MediciNova Receives a Notice of Allowance for a New Patent Covering MN-001 and MN-002 for the Treatment of Scleroderma and Systemic Sclerosis in Canada
Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than June 2035. The allowed claims cover the use of MN-001 (tipelukast) or MN-002 for treating scleroderma and/or systemic sclerosis and for reducing and/or inhibiting elevated hydroxyproline levels in scleroderma/systemic sclerosis. The allowed claims cover oral administration including liquid and solid dosage forms (tablets or capsules). The allowed claims cover a wide range of doses and a range of different dosing frequencies.
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.
The molecular mechanism of action of MN-001 (tipelukast) 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. We have also confirmed that MN-001 (tipelukast) suppresses fibrosis-promoting genes such as LOXL2, Collagen Type 1, and TIMP-1 and suppresses inflammation-promoting genes such as CCR2 and MCP-1 in a fibrosis disease model study. Although the direct mechanism of action of MN-001 (tipelukast) on TG reduction in blood has not yet been fully clarified, we are conducting joint research with
In various animal models of fibrosis disease, MN-001 (tipelukast) has been shown to improve fibrosis on histopathological examination, and the FDA has granted Fast Track status to MN-001 (tipelukast) for the treatment of NASH with fibrosis. MN-001 (tipelukast) has also been granted Fast Track status and Orphan Drug designation for the treatment of idiopathic pulmonary fibrosis. In the past, we have conducted clinical trials for MN-001 (tipelukast) for the treatment of bronchial asthma and interstitial cystitis, and more than 600 patients have been treated with MN-001 (tipelukast) to date, confirming its good safety and tolerability profile.
Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by, or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund
Source: MediciNova, Inc.
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