MediciNova, Inc. (MNOV)

[Raffis]

About MN-001 Positive Phase 2 Results
“MN-001 (tipelukast) is a novel, orally bioavailable small molecule compound which exerts its effects through several mechanisms to produce its anti-fibrotic and anti-inflammatory 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 considered generally safe and well-tolerated.”
https://medicinova.com/clinical-development/core/mn-001-nash/

Development Plans

Recent preclinical results provide compelling evidence that MN-001 warrants further evaluation for the treatment of NASH in humans. MediciNova has an open IND at FDA. Due to safety data from previous clinical studies of MN-001, FDA has approved the protocol for a Phase 2 study as the first clinical trial of MN-001 in NASH.
https://medicinova.com/clinical-development/core/mn-001-nash/liver-fibrosis/