Date: 2015-07-13
Type of information: Interim results
phase: 2
Announcement: interim results
Company: Medicinova (USA - CA)
Product: MN-166 (ibudilast)
Action
mechanism: phosphodiesterase 4 inhibitor/phosphodiesterase 10 inhibitor/protein inhibitor. 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. 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 multiple sclerosis and amyotrophic lateral sclerosis (ALS)), substance abuse/addiction and chronic neuropathic pain. MN-166 has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova licensed MN-166 (ibudilast) from Kyorin Pharmaceutical Co., Ltd. for potential utility in relapse-remitting multiple sclerosis (RRMS). Intellectual property was additionally established or obtained by MediciNova in progressive MS and other neurological conditions.
Disease: multiple sclerosis
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Country: USA
Trial
details: The Phase 2 Secondary and Primary Progressive Ibudilast NeuroNEXT trial in Multiple Sclerosis (SPRINT-MS) involves 28 enrolling clinical sites across the U.S. and is designed to evaluate the safety, tolerability and efficacy of MN-166 (ibudilast) administered twice daily to subjects with primary or secondary progressive multiple sclerosis (PPMS or SPMS, respectively). 250 qualifying subjects are randomly assigned 1:1 to inactive control (placebo) or MN-166 (ibudilast) administered at a dose of 100 mg/day (i.e., 50 mg twice daily). The progressive MS subjects may be either untreated with long-term disease modifying therapy (DMT) or may continue either glatiramer acetate (GA) or interferon beta (IFN?-1a or IFN?-1b) treatment. Hence, randomization will be controlled (stratified) by two factors: therapy status (IFN/GA vs. no DMT) and disease status (PPMS vs. SPMS). The primary objectives of the study are 1) to evaluate the activity of ibudilast (MN-166) versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF), and 2) to evaluate the safety and tolerability of ibudilast (MN-166) (100 mg/day) versus placebo administered orally in subjects with primary or secondary progressive multiple sclerosis. Secondary measures include disability, imaging analyses of brain and retinal tissue integrity, cortical atrophy, cognitive impairment, quality-of-life, and neuropathic pain. Exploratory objectives include pharmacokinetic and biomarker analyses. (NCT01982942)
Latest
news: * On July 13, 2016, MediciNova announced that 50% of patients (127 out of 255 enrolled patients) have completed the 96-week treatment period in the ongoing Phase 2b clinical trial of MN-166 (ibudilast) in progressive multiple sclerosis. The trial’s external Data Safety Monitoring Board will review the results of an interim efficacy analysis in the fourth quarter of 2016. The purpose of the analysis will be to make recommendations to the National Institute of Neurological Diseases and Stroke (NINDS) regarding the trial. * On June 12, 2015, MediciNova announced that the ongoing clinical trial of MN-166 (ibudilast) in progressive multiple sclerosis has completed randomization of 255 subjects, which exceeds the goal of 250 subjects that were planned for participation. NINDS (National Institute of Neurological Disorders and Stroke) is planning to conduct an interim efficacy analysis after half the subjects complete the 96-week treatment period, which analysis is expected to occur in the fall of 2016. * On May 7, 2015, MediciNova announced that it has been notified by NINDS (National Institute of Neurological Disorders and Stroke) that the ongoing clinical trial of MN-166 (ibudilast) in progressive multiple sclerosis (progressive MS) is now fully enrolled. Enrollment activities at all 28 sites are now closed and no new patients will be accepted into the study. Randomization is expected to be completed in approximately 4 - 6 weeks. * On April 23, 2015, MediciNova announced that Dr. Robert J. Fox from the Cleveland Clinic, principal investigator of MediciNova's ongoing Phase 2b clinical trial of MN-166 (ibudilast) in progressive multiple sclerosis, made a presentation today at the American Academy of Neurology (AAN) 67th Annual Meeting in Washington. The presentation included baseline characteristics for the first 228 subjects that were enrolled and randomized in the study as of April 6, 2015. A total of 250 subjects are planned for participation.
