MediciNova Awaits Patent for 2 Potential Treatments for IPF and Other Fibrotic Diseases


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IPF potential treatment

MediciNova received a notice of allowance for a new patent covering MN-001 (tipelukast) and MN-002 (a major metabolite of MN-001) for the treatment of fibrosis,  broadly defined as wide-ranging fibrosis or fibrotic diseases, affecting different organs and due to different etiologies, including pulmonary fibrosis.

Once issued by the U.S. Patent and Trademark Office (USPTO), the patent is expected to run until June 2035, and its allowed claims cover ways of inhibiting or treating fibrosis using MN-001 or MN-002.

MN-001 is an oral macromolecular formulation developed originally by Kyorin Pharmaceuticals. The drug primarily has an anti-fibrotic and anti-inflammatory action, and exerts its effects through several mechanisms, including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE), and inhibition of 5-lipoxygenase (5-LO). MN-001 also reduces the expression of genes that promote fibrosis and genes that promote inflammation.

MN-001 was initially designed to treat interstitial cystitis and asthma. The U.S. Food and Drug Administration (FDA) has approved it for fast-track development as a treatment for idiopathic pulmonary fibrosis (IPF), and fibrotic liver diseases including non-alcoholic steatohepatitis (NASH).

MediciNova is currently conducting a Phase 2 safety and tolerability study assessing MN-001 in IPF patients (NCT02503657), and another Phase 2 study evaluating MN-001 in NASH (NCT02681055).

“We are very pleased to receive notice that this new patent will be granted as the claims are broad enough to cover MN-001 for the treatment of many forms of fibrosis and fibrotic disease. We believe this patent could substantially increase the potential value of MN-001, as MN-001’s broad anti-fibrotic activity enables us to pursue clinical development in various types of fibrosis in addition to the ongoing clinical studies in NASH and IPF,” Yuichi Iwaki, MD, PhD, president and CEO of MediciNova, said in a recent press release.

Fibrosis is the formation of excess fibrous connective tissue in an organ or tissue in a reparative or reactive process. This can be a reactive, benign, or pathological state. In response to injury, fibrosis is called scarring, and fibrosis that arises from a single cell line is called a fibroma.