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MediciNova Announces New Data and Results of MN-166 (ibudilast) in Chlorine Gas-induced Acute Lung Injury Presented at the 63rd Annual Meeting of the Society of Toxicology

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MediciNova, Inc. announces positive results from a nonclinical study evaluating MN-166 (ibudilast) in a chlorine gas-induced acute lung injury model. MN-166 showed significant improvements in pulmonary function, survival rates, and lung injury attenuation. The study highlighted the efficacy of MN-166 in treating acute lung injury, positioning it as a promising candidate for further development.
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The recent findings from MediciNova's nonclinical study on MN-166 (ibudilast) have indicated a significant improvement in pulmonary function and survival rates in an ovine model of chlorine-induced acute lung injury (CIALI). The data suggest that MN-166 could be a promising therapeutic agent for acute lung injury (ALI), which is a condition with high morbidity and mortality rates. From a medical research perspective, the ability of MN-166 to improve PaO2/FiO2 ratios—a critical measure of lung function—and reduce lung injury scores is a noteworthy outcome, potentially positioning the drug as an effective treatment for conditions like ARDS, a severe form of lung injury.

Furthermore, the multi-dose regimen's success in maintaining cardiac and kidney function is significant, as these organs can be adversely affected during severe lung injury. The fact that this study was funded by the Biomedical Advanced Research and Development Authority (BARDA) adds credibility to the research, given BARDA's role in supporting the development of treatments for public health emergencies. The transition from positive nonclinical results to clinical efficacy is not always guaranteed, but the alignment with previous positive clinical trial data in COVID-19 patients suggests a potential for MN-166 to progress through the drug development pipeline effectively.

Investors in the biopharmaceutical sector pay close attention to nonclinical study results, as they can be early indicators of a drug's potential market success. In the case of MediciNova's MN-166, the positive outcomes from the CIALI model study may influence investor sentiment and the company's stock valuation. The drug's efficacy in improving crucial lung function parameters and survival rates could lead to an expansion of its therapeutic applications, potentially tapping into a significant market for ALI and ARDS treatments.

The involvement of federal funding from BARDA underlines the strategic importance of MN-166 and could lead to further government support or expedited regulatory processes. For MediciNova, the progression of MN-166 through clinical trials may attract partnership opportunities, licensing deals, or even acquisition interest from larger pharmaceutical companies seeking to bolster their respiratory treatment portfolios. The long-term financial implications for MediciNova hinge on the drug's continued success in clinical trials and eventual market approval, which would be a substantial value driver for the company.

Acute lung injury and its more severe form, acute respiratory distress syndrome (ARDS), represent areas of significant unmet medical need. The current standard of care primarily involves supportive treatments, such as mechanical ventilation, which underscores the demand for pharmacological interventions that can improve patient outcomes. The positive results of MN-166 in a clinically relevant ovine model could signal a shift in the treatment landscape for ALI and ARDS, especially if the drug's benefits are replicated in human clinical trials.

Considering the global incidence of ALI and ARDS, which can arise from various causes including infections, trauma and inhalation injuries, the market potential for an effective treatment like MN-166 is considerable. The drug's development is also timely, given the heightened awareness of respiratory illnesses in the post-COVID-19 era. Market research would focus on identifying the potential size of the target population, competitive landscape, pricing strategies and reimbursement scenarios to assess the commercial viability of MN-166.

LA JOLLA, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that MediciNova’s collaborator, Perenlei Enkhbaatar, MD, PhD, FAHA, Professor, Department of Anesthesiology, Director, Translational Intensive Care Unit, Charles Robert Allen Professor in Anesthesiology, University of Texas Medical Branch, presented new data and results of a nonclinical study evaluating MN-166 (ibudilast) in a 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 nonclinical efficacy study was to determine the safety and pharmacological activity of MN-166 (ibudilast) following ALI induced by chlorine (Cl2) gas inhalation in a clinically relevant translational ovine model. In this study, single-dose and multi-dose treatments were evaluated. The primary endpoint was the mean change in the pulmonary function measure PaO2/FiO2, which is the ratio of arterial oxygen partial pressure to fractional inspired oxygen. Additional endpoints included survival, lung mechanics, lung injury, and edema formation evaluated by chest x-ray.

The highlights of the presentation, entitled “Evaluation of safety and pharmacological activity of MN-166 (ibudilast) in a clinically relevant ovine model of chlorine-induced acute lung injury” (Abstract # 4296), are as follows:

After a Cl2 gas challenge (210 ppm x 30 min) to induce moderate ALI (mean PaO2/FiO2<200 mmHg), the test subjects were randomly assigned to 4 treatment groups: MN-166 (ibudilast) low dose (10 mg) or high dose (20 mg), a positive control (rolipram 1 mg), and vehicle (negative control). Cl2 gas concentration of 210 ppm x 30 min was expected to result in a 20 - 30% mortality rate (Fukuda 2015).

Treatment regimens:

  • Single-dose treatment (n=5/group) in which a 30-min IV infusion was given once only, initiated 30 min after completion of the Cl2 challenge
  • Multi-dose treatment (n=3/group) in which 30-min IV infusions were given a total of 4 times, initiated 30 min after the completion of Cl2 gas challenge, then every 12 hours

Efficacy Result

  • Single-dose treatment
    • MN-166 (ibudilast) 20 mg and rolipram treatment resulted in greater improvement in mean PaO2/FiO2 and peak airway pressure but dissipated after Hour 12
  • Multi-dose treatment
    • MN-166 (ibudilast) 20 mg showed greater improvement in mean PaO2/FiO2 ratio (p=0.0001), with animals recovering enough to no longer meet the criteria of ARDS (Berlin ARDS definition 2012)
    • MN-166 (ibudilast) 20 mg also showed greater improvement in 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) compared to the other treatment groups
    • MN-166 (ibudilast) 20 mg also maintained cardiac and kidney function compared to the other treatment groups
    • Notably, significance was observed beyond the T=12-hour timepoint, further reinforcing the observed benefit of MN-166 (ibudilast) 20 mg with the multi-dose treatment regimen

Survival

  • MN-166 (ibudilast) 20 mg treatment demonstrated a greater survival benefit than the other treatment groups. All animals in the MN-166 (ibudilast) 20 mg group (8 out of 8) survived the 48-hour monitoring period, while 25% (2 out of 8 / arm) animals were euthanized early in other groups upon reaching the euthanasia criteria.

Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, "We are very pleased to report the positive results in which MN-166 demonstrated a large and significant improvement in pulmonary function and recovery, i.e., no longer having ARDS, attenuation of lung injury, and a higher survival rate in the ovine CIALI model study. Collectively, positive findings from this clinically relevant ovine model, the previously reported lipopolysaccharide (LPS)-induced ARDS nonclinical model, and significant positive results from a clinical trial in hospitalized COVID-19 patients at risk of developing ARDS, we believe MN-166 (ibudilast) shows promise as a candidate for ALI.”

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50121C00022.

About MN-166 (ibudilast)

MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including 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); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).   

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. 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 (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-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 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 MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, 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 expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when 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, 2023 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 intent or obligation to revise or update these forward-looking statements.

INVESTOR CONTACT:

Geoff O'Brien
Vice President
MediciNova, Inc.
info@medicinova.com


FAQ

What is the primary objective of the nonclinical study presented by MediciNova?

The primary objective was to determine the safety and pharmacological activity of MN-166 (ibudilast) in a chlorine gas-induced acute lung injury model.

What were the primary endpoints of the study?

The primary endpoint was the mean change in the pulmonary function measure PaO2/FiO2 ratio. Additional endpoints included survival, lung mechanics, lung injury, and edema formation.

What were the treatment regimens evaluated in the study?

The study evaluated single-dose treatment and multi-dose treatment of MN-166 (ibudilast) following ALI induced by chlorine gas inhalation.

What were the key efficacy results of the study?

MN-166 (ibudilast) 20 mg showed significant improvement in mean PaO2/FiO2 ratio, peak airway pressure, and other parameters compared to other treatment groups.

What was the survival benefit observed in the study?

MN-166 (ibudilast) 20 mg treatment demonstrated a greater survival benefit, with all animals in the group surviving the 48-hour monitoring period.

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