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MediciNova Announces Initiation of a Phase 2 Trial of MN-001 (tipelukast) in NAFLD with Type 2 Diabetes Mellitus and Hypertriglyceridemia
LA JOLLA, Calif., July 26, 2022 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq: MNOV) and the
About this update from Medicinova, Inc.
[{"type":"text","content":"LA JOLLA, Calif., July 26, 2022 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced the initiation of 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. Kazuko Matsuda, MD, PhD, Chief Medical Officer of MediciNova, Inc., 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.\" About the NAFLD with Type 2 Diabetes Mellitus and Hypertriglyceridemia Trial This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of MN-001 (tipelukast) in patients with NAFLD, T2DM and hypertriglyceridemia. The design of the Phase 2 clinical trial includes the following elements: Approximately 40 male and female patients, ages 21 to 75 years, in the U.S.Patients will be randomized 1:1 to receive either 500 mg/day of MN-001 (tipelukast) or placebo for 24 weeks.The co-primary endpoints are (1) change from baseline in liver fat content measured by MRI Proton Density Fat Fraction (MRI-PDFF) at Week 24, and (2) change from baseline in fasting serum triglycerides at Week 24. MRI-PDFF is a non-invasive, quantitative, and accurate measure of liver fat content commonly used in early phase trials to measure treatment response.Secondary endpoints include safety and tolerability and changes in lipid profile (HDL-C, LDL-C, and total cholesterol). About NAFLD, Type 2 Diabetes Mellitus, and Hypertriglyceridemia NAFLD is considered the hepatic manifestation of metabolic syndrome; studies have reported that 50% of patients with metabolic syndrome also have NAFLD. There is sufficient clinical and epidemiological evidence supporting the assertion that NAFLD is strongly associated with an increased prevalence and incidenc...