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.

开始日期2012-03-01

申办/合作机构

MediciNova, Inc.

NCT01013142 / Completed临床1期

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.

开始日期2009-11-01

申办/合作机构

MediciNova, Inc.

NCT00838591 / Completed临床2期

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.

开始日期2009-03-01

申办/合作机构

MediciNova, Inc.

100 项与 Bedoradrine Sulfate 相关的临床结果

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100 项与 Bedoradrine Sulfate 相关的转化医学

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100 项与 Bedoradrine Sulfate 相关的专利（医药）

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项与 Bedoradrine Sulfate 相关的文献（医药）

2015-10-01·Respiratory medicine3区 · 医学

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

3区 · 医学

Article

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

2014-08-01·Expert opinion on investigational drugs2区 · 医学

Bedoradrine for treating asthma and chronic obstructive pulmonary disease

2区 · 医学

Review

作者: 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.

2012-12-01·The Journal of asthma : official journal of the Association for the Care of Asthma4区 · 医学

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

4区 · 医学

Article

作者: 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.

项与 Bedoradrine Sulfate 相关的新闻（医药）

2024-11-11

·GlobeNewswire-Health Care

MediciNova Given Notice of Monetary Damages Due Under Patent Settlement of Sanofi-Novartis

LA JOLLA, Calif., Nov. 11, 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 it was notified by Sanofi that the Sanofi/Novartis litigation was settled. Accordingly, MediciNova is entitled to receive a certain amount of monetary damages through this settlement. Further details will be provided as they become available. Yuichi Iwaki, M.D., Ph.D., MediciNova CEO commented, “The successful resolution of the Sanofi-Novartis litigation and the resulting monetary damages due to MediciNova both validates the value of our intellectual property and provides an additional source of non-dilutive funding, which we plan to apply to supporting our ongoing clinical development programs, particularly our late-stage pipeline targeting inflammatory, metabolic, and neurodegenerative diseases. This outcome further reinforces our commitment to developing unique assets with long-term value. We remain dedicated to preserving our financial position as we continue to prudently advance our novel small molecule therapies towards commercialization." About Sanofi/Novartis litigation On March 30,2022, MediciNova, Inc. was notified that Genzyme Corporation, a subsidiary of Sanofi, filed its First Amended Complaint, which included a claim for infringement of U.S. Patent No. 9,051,542, on February 23, 2022 in a lawsuit previously filed against Novartis Gene Therapies, Inc., Novartis Pharmaceutical Corporation, and Novartis AG in the U.S. District Court for the District of Delaware. This patent, among others was included in the assignment Agreement dated December 19, 2005, between MediciNova, Inc., as successor in interest to Avigen, Inc. and Genzyme Corporation. The plaintiffs allege that the defendants infringe certain U.S. patents through the unauthorized manufacture, use, and sale of recombinant adeno-associated virus vectors (“rAAV vectors”) for their gene therapy drug Zolgensma. If Genzyme recovers any monetary damages, by way of settlement or otherwise, as a result of this litigation, then MediciNova is entitled to receive a certain portion of such monetary damages from Genzyme as per the terms of assignment agreement. About Zolgensma The U.S. Food and Drug Administration (FDA) approved Zolgensma (onasemnogene abeparvovec-xioi) on May 24, 2019. Zolgensma is a gene therapy that treats children under two years old with spinal muscular atrophy (SMA). It was the first gene therapy approved by the FDA to treat a disease. Novartis priced an infusion at $2.1 million, making it one of the priciest medicines on the market. Zolgensma has become one of Novartis’ top-sellers, generating more than $1.3 billion in annual sales in 2023. The company expects it to eventually earn between $1.5 billion and $2 billion annually. Approved in 45 countries, Zolgensma replaces the faulty gene responsible for causing spinal muscular atrophy, a condition that in its severe form robs infants of the ability to stand, sit and, eventually, breathe. Untreated, it’s typically fatal by a very young age. Zolgensma can deliver dramatic benefits, keeping children alive and in some cases helping them achieve motor and developmental milestones they otherwise wouldn’t. In the U.S, its use is limited to babies under the age of two, where it’s seen as having the greatest benefit. 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

临床2期上市批准临床3期

2024-10-23

·GlobeNewswire-Health Care

MediciNova Announces Update of Phase 2/3 Clinical Trial of MN-166 (ibudilast) in ALS patients (COMBAT-ALS) at the 2024 Annual NEALS Meeting (Northeast Amyotrophic Lateral Sclerosis Consortium)

LA JOLLA, Calif., Oct. 23, 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 the lead Principal Investigator of this clinical trial, Björn Oskarsson, MD, FAAN presented the update of an ongoing Phase 2/3 clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) patients at the 2024 Annual NEALS Meeting being held virtually on Oct 21-24, 2024. The presentation entitled “COMBAT-ALS Phase 2b/3 Trial of MN-166 (Ibudilast) in ALS: Study Design and Trial Update” was given by Dr. Oskarsson during the poster session. Dr. Oskarsson discussed the background of MN-166 (ibudilast), scientific rationale, study objectives, study design, major inclusion criteria and enrollment update as of October 18, 2024. Additionally, he discussed the new NIH funding Expand Access Protocol clinical trial*1 in ALS patients. *1:https://investors.medicinova.com/news-releases/news-release-details/medicinova-support-nih-funded-expanded-access-clinical-trial 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

临床2期临床3期临床结果

2024-09-30

·GlobeNewswire-Health Care

MediciNova to Support NIH-Funded Expanded Access Clinical Trial to Evaluate MN166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS)

Academic group to receive a total of $22 million for the trialLA JOLLA, Calif., Sept. 30, 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 the National Institutes of Health (NIH) - Neurological Disorders and Stroke (NINDS) has awarded $22 million for an intermediate size Expanded Access Protocol (EAP) to evaluate the efficacy of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS)1,2. In collaboration with an academic group, MediciNova will provide investigational drug MN-166 (ibudilast), regulatory support, and safety monitoring support. The NIH grant is supported by the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS) signed into law by President Biden. Expanded Access, also referred to as Compassionate Use, is an FDA-regulated pathway that allows individuals with a serious and life-threatening disease to access an investigational drug that is not yet approved by the FDA. This EAP trial will allow individuals with ALS who are not eligible to participate in the COMBAT-ALS trial to receive treatment with MN-166. The EAP will evaluate neurofilament light, a biomarker for neuron damage, and clinical data in two hundred (200) ALS patients treated with MN-166. Dr. Yuichi Iwaki, MediciNova’s President and CEO commented, “The NIH/NINDS grant, and the academic collaboration are significant steps forward in the endeavor to find a solution to this devastating disease. We are honored to support this EAP trial, which will provide MN-166 (ibudilast) to more individuals in advanced stages of ALS who are not eligible to current Phase 2/3 COMBAT-ALS trial. We extend our sincere gratitude to the NIH and NINDS for their support through the Act for ALS. Additionally, we deeply appreciate the participants and their families, as well as the healthcare providers and staff at the site, whose efforts will make this EAP possible, thereby advancing our understanding of MN-166 (ibudilast) as a potential therapy for ALS." About MN-166 (ibudilast) MN-166 (ibudilast) is an orally available 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). MediciNova holds Orphan Drug Designation for MN-166 (ibudilast) in ALS by U.S. FDA and EU EMA. MN-166 (ibudilast) has received Fast Track Designation by FDA for treatment of ALS. In addition, MN-166 (ibudilast) holds Orphan Disease Designation for the treatment of Glioblastoma. About MediciNovaMediciNova, 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 1 https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-awarded-federal-grant-to-study-experimental-als-drug/2 https://www-ninds-nih-gov.libproxy1.nus.edu.sg/news-events/directors-messages/all-directors-messages/updates-act-als

临床2期快速通道孤儿药

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外链

KEGG	Wiki	ATC	Drug Bank
D06562	-	-	DB05590

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
哮喘持续状态	临床2期	美国	MediciNova, Inc.	2008-06-01
哮喘	临床2期	美国	MediciNova, Inc.	2008-02-01
早产	临床2期	美国	MediciNova, Inc.	-
早产	临床2期	英国	Kissei Pharmaceutical Co., Ltd.	-
慢性阻塞性肺疾病	临床1期	美国	MediciNova, Inc.	2009-11-01

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00838591 (MN-221-CL-007, Pubmed \| Respir Med) 人工标引	临床2期	哮喘	167	bedoradrine	製鏇獵鏇糧艱鏇膚製襯(鹹獵簾鹽製壓艱顧廠襯) = 齋構鏇壓鏇餘築醖憲糧築憲鬱衊製淵壓鹹廠糧 (鹽構選範鏇遞壓觸簾築, 19.3)	不佳	2015-10-01
NCT00838591 (MN-221-CL-007, Pubmed \| Respir Med) 人工标引	临床2期	哮喘	167	Placebo	製鏇獵鏇糧艱鏇膚製襯(鹹獵簾鹽製壓艱顧廠襯) = 鹹廠憲鬱壓衊構遞繭鹽築憲鬱衊製淵壓鹹廠糧 (鹽構選範鏇遞壓觸簾築, 20.1)	不佳	2015-10-01
NCT00679263 (CTgov)	临床2期	哮喘	17	Placebo	鑰糧壓醖壓選鑰壓餘積(壓願積襯鹹淵積壓膚憲) = 鑰廠壓鏇膚餘遞醖遞鑰遞網觸構襯淵夢鹹製製 (壓鏇壓齋鹽顧鏇製鏇製, 醖製壓餘廠獵膚淵構網 ~ 鹹製齋築獵鬱衊選鹹顧) 更多	-	2011-12-15