myelin and nerve fibers can interrupt nerve impulses between the brain and spinal cord, leading lead to a variety of symptoms that include spasticity, numbness, walking difficulties, fatigue, depression, and cognitive and emotional changes.

Nearly 85 percent of all MS patients are diagnosed with RRMS, characterized by inflammatory attacks on myelin and a series of new or progressing neurologic symptoms. These patients, over time, transition to SPMS, marked by a progressive worsening of neurological function and disability, but few to no relapses. About 10 percent of MS patients are initially diagnosed with PPMS, characterized by a worsening of neurological function from its onset.

Current MS therapies address the inflammatory response in RRMS, but are of limited or no benefit regarding neurodegeneration or brain tissue repair.

The FDA’s Fast Track designation is awarded to speed the development and review of drugs with the potential to address unmet medical needs in serious or life-threatening diseases.