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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)

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MediciNova (NASDAQ:MNOV) provided an update on its ongoing Phase 2/3 clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) patients at the 2024 Annual NEALS Meeting. Lead Principal Investigator Dr. Björn Oskarsson presented details about the COMBAT-ALS trial, including the study design, objectives, and major inclusion criteria. The presentation also covered enrollment updates as of October 18, 2024, and discussed a new NIH-funded Expanded Access Protocol clinical trial in ALS patients.

MediciNova (NASDAQ:MNOV) ha fornito un aggiornamento sulla sua sperimentazione clinica in corso di fase 2/3 su MN-166 (ibudilast) nei pazienti affetti da Sclerosi Laterale Amiotrofica (SLA) durante il Meeting Annuale NEALS 2024. Il principale investigatore, il Dr. Björn Oskarsson, ha presentato dettagli sulla sperimentazione COMBAT-ALS, inclusi il design dello studio, gli obiettivi e i principali criteri di inclusione. La presentazione ha anche trattato gli aggiornamenti sull'arruolamento fino al 18 ottobre 2024 e ha discusso di un nuovo studio clinico finanziato dal NIH, riguardante un protocollo di accesso espanso per i pazienti con SLA.

MediciNova (NASDAQ:MNOV) proporcionó una actualización sobre su ensayo clínico en curso de fase 2/3 de MN-166 (ibudilast) en pacientes con Sclerosis Lateral Amiotrófica (ELA) durante la Reunión Anual NEALS 2024. El investigador principal, Dr. Björn Oskarsson, presentó detalles sobre el ensayo COMBAT-ALS, incluidos el diseño del estudio, los objetivos y los principales criterios de inclusión. La presentación también abarcó actualizaciones de inscripción hasta el 18 de octubre de 2024 y discutió un nuevo ensayo clínico financiado por los NIH sobre un protocolo de acceso ampliado en pacientes con ELA.

MediciNova (NASDAQ:MNOV)는 2024 NEALS 연례 회의에서 근위축성 측삭경화증 (ALS) 환자에 대한 MN-166 (ibudilast)의 진행 중인 2/3상 임상 시험에 대한 업데이트를 제공했습니다. 주 연구자 Björn Oskarsson 박사는 COMBAT-ALS 시험에 대한 세부정보를 발표하였으며, 여기에는 연구 설계, 목표 및 주요 포함 기준이 포함되었습니다. 발표에서는 2024년 10월 18일 기준의 등록 업데이트도 다루었으며 ALS 환자를 위한 NIH 자금 지원 확대 접근 프로토콜 임상 시험에 대해서도 논의했습니다.

MediciNova (NASDAQ:MNOV) a fourni une mise à jour sur son essai clinique en cours de phase 2/3 sur MN-166 (ibudilast) chez les patients atteints de Sclérose Latérale Amyotrophique (SLA) lors de la Réunion Annuelle NEALS 2024. Le chercheur principal, Dr. Björn Oskarsson, a présenté des détails sur l'essai COMBAT-ALS, y compris le design de l'étude, les objectifs et les principaux critères d'inclusion. La présentation a également couvert des mises à jour sur le recrutement au 18 octobre 2024 et a discuté d'un nouvel essai clinique financé par les NIH concernant un protocole d'accès élargi pour les patients atteints de SLA.

MediciNova (NASDAQ:MNOV) hat auf dem 2024 NEALS Meeting ein Update zu seiner laufenden Phase 2/3-Studie zu MN-166 (ibudilast) bei amyotropher Lateralsklerose (ALS)-Patienten gegeben. Der leitende Hauptprüfer Dr. Björn Oskarsson präsentierte Einzelheiten zur COMBAT-ALS-Studie, einschließlich des Studiendesigns, der Ziele und der wichtigsten Einschlusskriterien. Die Präsentation beinhaltete auch Anmeldungsupdates zum 18. Oktober 2024 und diskutierte ein neues, von den NIH finanziertes klinisches Studienprotokoll für einen erweiterten Zugang bei ALS-Patienten.

Positive
  • NIH funding secured for Expanded Access Protocol clinical trial
Negative
  • None.

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 Officer
MediciNova, Inc
info@medicinova.com


FAQ

What is the current phase of MediciNova's (MNOV) ALS drug trial?

MediciNova is conducting a Phase 2/3 clinical trial called COMBAT-ALS to evaluate MN-166 (ibudilast) in ALS patients.

What was presented at the 2024 NEALS Meeting regarding MNOV's ALS trial?

Dr. Björn Oskarsson presented updates on the COMBAT-ALS trial, including study design, objectives, inclusion criteria, and enrollment status as of October 18, 2024.

Has MNOV received NIH funding for its ALS research?

Yes, MediciNova has received NIH funding for an Expanded Access Protocol clinical trial in ALS patients.

Medicinova, Inc.

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