MediciNova, Inc., a biopharmaceutical company, recently announced that the FDA (U.S. Food and Drug Administration) has approved thecompany’s protocol for a MN-001 (tipelukast) clinical trial to address moderate to severe idiopathic pulmonary fibrosis (IPF). Supported by previous safety data from other clinical studies of MN-001, the FDA granted MediciNova clearance to proceed the first Phase 2 study of MN-001 for IPF, under MediciNova’s open IND (Investigational New Drug Application). Once the FDA grants the drug final approval, the orphan drug designation provides 7 years of commercializing exclusivity to MediciNova.
The CEO and president of MediciNova, Dr. Yuichi Iwaki, commented in a press release: “We are very pleased that this important regulatory step is now completed, as we can now pursue clinical development of MN-001 in IPF.”
MN-001 (tipelukast) is an orally- and bio-available small molecule compound that achieves its therapeutic effects through various mechanisms to achieve 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.
MN-001 has been previously assessed by MediciNova for asthma and it obtained good Phase 2 results. The compound has been exposed to more than 600 individuals and safety and tolerance have been satisfactory.
Notes About MediciNova
MediciNova is a biopharmaceutical company focused on advancing new therapeutic approaches through small-molecule therapeutics to address diseases with unmet medical needs. The company’s leading strategies are comprised of MN-166 (ibudilast) to address multiple sclerosis, amyotrophic lateral sclerosis and substance addiction and MN-001 (tipelukast) to address nonalcoholic steatohepatitis, idiopathic pulmonary fibrosis and other fibrotic disease. Finally, MN-221 (bedoradrine) to treat acute exacerbations caused by asthma and MN-029 (denibulin) to treat solid tumor cancers are other projects that MediciNova is developing. More information is available in www.medicinova.com.
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