MediciNova, Inc. announced it has received a Decision to Grant from the European Patent Office for a new patent which covers MN-001 (tipelukast) for the treatment of scleroderma and/or systemic sclerosis. This patent is expected to expire no earlier than June 2035. The allowed claims cover a wide range of doses and a range of different dosing frequencies.

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 (tipel UKast) reduces triglycerides (TG) in the blood from previous clinical trials, the company 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. The molecular mechanism of action of MN-001 (tipelsukast) includes leukotriene receptor antagonism and inhibition of phosphodiesterase (mainly 3 and 4) and 5-lipoxygenase (5-LO) and these multiple mechanisms are believed to reduce inflammation and prevent fibrosis. In various animal models of fibrosis disease, MN-001 (tipelkast) has been shown to improve fibrosis on histopathological examination, and the FDA has granted Fast Track status to MN-001 (tipeluxast) for the treatment of NASH with fibrosis.

In the past, have conducted clinical trials for MN-001 (tipel Yukast) for the treatment of bronchial asthma and interstitial cystitis, and more than 600 patients have been treated with MN-001 (tipelakast) to date, confirming its good safety and tolerability profile.