MediciNova Announces MN-001 (tipelukast) NASH/NAFLD Phase 2 Trial Interim Results Selected for Presentation at the International Liver Congress 2018 in Paris, France
Presentation details are as follows:
Title: The anti-fibrotic agent, tipelukast (MN-001) reduces serum triglyceride significantly in non-alcoholic steatohepatitis and non-alcoholic fatty liver disease patients with hypertriglyceridemia after 4 weeks of treatment, an interim analysis of ongoing clinical trial, MN-001-NATG-201
Session Date and Time: Friday, April 13, 2018 at
Session: Poster Session: NAFLD: Therapy
Location:
About the Trial
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.
About MN-001
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.
About
Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-221, MN-001, and MN-029. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-221, MN-001, and MN-029 and risks of raising sufficient capital when needed to fund
INVESTOR CONTACT:
Vice President
info@medicinova.com
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