MediciNova Commences Mid-Stage Non-alcoholic Fatty Liver Disease Study

MediciNova MNOV initiated a Phase 2 clinical trial to evaluate MN-001 (tipelukast) for the treatment of patients with non-alcoholic fatty liver disease (NAFLD), type 2 diabetes mellitus (T2DM), and hypertriglyceridemia.

The Phase 2 clinical trial is designed to evaluate the efficacy and safety of MN-001 (tipelukast) in patients with NAFLD, T2DM and hypertriglyceridemia.

The company will enrol 40 male and female patients, ages 21 to 75 years, the subjects will receive either 500 mg/day of MN-001 (tipelukast) or placebo for 24 weeks.

Kazuko Matsuda, Chief Medical Officer, commented, "We are very pleased that this Phase 2 trial evaluating MN-001 has commenced. MN-001 appears to reduce serum lipid profiles in patients with a dual diagnosis of NAFLD and T2DM/prediabetes with dyslipidemia. The efficacy and safety data from this trial, if successful, could lead to a pivotal Phase 3 trial intended to support an NDA for MN-001 to treat dyslipidemia and reduce liver fat content in patients with NAFLD with T2DM/prediabetes.”

NAFLD is considered the hepatic manifestation of metabolic syndrome; studies have reported that 50% of patients with metabolic syndrome also have NAFLD.

Price Action : MediciNova shares are trading around 4 percent higher at $2.49 on Tuesday at the time of publication.