MediciNova Announces Positive Results Of MN-001 In Advanced NASH Mouse Model; MediciNova Requests A Meeting With FDA

MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market

and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced positive results from a second preclinical study that examined the potential clinical efficacy of MN-001 for the treatment of advanced NASH (nonalcoholic steatohepatitis with fibrosis). This study used mice in more advanced stages of NASH as compared to the first study of MN-001 in a NASH mouse model. MN-001 administered orally once daily (10, 30, and 100 mg/kg) for 4 weeks, was evaluated in the STAM™ (NASH-HCC) mouse model of advanced NASH, as measured by histopathology, NAFLD activity score (NAS) and percent of fibrosis. MN-001 showed anti-NASH and anti-fibrotic effects in the advanced NASH mouse model. NAFLD activity score was significantly reduced in the MN-001 treated group compared to the non-treated group (p<0.001). The reduction was observed consistently in all NAS components including hepatocyte ballooning score (p<0.001), lobular inflammation score (p<0.01), and steatosis score (p<0.05). Percent fibrosis area was also reduced in the MN-001 treated group (p<0.01). In addition, alpha-SMA-positive staining area was significantly reduced in the MN-001 treated group (p<0.001). Based on these results in addition to the results of the first NASH mouse model study reported on January 14, 2014, MediciNova requested a meeting with FDA to finalize the trial design for a clinical study of MN-001 in NASH patients.