MediciNova Announces Research Collaboration on MN-001 (tipelukast) with Juntendo University School of Medicine in Tokyo, Japan

MediciNova, Inc.

LA JOLLA, Calif., June 22, 2022 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company listed on the NASDAQ Global Market (Nasdaq: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (code number: 4875), today announced the initiation of a comprehensive research collaboration with Juntendo University, School of Medicine (2-1-1 Hongo, Bunkyo-Ku, Tokyo, Japan) to evaluate the mechanism of action of MN-001 (tipelukast) on lipid metabolism and metabolic syndrome.

The main collaborator is Takashi Mitsui MD, Ph.D., Professor and Chairman of the Department of Laboratory Medicine, a recognized expert in lipid metabolism who specializes in dyslipidemia and metabolic syndrome.

Kazuko Matsuda, MD, Ph.D., MPH, Medical Director of MediciNova, Inc, commented, “MN 001 is a new orally administered compound with multiple mechanisms, and its anti-fibrotic and anti-inflammatory effects have been observed in several animal model studies. It has also been observed to reduce serum triglyceride levels in patients with elevated serum triglyceride levels in several clinical trials conducted previously. In the Phase 2 trial in NASH/NAFLD patients with hypertriglyceridemia, MN-001 (tipelukast) reduced serum triglycerides, increased high-density lipoproteins (HDL-C), and reduced low-density lipoproteins ( LDL) during the 12-week treatment period. Additionally, improvements in serum lipid profile were more significant in patients with type 2 diabetes/prediabetes. We believe this research collaboration will provide new insights into the mechanism of action of MN-001 in the area of ​​lipid metabolism and metabolic syndrome and identify conditions that would benefit from MN-001 treatment.

About MN-001 (tipelukast)

MN-001 (tipelukast) is a novel, orally bioavailable, small-molecule compound thought to exert its effects through several mechanisms to produce its anti-inflammatory and anti-fibrotic activity in preclinical models, including the antagonism of leukotriene (LT) receptors, inhibition of phosphodiesterases (PDE) (mainly 3 and 4) and inhibition of 5-lipoxygenase (5-LO). The 5-LO/LT pathway has been postulated as a pathogenic factor in the development of fibrosis, and the inhibitory effect of MN-001 on 5-LO and 5-LO/LT pathway is a new approach to treat the fibrosis. MN-001 has been shown to downregulate the expression of genes that promote fibrosis, including LOXL2, collagen type 1, and TIMP-1. MN-001 has also been shown to downregulate the expression of genes that promote inflammation, including CCR2 and MCP-1. Additionally, MN-001 has been shown to inhibit triglyceride synthesis in hepatocytes by inhibiting arachidonic acid uptake.

About MediciNova

MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad portfolio of novel small molecule therapies for inflammatory, fibrotic and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3 ready for progressive multiple sclerosis ( SEP). MN-166 (ibudilast) has been studied in a phase 2 trial in patients at risk of developing acute respiratory distress syndrome (ARDS) and is also being evaluated in phase 2 trials for glioblastoma and drug addiction. substance. MN-001 (tipelukast) has been evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and is in preparation for a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD). MediciNova has a strong track record of obtaining investigator-sponsored clinical trials funded by government grants.

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. Such forward-looking statements include, but are not limited to, statements regarding the future development and effectiveness of MN-166, MN-001, MN-221 and MN-029. These forward-looking statements may be preceded, followed or otherwise include the words “believes”, “expects”, “anticipates”, “intends”, “estimates”, “projects”, “may”, “could”. ‘, ‘may’, ‘will’, ‘would’, ‘consider’, ‘plan’ 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 these forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the risks of obtaining a future partner or grant for the development of MN-166, MN-001, MN -221, and MN-029 and the risks of raising sufficient capital if needed to fund MediciNova’s operations and its contribution to clinical development, the risks and uncertainties inherent in clinical trials, including the potential cost, expected schedule, and risks associated with clinical trials designed to meet FDA requirements the direction and viability of further development considering these factors, the risks of developing and commercializing the product , uncertainty as to whether clinical trial results will be predictive of results at later stages of product development, risk of delay ds or failure to obtain or maintain regulatory approval, risks associated with the use of third parties to sponsor and fund clinical trials, risks regarding information, intellectual property rights in product candidates and the ability to defend and to enforce these intellectual property rights, the risk of default by third parties on which MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as intended, the risk of increased costs and delays due delays in the initiation, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of anticipated filings with regulatory authorities, MediciNova’s collaborations with third parties, the availability of funds to complete product development plans and the MediciNova’s ability to obtain third-party funding for the programs and to raise sufficient capital if needed, and the other risks and uncertainties described in MediciNova’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 202 1 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intention or obligation to revise or update these forward-looking statements.

Geoff O’Brien
vice president
MediciNova, Inc.
[email protected]

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