MediciNova Granted US Patent Approval for MN-001 in Liver Triglyceride Synthesis

LA JOLLA, Calif., Nov. 14, 2024 – MediciNova, Inc., a biopharmaceutical company listed on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), has announced the receipt of a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO). This notice pertains to a pending patent application for MN-001 (Tipelukast), covering a "Method to Decrease Triglyceride Synthesis in a Liver of a Subject." The allowed claims propose a method for reducing triglyceride synthesis in the liver by administering MN-001 (Tipelukast) or its metabolite or pharmaceutically acceptable salt. This method is particularly advantageous for individuals diagnosed with insulin resistance, pre-diabetes, or diabetes. The patent, upon issuance, is projected to expire no earlier than May 26, 2042.

Key elements of the patent include:
- Method: A technique to decrease triglyceride synthesis in the liver.
- Formulations: MN-001 (Tipelukast) can be administered in various forms.
- Administration: The compound can be administered orally in different formulations.
- Dosage Flexibility: The compound can be administered at various dosing frequencies.

Kazuko Matsuda, M.D., Ph.D., M.P.H., MediciNova’s Chief Medical Officer, commented on the achievement, stating, "We are excited to receive this Notice of Allowance, which underscores our commitment to developing innovative and proprietary treatments for metabolic disorders. This patent represents a significant advancement in our efforts to provide safe and effective therapies for patients with insulin resistance, pre-diabetes, and diabetes."

The Notice of Allowance is a significant step towards the issuance of the patent, providing MediciNova with intellectual property protection for this novel treatment method. This accomplishment highlights the company's dedication to advancing medical science and improving patient outcomes.

About MN-001:
MN-001 (Tipelukast) is a novel, orally bioavailable small molecule compound. It is believed to exert its effects through several mechanisms to produce anti-inflammatory and anti-fibrotic activity in preclinical models. These mechanisms include leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO). The 5-LO/LT pathway is considered a pathogenic factor in fibrosis development, and MN-001's inhibitory effect on this pathway is a novel approach to treating fibrosis. MN-001 has demonstrated the ability to down-regulate genes promoting fibrosis, such as LOXL2, Collagen Type 1, and TIMP-1. It also down-regulates genes that promote inflammation, including CCR2 and MCP-1. Furthermore, MN-001 inhibits triglyceride synthesis in hepatocytes by inhibiting arachidonic acid uptake.

About NAFLD, Type 2 Diabetes Mellitus (T2DM), and Hypertriglyceridemia:
Non-alcoholic fatty liver disease (NAFLD) is considered the hepatic manifestation of metabolic syndrome, with studies reporting that 50% of patients with metabolic syndrome also have NAFLD. Clinical and epidemiological evidence suggests that NAFLD is strongly associated with an increased prevalence and incidence of cardiovascular disease, T2DM, chronic kidney disease, and malignancy. The presence of dyslipidemia (hypercholesterolemia, hypertriglyceridemia, or both) is reported in 20-80% of NAFLD cases.

About MediciNova:
MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. The company focuses on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), which have multiple mechanisms of action and strong safety profiles. MediciNova has 11 programs in clinical development. Its lead asset, MN-166 (ibudilast), is in Phase 3 trials for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 is also being evaluated in Phase 2 trials for Long COVID and substance dependence. MN-001 (tipelukast) has been evaluated in a Phase 2 trial for idiopathic pulmonary fibrosis (IPF), with an ongoing Phase 2 trial for non-alcoholic fatty liver disease (NAFLD). MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.