MediciNova Inc has received FDA approval of the company’s protocol for a MN-001 (tipelukast) clinical trial to address moderate to severe idiopathic pulmonary fibrosis (IPF).
MN-001 (tipelukast) is an orally- and bio-available small molecule compound that has achieved both anti-inflammatory and anti-fibrotic activity in pre-clinical models including inhibition of 5-lipoxygenase (5-LO), inhibition of phosphodiesterases (PDE) and leukotriene (LT) receptor antagonism.
The MN-001’s inhibitory effect on 5-LO as well the 5-LO/LT pathway is considered a new approach to treat fibrosis. Further, it has been shown that MN-001 can down-regulate the expression of genes that promote inflammation including the MCP-1 and CCR2. Finally, histopathological data demonstrated that MN-001 reduces fibrosis in animal models.
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