MEDICINOVA INC

We are a biopharmaceutical company focused on developing new treatments for serious diseases where current medical options are insufficient, with a commercial focus on the United States (U.S.) market. Our current strategy involves developing MN-166 (ibudilast) for neurological and other disorders, including progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), chemotherapy-induced peripheral neuropathy, degenerative cervical myelopathy, glioblastoma, and the prevention of acute respiratory distress syndrome (ARDS). We are also developing MN-001 (tipelukast) for fibrotic and other metabolic disorders such as nonalcoholic fatty liver disease (NAFLD) and hypertriglyceridemia. For progressive multiple sclerosis, we completed a Phase 2b clinical trial of MN-166 (ibudilast) for relapsing MS, which showed positive safety and neuroprotective efficacy indicators, suggesting potential for progressive MS. We collaborated with investigators on a Phase 2b clinical trial of MN-166 (ibudilast) in primary progressive and secondary progressive MS, conducted by NeuroNEXT and funded by the National Institute of Health's (NIH) National Institute of Neurological Diseases and Stroke (NINDS). This trial, known as SPRINT-MS, completed randomization of 255 subjects in 2015, exceeding the planned goal of 250 subjects. In October 2017, we announced positive top-line results from SPRINT-MS, which achieved its primary endpoints of whole brain atrophy and safety and tolerability. MN-166 (ibudilast) showed a statistically significant 48% reduction in the rate of whole brain atrophy progression compared to placebo (p=0.04), measured by magnetic resonance imaging (MRI) analysis using brain parenchymal fraction (BPF), with no increased rate of serious adverse events in the MN-166 (ibudilast) group. In February 2018, we announced positive clinical efficacy trends from this trial regarding the secondary endpoint of confirmed disability progression.