MediciNova, Inc., has announced the acceptance of an abstract describing their ongoing Phase 2b clinical trial of MN-166 (ibudilast) in progressive multiple sclerosis (MS). The poster is to be presented at the American Academy of Neurology (AAN) 67th Annual Meeting, April 18 – 25, 2015 in Washington, DC. The presentation is titled “NN 102/SPRINT-MS Phase II Trial of Ibudilast in Progressive MS: Baseline Characteristics.”
The National MS Society estimates that MS affects approximately 2.1 million people worldwide. Although there are current treatments, they only slightly improve function in people with MS. Better treatments that halt the progression of the disease are still greatly needed.
MediciNova is a biopharmaceutical company based in La Jolla, California, that focuses on developing treatments for unmet medical needs. According to a press release issued by the company “MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors.”
Pro-inflammatory cytokines are molecules that might contribute to the loss of myelin that occurs in MS, and could act as part of an autoimmune response. Myelin insulates nerve cells and allows them to conduct impulses. When myelin is damaged in MS, this causes problems with movement, pain, and sensory impairments. Neurotrophic factors are protective molecules, that may help central nervous system cells to survive. The medication MN-166 could therefore have multiple effects, stopping inflammation and protecting nerve cells, ultimately helping to improve symptoms in MS.
A MediciNova press release noted, “Current therapies for multiple sclerosis (MS) affect the inflammatory response, but provide limited benefit for neurodegeneration and/or brain tissue repair. There is an unmet need for agents which may provide neuroprotection.”
The poster will include data from the Phase 2 Secondary and Primary Progressive Ibudilast NeuroNEXT trial in Multiple Sclerosis (SPRINT-MS). The study includes 28 clinical sites throughout the United States. This trial will examine the safety, tolerability and efficacy of MN-166 (ibudilast) twice daily in people with primary or secondary progressive multiple sclerosis (PPMS or SPMS).
A total of 250 people will receive control (placebo) or MN-166 (ibudilast) at a total dose of 100 mg/day, twice daily.
The primary goals of the study include examining activity of ibudilast (MN-166) versus placebo at 96 weeks by quantitative magnetic resonance imaging (MRI) analysis to measure degeneration of the brain and to test the safety and tolerability of ibudilast (MN-166) versus placebo. The trial will include additional measurments of disability, imaging analyses of brain and retinal tissue, cognitive impairment, quality-of-life, and neuropathic pain. The researchers also plan analyses to examine how the drug acts in the body (pharmacokinetics) and to measure biological indicators of treatment response (biomarkers).