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An Update on Pipeline Drug MN-166

December 19, 2016

Back in March we previewed Ibudilast (MN-166) for you, and now we have the latest update. MediciNova announced that the external Data and Safety Monitoring Board (DSMB) for the ongoing Phase 2b clinical trial of MN-166 in progressive multiple sclerosis has reviewed the results of the interim efficacy analysis and made the recommendation to the NIH National Institute of Neurological Diseases and Stroke that the trial should continue as planned. This recommendation was accepted. 

Dr. Robert Fox at the Cleveland Clinic, the principal investigator of this ongoing NIH-funded Phase 2b clinical trial, commented, "We are very pleased that this important study will continue as planned and we believe this is an encouraging sign.  The unmet medical need for progressive MS patients is extremely high as there is no treatment approved for long-term use for these patients."

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc. commented, "We are very pleased to have successfully completed the interim analysis which included a futility analysis.  As the progressive MS study will now continue as planned, we look forward to providing further updates as we receive results of final data analysis from the study, which are expected in the second half of 2017.”

This phase 2 Secondary and Primary Progressive Ibudilast NeuroNEXT trial involves 28 enrolling clinical sites across the US and aims to evaluate the efficacy, safety and tolerability of MN-166. The drug was administered twice daily to subjects with PPMS or SPMS. The qualifying subjects were randomly assigned to a group that would receive the drug or the inactive control.

The primary objectives of the study are to evaluate the activity of MN-166 versus placebo at 96 weeks as measured by MRI analysis for whole brain atrophy using brain parenchymal fraction and evaluate the safety and tolerability of MN-166 versus placebo administered orally in subjects with PPMS or SPMS. Secondary measures include disability, imaging analyses of brain and retinal tissue integrity, cortical atrophy, cognitive impairment, quality-of-life and neuropathic pain.