MediciNova, Inc., a biopharmaceutical company focused on acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs, recently announced that the ongoing clinical trial of MN-166 (ibudilast) in patients with progressive multiple sclerosis (progressive MS) has finished the randomization of 255 patients, exceeding the initial goal of 250 patients.
The National Institute of Neurological Disorders and Stroke (NINDS) aims to conduct an interim analysis of the drug efficacy in the fall of 2016, once half of the patients have completed the treatment over 96 weeks.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented in a recent press release, “We are very pleased to have exceeded the enrollment target in this important study. The unmet medical need for progressive MS patients is extremely high as there is no treatment approved for long-term use for these patients. We look forward to providing further updates as the study progresses.”
MN-166 is a first-in-class, orally bioavailable, small molecule glial attenuator that suppresses pro-inflammatory cytokines IL-1ß, TNF-a, and IL-6, and may upregulate the anti-inflammatory cytokine IL-10/
The SPRINT-MS is a Phase 2 Secondary and Primary Progressive Ibudilast NeuroNEXT trial in patients with Multiple Sclerosis designed to evaluate the tolerability, safety, and efficacy of MN-166 (ibudilast) given twice per day to patients with primary or secondary progressive multiple sclerosis (PPMS or SPMS). It involves 28 clinical sites across the United States.
Patients were randomized to receive an inactive control (placebo) or MN-166 (ibudilast) 100 mg/day (50 mg twice daily). For the remainder of the study, patients may be either untreated with long-term disease modifying therapy (DMT) or may continue either glatiramer acetate (GA) or interferon beta (IFNβ-1a or IFNβ-1b) treatment.
The trial involves a controlled randomization therapy status (IFN/GA verus. no DMT) and disease status (PPMS versus SPMS).
The study primary endpoints are to evaluate the activity of the drug in comparison to the placebo over a period of time of 96 weeks. This will be assessed with magnetic resonance imaging (MRI) using brain parenchymal fraction (BPF). The other primary endpoint involves the assessment of the drug safety and tolerability versus the placebo in with PPMS or SPMS patients. The study secondary endpoints involve imaging analyses of brain and retinal tissue integrity, cortical atrophy disability, cognitive impairment, neuropathic pain and quality-of-life. The study will also include an exploratory analysis of pharmacokinetic and biomarker.