MediciNova Announces Initiation of a Phase 2 Trial of MN-001 (tipelukast) in NAFLD with Type 2 Diabetes Mellitus and Hypertriglyceridemia
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
- 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 incidence of cardiovascular disease, T2DM, chronic kidney disease, and malignancy. The presence of dyslipidemia (hypercholesterolemia, hypertriglyceridemia, or both) is reported in 20 - 80% of NAFLD cases.
About MN-001 (tipelukast)
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 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, MN-001 was found to inhibit triglyceride synthesis in hepatocytes by inhibiting arachidonic acid uptake.
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-001, MN-221, 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-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund
Source: MediciNova, Inc.
View printer-friendly version