MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), has been granted a Notice of Allowance by the Canadian Intellectual Property Office for a pending patent application. This patent covers MN-001 (tipelukast) and MN-002 (a major metabolite of MN-001) for the treatment of scleroderma and/or systemic sclerosis. This is an exciting milestone for the company, paving the way for the potential use of MN-001 and MN-002 in treating these debilitating autoimmune diseases.
The groundbreaking patent, maturing from an allowed patent application, is set to expire no earlier than June 2035. It covers the use of MN-001 (tipelukast) and MN-002 for treating scleroderma and/or systemic sclerosis, as well as reducing and/or inhibiting elevated hydroxyproline levels in scleroderma/systemic sclerosis. The patent covers oral administration of both liquid and solid dosage forms, such as tablets or capsules, with a wide range of doses and dosing frequencies. This patent is a major step forward in providing effective treatment and care for those suffering from scleroderma and systemic sclerosis.
We are delighted to announce that MediciNova, Inc. has been awarded a new patent in Canada based on the positive results of a systemic sclerosis animal model study. According to Dr. Kazuko Matsuda, M.D. Ph. D., M.P.H., Chief Medical Officer for MediciNova, Inc., this patent approval could further increase the potential value of MN-001.
About MN-001 (tipelukast)
MN-001 (tipelukast) is an innovative, orally administered, small molecule compound with multiple mechanisms of action. Our prior clinical trials revealed that MN-001 (tipelukast) decreases triglycerides in the blood, leading us to conduct a Phase 2 clinical trial in patients with hypertriglyceridemia and NASH or NAFLD. A subgroup analysis of this trial showed an even greater improvement in lipid profile in NASH/NAFLD patients with a history of diabetes, prompting us to launch an additional Phase 2 clinical trial to further explore the impact of MN-001 (tipelukast) in NAFLD patients with type 2 diabetes and hypertriglyceridemia.
MN-001 (tipelukast) is a promising new drug which works through multiple mechanisms to reduce inflammation and prevent fibrosis. Our research has shown that it suppresses fibrosis-promoting genes such as LOXL2, Collagen Type 1, and TIMP-1, as well as inflammation-promoting genes such as CCR2 and MCP-1. We are eager to uncover the direct mechanism of action that makes MN-001 (tipelukast) so effective in reducing blood TG levels, and are working with Juntendo University to do so.
MN-001 (tipelukast) has been granted Fast Track status and Orphan Drug designation for the treatment of NASH with fibrosis and idiopathic pulmonary fibrosis, and these designations have been backed up by multiple animal models that have shown it to be effective in improving fibrosis. What’s more, our clinical trials have proven that MN-001 (tipelukast) is safe and well-tolerated, with over 600 patients having been treated with it thus far.
MediciNova is a clinical-stage biopharmaceutical company on a mission to develop effective treatments for inflammatory, fibrotic, and neurodegenerative diseases. With two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), MediciNova is leading the charge in late-stage drug development. MN-166 is already in Phase 3 for ALS and DCM and ready for Phase 3 testing for MS, while MN-001 is being evaluated for IPF and NAFLD in Phase 2 trials. MediciNova is also well-known for successfully securing investigator-sponsored clinical trials funded by government grants.