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news.The US Food and Drug Administration (FDA) has accepted MediciNova's investigational new drug (IND) application for its orally bioavailable small molecule compound, MN-001 (tipelukast), to treat nonalcoholic steatohepatitis (NASH), a common liver disease.
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MN-001 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), and inhibition of 5-lipoxygenase (5-LO).
The FDA approval was based on safety data from previous clinical studies of the drug candidate, to proceed with a Phase II trial as the first clinical study of MN-001 in NASH.
MediciNova president and CEO Yuichi Iwaki said: "We are very pleased that this important regulatory step is now completed, as we can now pursue clinical development of MN-001 in NASH or other liver diseases."
The company said that the 5-LO/LT pathway has been assumed 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 new 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 as well as promote inflammation including CCR2 and MCP-1.
Additionally, histopathological data shows that MN-001 reduces fibrosis in multiple animal models.
Earlier, the company has evaluated MN-001 for its potential clinical efficacy in asthma and had positive Phase II results.