MediciNova, Inc., a publicly-traded biopharmaceutical company developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs, recently announced that the National Institute of Neurological Disorders and Stroke (NINDS) notified the company of full enrollment of their ongoing clinical study evaluating ibudilast (MN-166) for the treatment of progressive multiple sclerosis. The trial randomization is aimed to be completed in about 4 to 6 weeks.
MN-166 (ibudilast) is a first-in-class, orally bio-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.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented in a recent press release, “We are very pleased that this important study is now fully enrolled. We look forward to providing a further update when randomization of all patients has been completed.”
This Phase 2b study called SPRINT-MS (Secondary and Primary Progressive Ibudilast NeuroNEXT trial in Multiple Sclerosis) will be conducted at 28 clinical sites across the United States and will evaluate the efficacy, tolerability and safety of ibudilast (MN-166) administered twice per day in patients suffering with secondary and primary progressive multiple sclerosis (PPMS or SPMS, respectively). In the study a total of 250 patients meeting the study criteria are assigned at random in a 1:1 proportion to either one of two groups: MN-166 (ibudilast) 100 mg per day (50 mg twice per day) or placebo.
Patients with progressive MS who are not currently taking long-term disease modifying therapy (DMT), as well as those who are currently prescribed glatiramer acetate (GA) or interferon beta (IFNβ-1a or IFNβ-1b) treatment were both accepted into the study. Patient randomization will be stratified by therapy status (IFN/GA vs. no DMT) and also by disease status (PPMS vs. SPMS).
The clinical trial primary endpoints include the evaluation of MN-166 activity versus placebo, measured at 96 weeks of treatment with MRI (magnetic resonance imaging) for atrophy in the whole brain with resource to brain parenchymal fraction (BPF). The trial also aims to conduct an evaluation of the tolerability and safety of MN-166 versus placebo given orally to patients with a diagnosis of either PPMS or SPMS.
The clinical trial’s secondary endpoints involve assessing imaging analyses of brain, retinal tissue integrity, disability, neuropathic pain, cognitive impairment, cortical atrophy and patients’ quality-of-life. In the trial, the researchers will also conduct biomarker and pharmacokinetic analyses.
The collaborating entities include NeuroNEXT, the Cleveland Clinic, the National MS Society and MediciNova. NINDS’s Network for Excellence in Neuroscience Clinical Trials, or NeuroNEXT, was created to conduct studies of treatments for neurological diseases through partnerships with academia, private foundations and industry.