A Phase Ib Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of Repeated Administration, Intravenous MN-221 in Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients

In MediciNova's clinical development plan for MN-221, it was recognized that treatment of COPD exacerbations may necessitate more than one single i.v. infusion and that patients in this population may have more co-morbidities (and concomitant medications) than has been generally studied so far. Thus, the primary objective of this clinical study is to determine the repeated administration safety and tolerability of intravenous (i.v.) MN-221 compared to placebo with repeated administration over several days in moderate to severe COPD patients who may also have co-morbidities and concomitant medications (CM) common in this population. Secondary outcomes include pharmacokinetics (PK) and preliminary efficacy (FEV1).
This Phase 1b trial follows naturally upon a Phase 1b COPD trial completed last year (MN-221-CL-010) and is additionally well-supported by relevant animal safety data and human clinical trial information.

Start Date01 Mar 2012

Sponsor / Collaborator

MediciNova, Inc.

NCT01013142 / CompletedPhase 1

A Phase I Randomized, Double-blind, Placebo-controlled Dose Escalation Study to Evaluate the Safety and Efficacy of MN-221 When Administered Intravenously to Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The objective of this clinical study is to determine the safety of intravenous MN-221 compared to placebo when administered in subjects diagnosed with stable moderate to severe COPD.

Start Date01 Nov 2009

Sponsor / Collaborator

MediciNova, Inc.

NCT00838591 / CompletedPhase 2

MN-221-CL-007: A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MN-221 When Administered Intravenously as an Adjunct to Standard Therapy to Adults With an Acute Exacerbation of Asthma

The objective of this clinical study is to examine the safety and effectiveness of intravenous MN-221 compared to placebo when administered as an adjunct to standard therapy in subjects experiencing an acute exacerbation of asthma.

Start Date01 Mar 2009

Sponsor / Collaborator

MediciNova, Inc.

100 Clinical Results associated with Bedoradrine Sulfate

100 Translational Medicine associated with Bedoradrine Sulfate

100 Patents (Medical) associated with Bedoradrine Sulfate

Literatures (Medical) associated with Bedoradrine Sulfate

01 Oct 2015·Respiratory medicineQ3 · MEDICINE

Efficacy of a new intravenous β 2 -adrenergic agonist (bedoradrine, MN-221) for patients with an acute exacerbation of asthma

Q3 · MEDICINE

Article

Author: Lewis, Lawrence M ; Matsuda, Kazuko ; Iwaki, Yuichi ; O'Brien, Geoffrey ; Makhay, Malath ; Ferguson, Ian ; House, Stacey L ; Lovato, Luis M

BACKGROUND:

Many patients with acute exacerbation of asthma are non-responders to inhaled β-adrenergic agonists. The goal of this study was to evaluate the safety and efficacy of intravenous bedoradrine (MN-221), a highly selective β2-adrenergic agonist, as adjunct to standard therapy in the management of patients with acute exacerbation of asthma who did not respond to standard therapy.

METHODS:

Patients (N = 167) received standard therapy and were randomized to either bedoradrine (1200 μg) or placebo. Safety and efficacy parameters were monitored hourly for 3 h, followed by a 24-h follow-up visit and an 8-day follow-up phone call. Change in %FEV1 from baseline to Hour 3 was the primary outcome. Secondary outcome measures included change in %FEV1 at 1 and 2 h, change in dyspnea score at 1, 2, and 3 h, treatment failure rate, defined as a combination of hospitalization on the index visit or return to the emergency department within 1 week, and safety monitoring.

RESULTS:

There was no significant difference in %FEV1 at 3 h between the 2 groups. The dyspnea scores were significantly improved for patients treated with bedoradrine compared to placebo (AUC0-2 hP < 0.005, AUC0-3 hP < 0.05). The safety profile for those treated with bedoradrine was consistent with the known mechanism of action of β-adrenergic agonists, and included both cardiovascular and metabolic effects.

CONCLUSIONS:

Intravenous bedoradrine, in addition to standard therapy, did not significantly increase %FEV1 at 3 h, but it was associated with significantly improved dyspnea scores.

TRIAL REGISTRATION:

Clinicaltrials.gov; study name: MN-221-CL-007, registration number: NCT00838591; www.clinical trials.gov.

01 Aug 2014·Expert opinion on investigational drugsQ2 · MEDICINE

Bedoradrine for treating asthma and chronic obstructive pulmonary disease

Q2 · MEDICINE

Review

Author: Antoniu, Sabina

INTRODUCTION:

In severe asthma attacks or in severe chronic obstructive pulmonary disease (COPD) exacerbations, inhaled short-acting bronchodilators, such as salbutamol (albuterol), terbutaline or ipratropium, often have a limited effectiveness due to significantly impaired ventilation. For these reasons, the use of a systemic bronchodilator medication might be more appropriate as therapeutic options. However, such formulations, especially salbutamol, are usually, and unfortunately, associated with a high risk of cardiovascular events. For this reason, they are only seldom used, especially in the case of paediatric populations.

AREAS COVERED:

This drug evaluation paper reviews the potential therapeutic agent bedoradrine, an ultraselective β2 agonist, which is currently under development for treating exacerbated asthma and COPD. The article includes a review of both in vitro and in vivo studies as well as a review of the pharmacokinetics, efficacy, safety and tolerability.

EXPERT OPINION:

The intravenous use of bedoradrine has demonstrated promising preliminary efficacy in existing clinical trials for exacerbated asthma. However, the efficacy of bedoradrine is still uncertain in exacerbated COPD. Further clinical studies should assess the efficacy and safety of bedoradrine as an add-on therapy to usual standardised approach and exacerbation-related variables should be used as outcome measures.

01 Dec 2012·The Journal of asthma : official journal of the Association for the Care of AsthmaQ4 · MEDICINE

Evaluation of Bedoradrine Sulfate (MN-221), a Novel, Highly Selective Beta₂-Adrenergic Receptor Agonist for the Treatment of Asthma via Intravenous Infusion

Q4 · MEDICINE

Article

Author: Yuichi Iwaki ; Kazuko Matsuda ; Kirk Johnson ; Malath Makhay

BACKGROUND:

The number of hospitalizations or deaths due to asthma, most of which result from acute exacerbations of asthma, has remained the same for the past 20 years. MN-221 (bedoradrine sulfate) is a novel, highly selective beta2- (β2-) adrenergic agonist administered via intravenous (IV) infusion in development for the treatment for acute exacerbation of asthma.

OBJECTIVES:

Trial MN-221-CL-004 assessed the safety profile and preliminary efficacy of MN-221 in escalating doses in patients with stable mild-to-moderate asthma. Study MN-221-CL-005 assessed the safety profile and preliminary efficacy of MN-221 in patients with stable moderate-to-severe asthma when given as a fixed dose over 1- or 2- hr infusion.

METHODS:

Two randomized, placebo-controlled clinical trials (n = 40) were performed to evaluate the pharmacokinetic (PK) and clinical effects of a novel, highly selective β2-agonist, MN-221, via IV infusion. Safety evaluations included vital signs, adverse events (AEs), clinical laboratory parameters, and electrocardiogram results. Efficacy evaluation included measurement of forced expiratory volume in 1 second (FEV) a₁nd PK parameters were additionally monitored. The study was reviewed and approved by the Institutional Review Board at each site.

RESULTS:

Adverse effects were mild or moderate and there were no serious AEs or deaths during the studies. The most frequently reported AEs were tremor, hypokalemia, and headache. There were no consistent dose-dependent effects of MN-221 on any safety parameters, with the exception of heart rate, which was not considered to be clinically significant and did not require any treatment. Moderate hypokalemia occurred once in one subject in the MN-221-CL-004 study and twice in one subject in the MN-221-CL-005 study and were transient and returned to normal range following single oral potassium chloride treatments. PK assessments indicated a linear response in MN-221 plasma concentrations for the doses evaluated. Dose escalation results showed that mean changes in FEV₁ from pre-infusion were significantly greater than placebo and an overall dose response was statistically significant (p < .0001). Post-infusion FEV1 improvements appeared to plateau at the 30 μg/min dose level despite a higher peak plasma concentration at 60 μg/min. Dose-rate escalation results demonstrated greater mean increases in change in FEV₁ compared to the placebo group with the largest increase associated with the higher MN-221 dose rate and peak plasma concentration.

CONCLUSIONS:

The safety profile of MN-221 and evidence of dose- and plasma-concentration-related bronchodilation supports further clinical development and suggests the potential for clinical benefit without increased clinical risk, particularly for patients where inhaled or nebulized therapy is not adequate or possible. Trial registry name and registration number:Name: MN-221-CL-005Number: NCT00679263.

News (Medical) associated with Bedoradrine Sulfate

05 Dec 2024

·www.globenewswire.com

MediciNova Presents Study Update and Interim Analysis of Phase 2/3 Clinical Trial of MN-166 (ibudilast) in ALS (COMBAT-ALS Clinical Trial) at the 35th International Symposium on ALS/MND

LA JOLLA, Calif., Dec. 05, 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 announces the study update and interim analysis results from the Company’s COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) will be presented at the 35th International Symposium on ALS/MND held December 6-8, 2024 in Montreal, Canada. The highlights of the presentation, titled, “COMBAT-ALS Phase 2b/3 Trial of MN-166 (Ibudilast) in ALS: Trial Update and Interim Analysis Results” (Abstract # 302), include: Study Update: As of November 15, 2024, a total of 217 participants have been enrolled and 183 participants were assigned to either MN-166 or placebo group.Pre-defined interim analysis was conducted to evaluate the correlation between the 6-month and 12-month data and assess the 12-month double-blind phase trial design.A subset of patients from the full analysis set who had ALSFRS-R data at 6 months and at least one post-6-month data point. Correlation analysis of the Combined Assessment of Function and Survival (CAFS) scores at 6 and 12 months as well as modified CAFS scores and ALSFRS-R scores were evaluated.Positive correlations were observed between the 6-month and 12-month data for CAFS score (0.71), modified CAFS score (0.70), and ALSFRS-R (0.69). [Note: Values in parentheses are Spearman Rank Correlation coefficients]Positive correlations were also observed for Bulbar score (0.74), Fine motor score (0.71), and Gross motor score (0.67), but not for Respiratory score. [Note: Values in parentheses are Spearman Rank Correlation coefficients]Interim analysis results were reviewed and validated by an external independent Data Safety Monitoring Board (DSMB), which recommended that the trial continue as per the protocol. MediciNova CMO and Director Kazuko Matsuda commented, "The interim analysis showed a positive correlation between the 6-month and 12-month data. We considered a change in the treatment period, decided to continue the trial with the current treatment plan based on the DSMB's recommendation. We believe these results will be valuable in designing studies for rapidly progressing diseases like ALS. As of mid-November 2024, over 200 patients have been enrolled and more than 180 patients assigned, if we continue to actively enroll in the COMBAT-ALS study, we expect to complete patient assignments by June 2025 with trial results expected in 2026. Concurrently, we have been supporting continued treatment for those patients wishing to continue MN-166 treatment after the 6-month open-label phase via the FDA's Expanded Access Program (EAP). Next year, the NIH-funded, large-scale Expanded Access Program trial is set to begin, and we look forward to the opportunity to provide access to MN-166 to more ALS patients.” 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: David H. Crean, Ph.D.Chief Business OfficerMediciNova, Incinfo@medicinova.com

Phase 2Phase 3Clinical Result

19 Nov 2024

·www.globenewswire.com

MediciNova CEO Yuichi Iwaki Provides Corporate Update in Letter to Stockholders

NIH-funded Phase 2-3 ALS Expanded Access study expands reach of MediciNova’s ongoing COMBAT-ALS trial and provides illustration of Company’s development strategyLA JOLLA, Calif., Nov. 19, 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) focused on development of novel anti-inflammatory treatments for neurodegenerative diseases, malignant brain cancers, and metabolic diseases, provides shareholders a corporate update in the following Letter to Stockholders from CEO Yuichi Iwaki, M.D., Ph.D.: To our esteemed stockholders, Since its founding, MediciNova has been clear in its mission to deliver new treatment options to the patients suffering with unmet medical needs. In service of that mission, we have been steadfast in our commitment to both further our science in partnership with some of the greatest minds across the United States, and to do so in a way that preserves capital and provides optimal value to shareholders. Our recently announced collaboration to supply our compound MN166 (ibudilast) as part of an NIH-funded expanded access clinical trial is illustrative of this commitment, as it provides the Company with non-dilutive funding as we collaborate to continue to develop MN166 for ALS without incurring the expenses associated with an additional clinical trial. The six-month trial is being conducted with 17 institutions, all under the aegis of the lead institution and funded entirely by the NIH and without the added expenses of contract research organizations (CROs). Concurrently, we are conducting the COMBAT-ALS trial, our Company-sponsored Phase 2/3 trial of MN166 for ALS, which is a sponsored 12-month trial. We believe that the combination of the two trials allow us to more completely investigate MN166 in a significantly larger patient population, while maintaining a prudent hold on cash. Importantly, the NIH-funded trial is also very much in line with our corporate strategy, which is to choose a small number of trials on which to focus our resources and identify partners and other funding sources to ensure that additional programs are conducted, our pipeline is robust, and yet our cash reserves are minimally impacted. Another current example of this strategy is an ongoing clinical trial of MN-166 in Long COVID, which is being funded and conducted under the aegis of Health Canada. Much like the ALS program, MediciNova is providing study drug and some administrative support. However, the Canadian government is largely responsible for most other aspects of the trial. Once the trial is complete, Health Canada will turn the results over to the Company at which time it will be in a position to then apply for approval under that indication to Health Canada. We anticipate that there may be advantages in the regulatory process in Canada resulting from the partnership. We have several additional programs that are being overseen by both U.S. government agencies (NIH, BARDA) and outside the U.S. that follow this model of partnering with prestigious institutions and government agencies to conduct and sponsor clinical trials. Our responsibilities are usually limited to providing study drug in most of these cases, along with administrative and trial design support. Ultimately, for the sake of clarity, we consider our core programs those for which we have direct fiscal responsibility, such as with our COMBAT-ALS trial, as well as the emerging glioblastoma program. However, our non-core programs, such as the above mentioned Long COVID and others for which we only provide study drug and guidance – but almost never cash – are easy ways for us to create revenue over time, and significant shareholder value. Our cash and cash equivalents position remains strong, with $42.3 million as of September 30, 2024. As discussed, we are extremely careful in the way we use our cash, and we look forward to an additional non-dilutive cash payout as a result of our recently announced award in connection with the Sanofi/Novartis settlement. We will provide additional information on that award in the coming weeks. The global landscape is in a state of perpetual flux, encompassing the natural environment, economy, and technological advancements. In the midst of these dynamic changes, our aspiration is to cultivate a society where every individual can attain lifelong health and enjoy a prosperous and fulfilling life. In pursuit of this vision, we are committed to fostering sustainable growth, and we believe that this approach is essential to manage cash while driving multiple programs through a complicated global development and regulatory landscape. We also understand that our story may be perceived as complex. I hope that laying out this approach has gone some distance to help clarify our story. In the meantime, we also recently announced that our Chief Business Officer, Dr. David Crean, has also assumed the role of managing our communications. We believe it is essential that current and future investors understand the nuances of our company, and have open, two-way communications to ensure clarity and transparency. Transparency is all the more important as we are the only dual-listed biopharmaceutical company, listed both at NASDAQ market and Tokyo Stock Exchange, which presents the challenge of ensuring that all of our shareholders from both markets are up to date, and in the know. We are very excited about the future at MediciNova and anticipate providing status updates regularly beginning in the coming weeks. In the meantime, we remain grateful to those shareholders who have shown their loyalty over the years and look forward to welcoming new shareholders to the fold. Sincerely, Dr. Yuichi Iwaki MediciNova Founder, CEO and President 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, two of which are the Company’s primary focus. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS), and Phase 2 in glioblastoma. 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:David H. Crean, Ph.D.Chief Business OfficerMediciNova, Incinfo@medicinova.com

Phase 2Phase 3

14 Nov 2024

·www.globenewswire.com

MediciNova Receives Notice of Allowance from United States Patent and Trademark Office for New Patent Covering MN-001 for Triglyceride Synthesis in the Liver

LA JOLLA, Calif., Nov. 14, 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), announces that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a pending patent application for MN-001 (Tipelukast) to cover "Method to Decrease Triglyceride Synthesis in a Liver of a Subject." The allowed claims cover a groundbreaking method for decreasing triglyceride synthesis in the liver by administering MN-001 (Tipelukast) or its metabolite or pharmaceutically acceptable salt. This method is particularly beneficial for subjects diagnosed with insulin resistance, pre-diabetes, or diabetes. Once issued, this patent is expected to expire no earlier than May 26, 2042. Key Claims of the Patent Include: Method：Method 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 various formulations; andDosage Flexibility: The compound can be administered in a range of different dosing frequencies. Kazuko Matsuda, M.D., Ph.D., M.P.H., MediciNova’s Chief Medical Officer commented, ” 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 critical step towards the issuance of the patent, which will provide MediciNova with intellectual property protection for this novel method of treatment. This achievement 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 thought to exert its effects through several mechanisms to produce its anti-inflammatory and anti-fibrotic activity in preclinical models, including leukotriene (LT) receptor antagonism, 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 fibrosis development, and MN-001's inhibitory effect on 5-LO and the 5-LO/LT pathway is a novel approach to treat fibrosis. MN-001 has been shown to down-regulate expression of genes that promote fibrosis including LOXL2, Collagen Type 1 and TIMP-1. MN-001 has also been shown to down-regulate expression of genes that promote inflammation including CCR2 and MCP-1. In addition, MN-001 was found to inhibit triglyceride synthesis in hepatocytes by inhibiting arachidonic acid uptake. About NAFLD, Type 2 Diabetes Mellitus (T2DM), and Hypertriglyceridemia NAFLD is considered the hepatic manifestation of metabolic syndrome; studies have reported that 50% of patients with metabolic syndrome also have NAFLD. There is sufficient clinical and epidemiological evidence supporting the assertion 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. 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: David H. Crean, Ph.D.Chief Business OfficerMediciNova, Incinfo@medicinova.com

Phase 2Phase 3

100 Deals associated with Bedoradrine Sulfate

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D06562	-	-	DB05590

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Indication	Highest Phase	Country/Location	Organization	Date
Status Asthmaticus	Phase 2	US	MediciNova, Inc.	01 Jun 2008
Asthma	Phase 2	US	MediciNova, Inc.	01 Feb 2008
Obstetric Labor, Premature	Phase 2	US	MediciNova, Inc.	-
Obstetric Labor, Premature	Phase 2	GB	Kissei Pharmaceutical Co., Ltd.	-
Pulmonary Disease, Chronic Obstructive	Phase 1	US	MediciNova, Inc.	01 Nov 2009

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00838591 (MN-221-CL-007, Pubmed \| Respir Med) Manual	Phase 2	Asthma	167	bedoradrine	uvfnudtkpx(rmcntopdli) = mvvqyohyog bmglzigezw (mngilexhhk, 19.3)	Negative	01 Oct 2015
NCT00838591 (MN-221-CL-007, Pubmed \| Respir Med) Manual	Phase 2	Asthma	167	Placebo	uvfnudtkpx(rmcntopdli) = bsrhmpjakp bmglzigezw (mngilexhhk, 20.1)	Negative	01 Oct 2015
NCT00679263 (CTgov)	Phase 2	Asthma	17	Placebo	hcxdlsujpy(fuizwolaue) = meduypkfkj oixlzopnrp (necwaibydh, zmhslezjnb - dotycptzfa) View more	-	15 Dec 2011

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Bio Sequences Search & Analysis

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Chemical Structures Search & Analysis