MediciNova Receives a Notice of Intention to Grant for a New Patent Covering MN-001 and MN-002 for the Treatment of Advanced NASH in Europe

LA JOLLA, Calif., Aug. 14, 2023 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced it has received a Notice of Intention to Grant from the European Patent Office for a pending patent application which covers MN-001 (tipelukast) and MN-002 (a major metabolite of MN-001) for the treatment of advanced nonalcoholic steatohepatitis (NASH).

Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than May 2035. The allowed claims cover MN-001 (tipelukast) or MN-002 for the treatment of a patient diagnosed with advanced NASH. The allowed claims also cover the treatment of advanced NASH patients that exhibit spider angiomata, ascites, splenomegaly, hard liver border, palmar erythema, asterixis, portal hypertension, hepatic scarring, cirrhosis, or hepatocellular carcinoma (HCC). In addition, the allowed claims cover MN-001 (tipelukast) or MN-002 for reducing hepatic fibrosis and hepatic scarring in a patient with advanced NASH. The allowed claims cover oral administration, including tablets and capsules, as well as liquid dosage forms. The allowed claims cover a wide range of doses of MN-001 (tipelukast) or MN-002 and a range of different dosing frequencies.

Kazuko Matsuda, M.D. Ph.D, MPH., Chief Medical Officer, MediciNova, Inc., commented, “We are very pleased to receive notice that this new patent will be granted as we believe it could increase the potential value of MN-001. We previously reported positive results from a Phase 2 clinical trial of MN-001 that enrolled NASH and NAFLD patients with hypertriglyceridemia. The U.S. FDA has granted Fast Track designation for MN-001 for the treatment of NASH with fibrosis. The U.S. Patent and Trademark Office previously granted a patent which covers MN-001 and MN-002 for advanced NASH with fibrosis and similar patents were granted in Japan, Korea, and Canada.”

About MN-001 (tipelukast)

MN-001 (tipelukast) is a novel, orally administered, small molecule compound with multiple mechanisms of action which has been in clinical development for the treatment of chronic inflammatory and fibrotic diseases, among others, due to its anti-inflammatory and anti-fibrosis effects. Based on the finding that MN-001 (tipelukast) reduces triglycerides (TG) in the blood from our previous clinical trials, we conducted a Phase 2 clinical trial in patients with hypertriglyceridemia and NASH or NAFLD. Based on the findings from the in-vitro mechanistic study of MN-001 (tipelukast), a subgroup analysis of the Phase 2 clinical trial showed a stronger improvement in lipid profile in the NASH/NAFLD patients with a history of diabetes. Therefore, a new Phase 2 clinical trial was initiated to investigate the effect of MN-001 (tipelukast) in NAFLD patients with type 2 diabetes and hypertriglyceridemia.