Date: 2015-01-28
Type of information: Clinical trial authorization
phase: 2
Announcement: clinical trial authorization
Company: Medicinova (USA - CA)
Product: MN-001 (tipelukast)
Action
mechanism: phosphodiesterase inhibitor/enzyme inhibitor. 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. Previously, MediciNova evaluated MN-001 for its potential clinical efficacy in asthma and had positive Phase 2 results. MN-001 has been exposed to more than 600 subjects and is considered generally safe and well-tolerated.
Disease: NASH (nonalcoholic steatohepatitis)
Therapeutic area: Liver diseases - Hepatic diseases
Country: USA
Trial details:
Latest
news: * On January 28, 2015, MediciNova announced that the IND (Investigational New Drug) Application for MN-001 (tipelukast) for the treatment of NASH (nonalcoholic steatohepatitis) has been accepted and is now open with the FDA. Importantly, due to safety data from previous clinical studies of MN-001, FDA has agreed that MediciNova may proceed with a Phase 2 study as the first clinical study of MN-001 in NASH.
