Feb. 17, 2020: MediciNova announced that it has received a Notice of Allowance from the Japan Patent Office for a pending patent application which covers MN-001 (tipelukast) and MN-002 (a chief metabolite of MN-001) for the treatment of advanced non-alcoholic steatohepatitis (NASH).Â
The patent maturing from this approved patent application is scheduled to expire no earlier than May 2035 upon issuance. The permissible statements cover MN-001 and MN-002 for use in treating an advanced NASH patient.
Advanced patients with hepatic fibrosis, spider angiomata, ascites, splenomegaly, hard liver border, palmar erythema, asterixis, portal hypertension, hepatic scarring, cirrhosis, or hepatocellular carcinoma (HCC) are also covered by the permitted claims. Furthermore, the permissible claims cover MN001 and MN 002 for use in hepatic fibrosis reduction and for use in patients with reduced hepatic scarring. The allowed claims include oral administration, including tablets and capsules, as well as liquid dosage forms. MN 001 (tipelukast) is a novel, orally bioavailable small molecule compound thought to exert its effects in preclinical models through several mechanisms to achieve its anti-inflammatory and anti fibrotic action, including leukotriene (LT) receptor antagonism, phosphodiesterase inhibition (PDE) (mainly 3 and 4) and 5-lipoxygenase inhibition (5-LO).
The 5 LO / LT pathway was postulated as a pathogenic factor in the development of fibrosis, and the inhibitory effect of MN 001 on 5 LO and the 5 LO / LT pathway is considered a novel approach to fibrosis treatment. MN-001 has been shown to down-regulate the fibrosis-promoting gene expression including LOXL2, Collagen Type 1 and TIMP-1.
https://investors.medicinova.com/news-releases/news-release-details/medicinova-receives-notice-allowance-new-patent-covering-mn-17
