FDA Approves MediciNova Protocol for Phase 2 Trial of Idiopathic Pulmonary Fibrosis Treatment


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shutterstock_127654082MediciNova, Inc. a biopharmaceutical company targeting the development of novel small-molecule treatments for conditions with unmet medical needs, recently announced that the U.S. Food and Drug Administration (FDA) approved their protocol for a new clinical trial of MN-001 (under the name tipelukast) as a potential therapeutic for patients with moderate to severe idiopathic pulmonary fibrosis (IPF).

Pulmonary fibrosis (PF) is a severe and progressive disease affecting the lungs that causes a permanent loss of lung tissue, which transports oxygen to the blood. Idiopathic pulmonary fibrosis (IPF) is one of the PF types, and is diagnosed when the cause of PF cannot be determined in a patient. Estimates from the Coalition for Pulmonary Fibrosis indicate that in the US, the disease affects nearly 128,000 individuals, with approximately 48,000 new diagnoses per year. IPF has a poor prognosis, with two-thirds of patients with the disease dying within five years of diagnosis.

MN-001 (tipelukast) is a bio-small molecule drug that was shown to produce 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). MN-001 has also been found to inhibit the effect on the 5-LO and 5-LO/LT pathway.

Evidence showed that MN-001 down-regulates gene expression that promotes fibrosis (specifically in the genes LOXL2, Collagen Type 1 and TIMP-1). The compound has also been found to down-regulate the expression of CCR2 and MCP-1, two genes implicated in inflammation. Moreover, data has shown that the compound was able to reduce fibrosis in animal models.

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A previous clinical trial in 600 patients with asthma showed that MN-001 has a good safety profile with minimal adverse effects. Based on these results, the FDA approved MediciNova’s Phase 2 study of MN-001 for IPF.

The approval from the FDA permitted an orphan-drug designation for MN-001 as a potential IPF treatment, providing MediciNova with seven years of exclusive marketing if MN-001 is eventually approved for IPF.

“We are very pleased that this important regulatory step is now completed, as we can now pursue clinical development of MN-001 in IPF,” commented Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc. in a recent news release.

The IPF protocol was filed under MediciNova’s open IND (Investigational New Drug Application) as part of the FDA’s Division of Pulmonary, Allergy, and Rheumatology Products (DPARP).