MediciNova, Inc. announced that an abstract regarding an interim analysis from the ongoing Phase 2 clinical trial of MN-001 (tipelukast) in NASH/NAFLD patients has been accepted for poster presentation at the International Liver Congress 2018, the 53rd annual meeting of the European Association for the Study of the Liver (EASL), to be held April 11-15, 2018 in Paris, France. The Phase 2a trial is a multi-center, proof-of-principle, open-label study designed to evaluate the efficacy, safety, and tolerability of MN-001 in subjects with non-alcoholic steatohepatitis (NASH) or non-alcoholic fatty liver disease (NAFLD) with hypertriglyceridemia. Eligible subjects will consist of males and females ranging in age from 21 to 65 years old, inclusive. To be eligible, subjects must have a histologically confirmed diagnosis of NASH or imaging study confirmed NAFLD and an elevated serum triglyceride (>150 mg/dL) during the Screening Phase. Qualifying subjects will be given MN-001 250 mg orally administered once a day for the first 4 weeks and will be given MN-001 250 mg twice a day for an additional 8 weeks. Overall, the study timeline consists of a Screening Phase (up to 4 months) followed by a Treatment Phase (12 weeks), and a Follow-up visit (within 1 week after the last dose). The primary efficacy endpoints of the study are to evaluate the effect of MN-001 on 1) triglyceride levels in NASH or NALFD subjects with hypertriglyceridemia, and 2) cholesterol efflux capacity in NASH or NAFLD subjects with hypertriglyceridemia. Secondary endpoints include safety and tolerability of MN-001, PK profile of MN-001/MN-002 (by-product of MN-001), effects of MN-001 on HDL-C, LDL-C, and total cholesterol level, and effects of MN-001/002 on liver enzymes and percent fat in liver at Week 12. MN-001 (tipelukast) is a novel, orally bioavailable small molecule compound thought to exert its effects through several mechanisms to produce its anti-inflammatory and anti-fibrotic activity in preclinical models, including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO). The 5-LO/LT pathway has been postulated as a pathogenic factor in fibrosis development and MN-001's inhibitory effect on 5-LO and the 5-LO/LT pathway is considered to be a novel approach to treat fibrosis. MN-001 has been shown to down-regulate expression of genes that promote fibrosis including LOXL2, Collagen Type 1 and TIMP-1. MN-001 has also been shown to down-regulate expression of genes that promote inflammation including CCR2 and MCP-1. In addition, histopathological data shows that MN-001 reduces fibrosis in multiple animal models.