La Jolla, Calif., March 12, 2024 (Globe Newswire) — MediciNova, Inc. is a biopharmaceutical company traded on the Nasdaq Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875). Today, MediciNova co-investigators Perenley Enkhbaatar, MD, FAHA, professor of anesthesiology, director of the Translational Intensive Care Unit, and Charles Robert Allen, professor of anesthesiology at the University of Texas Medical Branch, announced new data from non-clinical trials. announced that the results had been announced. Study evaluating MN-166 (ibudilast) in the chlorine gas-induced acute lung injury (CIALI) model at the Society of Toxicology (SOT) 63rd Annual Meeting and ToxExpo in Salt Lake City, Utah.
The primary objective of this non-clinical efficacy study was to determine the safety and pharmacological activity of MN-166 (ibudilast) after chlorine (Cl)-induced ALI.2) Gas inhalation in a clinically relevant translational sheep model. This study evaluated single-dose and multi-dose treatments. The primary endpoint was mean change in pulmonary function measure PaO.2/FiO2, which is the ratio of the arterial oxygen partial pressure to the inspired oxygen partial pressure. Additional endpoints include survival, lung mechanics, lung injury, and edema formation as assessed by chest X-ray.
Highlights of the presentation entitled “Evaluation of the safety and pharmacological activity of MN-166 (ibudilast) in a clinically relevant ovine model of chlorine-induced acute lung injury” (Abstract No. 4296) include:
After Cl2 Gas challenge (210 ppm x 30 min) to induce moderate ALI (average PaO)2/FiO2subjects were randomly assigned to four treatment groups: MN-166 (ibudilast) low dose (10 mg) or high dose (20 mg), positive control (rolipram 1 mg), and vehicle ( Negative control)). Cl2 At a gas concentration of 210 ppm x 30 min, mortality was expected to be 20-30% (Fukuda 2015).
Treatment plan:
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Single-dose treatment (n=5/group) with only one 30-minute IV infusion was started 30 minutes after CI completion.2 challenge
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Multi-dose treatment with a total of 4 30-minute IV infusions (n=3/group). Starts 30 minutes after completion of Cl.2 Gas challenge, then every 12 hours
Efficacy results
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Single dose treatment
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Multiple dose treatment
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MN-166 (ibudilast) 20 mg showed significant improvement in mean PaO2/FiO2 (p=0.0001), the animal recovered to such an extent that it no longer met the criteria for ARDS (Berlin ARDS Definition 2012)
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MN-166 (ibudilast) 20 mg also showed lower peak airway pressure (p<0.05), plateau airway pressure (p<0.05), pulmonary artery pressure (p<0.05), and lung injury score (p<0.05). showed a significant improvement when compared.To other treatment groups
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MN-166 (ibudilast) 20 mg also preserved heart and kidney function compared to other treatment groups.
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Of note, significance was observed beyond the T=12 hour time point, further reinforcing the observed benefit of MN-166 (ibudilast) 20 mg with the multiple-dose treatment regimen.
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survival
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MN-166 (ibudilast) 20 mg treatment showed a higher survival benefit than other treatment groups. All animals (8 of 8) in the MN-166 (ibudilast) 20 mg group survived the 48-hour monitoring period, whereas 25% (2 of 8/arm) of the other groups survived the 48-hour monitoring period. They were euthanized early when death criteria were reached. .
Kazuko Matsuda, MD, MPH, Chief Medical Officer of MediciNova, Inc., commented: In the sheep CIALI model study, ARDS disease duration was longer, lung damage was reduced, and survival was higher. Taken together, the positive results obtained from this clinically relevant ovine model, a previously reported non-clinical model of lipopolysaccharide (LPS)-induced ARDS, and the novel coronavirus in hospitalized patients at risk of developing ARDS. We believe that MN-166 (ibudilast) is a promising candidate for ALI in clinical trials in patients with viral infections. ”
This project is funded in whole or in part by federal funds from the Department of Health and Human Services. Management for strategic preparedness and response. Biomedical Advanced Research and Development Authority, Contract No. 75A50121C00022.
About MN-166 (ibudilast)
MN-166 (ibudilast) is a small molecule compound that inhibits inflammatory cytokines such as phosphodiesterase type 4 (PDE4) and macrophage migration inhibitory factor (MIF). It is in late stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy). It is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorders. Additionally, MN-166 (ibudilast) was evaluated in patients at risk of developing acute respiratory distress syndrome (ARDS).
About Meditinova
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. Based on his two compounds, MN-166 (ibudilast) and his MN-001 (tipelukast), with multiple mechanisms of action and a strong safety profile, MediciNova has 11 clinical development programs . MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM), and is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM). is ready for Phase 3 for patients with MS (MS). MN-166 (ibudilast) is also being evaluated in a long-term COVID and substance dependence Phase 2 trial. MN-001 (tipelukast) is being evaluated in a Phase 2 study in idiopathic pulmonary fibrosis (IPF) and progressing in a second Phase 2 study in non-alcoholic fatty liver disease (NAFLD) It’s inside. MediciNova has a strong track record of securing physician-sponsored clinical trials funded through 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. These forward-looking statements include, without limitation, statements regarding future developments. Efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements are preceded by the words “believes,” “expects,” “anticipates,” “intends,” “estimates,” “plans,” “could,” “could,” It may be followed by or included. “may,” “will,” “will,” “considering,” “planning,” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Masu. Factors that could cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include the risks of acquiring future partners, MN-166, MN-001 , including, but not limited to, the risk of obtaining grant funding for the development of MN. -221, MN-029, and the risks of raising sufficient capital when necessary to fund MediciNova’s operations and clinical development contributions, potential associated with clinical trials designed to meet the FDA. risks and uncertainties inherent in clinical trials, including cost, expected timing and risks; guidance and feasibility of further development in light of these factors; risks of product development and commercialization; uncertainties about the predictability of outcomes in late stages of product development; risks of delays or failures in obtaining or maintaining regulatory approval; and related to reliance on third parties to sponsor and fund clinical trials; risks related to the intellectual property rights of the product candidates and the ability to defend and enforce such intellectual property rights; risks of failure of third parties on which MediciNova relies to conduct clinical trials; risks of increased costs and delays due to delays in completion, analysis, or significant issues with the design of the clinical trial or the appropriateness of the conduct of the clinical trial; the expected timing of regulatory filings; MediciNova’s collaboration with third parties; , the availability of funds to complete its product development plans, MediciNova’s ability to obtain third-party funding for its programs and raise sufficient capital, if necessary, and other risks and uncertainties. , MediciNova to the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2023, subsequent periodic reports on Form 10-Q and current reports on Form 8-K. is stated in the submitted documents. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. MediciNova disclaims any intention or obligation to revise or update these forward-looking statements.
Investor contact information:
Geoff O’Brien
vice president
Medicinova Co., Ltd.
info@medicinova.com
