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Clinical Trials

MediciNova’s MN-001 meets primary end point in NASH / NAFLD study

PBR Staff Writer Published 02 April 2018

MediciNova said its MN-001 (tipelukast) has met its primary endpoint of reducing mean serum triglycerides in the phase 2 clinical trial of non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD) with hypertriglyceridemia.

The company said it will stop trial based on significant positive results from interim analysis.

According to the company, the MN-001 significantly reduced mean serum triglycerides, which is a primary endpoint, from 260.1 mg/dL before treatment to 185.2 mg/dL after eight weeks of treatment.

The firm has decided to discontinue recruitment of patients and terminate the study to further accelerate the development of MN-001.

The phase 2a is a multi-center, proof-of-principle and open-label study designed to assess the efficacy, safety, and tolerability of MN-001 in subjects with NASH or non-alcoholic fatty liver disease (NAFLD) with hypertriglyceridemia.

MediciNova recruited subjects, including males and females aged between 21 and 65 years old.

MN-001 is a novel and orally bioavailable small molecule compound, which is believed to exercise its effects through various 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

MN-001 was demonstrated to down-regulate expression of genes, including LOXL2, Collagen Type 1 and TIMP-1, which advance fibrosis. In addition, histopathological data demonstrated that MN-001 decreased fibrosis in various animal models.

MediciNova president and CEO Dr Yuichi Iwaki said: "We are thrilled with the results of this study, which showed a large reduction in triglycerides.

“Based on the results of this study, along with the triglyceride data we have from prior clinical studies of MN-001 in other indications, we believe that MN-001 has potential to benefit a wide range of patients with hypertriglyceridemia, not limited to those with NASH and NAFLD.”

Image: Micrograph of non-alcoholic fatty liver disease. Photo: courtesy of Nephron.