MediciNova has announced that the ongoing clinical trial of MN-166 (ibudilast) in patients with progressive multiple sclerosis (PMS) has finished the randomisation 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 third quarter of 2016, once half of the patients have completed the treatment over 96 weeks.
Yuichi Iwaki, MD, PhD, president and CEO of MediciNova, said: “We are very pleased to have exceeded the enrolment 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 randomised 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 randomisation 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.
Source: Multiple Sclerosis News Today © BioNews Services 2015 (16/06/15)
MediciNova, Inc. has announced that, as of September 15, 2014, the ongoing Phase 2b trial of MN-166 (ibudilast) in progressive multiple sclerosis (MS) had enrolled 150 of the 250 subjects planned to be enrolled. Enrollment is expected to be completed during the first quarter of 2015.
The study is being funded by the U.S. National Institutes of Health (NIH) and is being conducted by the NeuroNEXT clinical trial network within the National Institute of Neurological Disorders and Stroke (NINDS) at the NIH. The collaboration to perform the study includes 28 academic medical centers, MediciNova and advocacy support from the National Multiple Sclerosis Society. The principal investigator is Robert Fox, M.D., M.S., FAAN, Vice-Chair for Research, Neurological Institute, Cleveland Clinic.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased to have completed 60% of the enrollment in this study. We look forward to providing further updates as the study progresses."
About the Progressive MS Trial
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 will be 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 (IFNβ-1a or IFNβ-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.
About the Cooperative Effort
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. NeuroNEXT sites include many of the leading medical centers in the U.S. The goals of NeuroNEXT include testing of promising neurological therapies in Phase 2 clinical trials, optimizing drug development time and cost components through an established clinical trials infrastructure, and the coordination of public/private sector efforts by leveraging NINDS' existing relationships with academic investigators and patient advocacy groups. A clinical coordinating center for the network is based at Massachusetts General Hospital and the data coordinating center is at University of Iowa. Dr. Fox and colleagues at the Cleveland Clinic collaborate with co-investigators at academic medical centers in the NeuroNEXT network. The National MS Society is providing patient advocate input and trial enrollment awareness. MediciNova holds the trial IND with the FDA Division of Neurology Products and additionally provides scientific and analytical support and drug and placebo supply.
Source: CNN money © 2014 Cable News Network (24/09/14)