First Patient Enrolled in NIH-Funded Expanded Access Program (EAP) Trial to Evaluate MN-166 in Amyotrophic Lateral Sclerosis (ALS) Patients
MediciNova (NASDAQ:MNOV) has announced the enrollment of the first patient in an NIH-funded Expanded Access Program (EAP) trial evaluating MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) patients. The trial aims to provide access to MN-166 for ALS patients who are not eligible for the ongoing Phase 2/3 COMBAT-ALS trial.
The EAP trial, funded by the National Institutes of Health (NIH) - Neurological Disorders and Stroke (NINDS), will assess the safety and efficacy of MN-166 in approximately 200 ALS patients. This initiative specifically targets individuals in advanced stages of ALS who cannot participate in the current Phase 2/3 COMBAT-ALS trial.
MediciNova (NASDAQ:MNOV) ha annunciato l'arruolamento del primo paziente in uno studio del Programma di Accesso Espanso (EAP) finanziato dal NIH, che valuta MN-166 (ibudilast) nei pazienti affetti da Sclerosi Laterale Amiotrofica (SLA). Lo studio mira a fornire accesso a MN-166 per i pazienti SLA che non sono idonei per il trial in corso di Fase 2/3 COMBAT-ALS.
Lo studio EAP, finanziato dal National Institutes of Health (NIH) - Neurological Disorders and Stroke (NINDS), valuterà la sicurezza e l'efficacia di MN-166 in circa 200 pazienti SLA. Questa iniziativa si rivolge specificamente a individui in stadi avanzati di SLA che non possono partecipare al trial attuale di Fase 2/3 COMBAT-ALS.
MediciNova (NASDAQ:MNOV) ha anunciado la inclusión del primer paciente en un ensayo del Programa de Acceso Expandido (EAP) financiado por los NIH, que evalúa MN-166 (ibudilast) en pacientes con
El ensayo EAP, financiado por los National Institutes of Health (NIH) - Neurological Disorders and Stroke (NINDS), evaluará la seguridad y eficacia de MN-166 en aproximadamente 200 pacientes de ELA. Esta iniciativa se dirige específicamente a individuos en etapas avanzadas de ELA que no pueden participar en el ensayo actual de Fase 2/3 COMBAT-ALS.
MediciNova (NASDAQ:MNOV)는 NIH가 자금을 지원하는 확대 접근 프로그램(EAP) 시험에 첫 번째 환자가 등록되었음을 발표했습니다. 이 시험은 MN-166 (이부디라스트)를 근위축성 측삭 경화증 (ALS) 환자에서 평가합니다. 이 시험의 목적은 진행 중인 2/3상 COMBAT-ALS 시험에 참여할 수 없는 ALS 환자에게 MN-166에 대한 접근을 제공하는 것입니다.
EAP 시험은 National Institutes of Health (NIH) - Neurological Disorders and Stroke (NINDS)의 자금을 받아 진행되며, 약 200명의 ALS 환자에서 MN-166의 안전성과 효능을 평가할 것입니다. 이 이니셔티브는 현재 2/3상 COMBAT-ALS 시험에 참여할 수 없는 ALS의 진행된 단계에 있는 개인을 특별히 대상으로 합니다.
MediciNova (NASDAQ:MNOV) a annoncé l'inscription du premier patient dans un essai du Programme d'Accès Élargi (EAP) financé par les NIH, évaluant MN-166 (ibudilast) chez des patients atteints de Sclérose Latérale Amyotrophique (SLA). L'essai vise à fournir un accès à MN-166 pour les patients SLA qui ne sont pas éligibles pour l'essai en cours de Phase 2/3 COMBAT-ALS.
L'essai EAP, financé par les National Institutes of Health (NIH) - Neurological Disorders and Stroke (NINDS), évaluera la sécurité et l'efficacité de MN-166 chez environ 200 patients SLA. Cette initiative cible spécifiquement les individus à des stades avancés de la SLA qui ne peuvent pas participer à l'essai actuel de Phase 2/3 COMBAT-ALS.
MediciNova (NASDAQ:MNOV) hat die Einschreibung des ersten Patienten in eine von den NIH finanzierte Studie des Expanded Access Program (EAP) bekannt gegeben, die MN-166 (Ibudilast) bei Patienten mit Amyotropher Lateralsklerose (ALS) bewertet. Die Studie zielt darauf ab, ALS-Patienten, die nicht für die laufende Phase 2/3 COMBAT-ALS-Studie geeignet sind, Zugang zu MN-166 zu gewähren.
Die EAP-Studie, die vom National Institutes of Health (NIH) - Neurological Disorders and Stroke (NINDS) finanziert wird, wird die Sicherheit und Wirksamkeit von MN-166 bei etwa 200 ALS-Patienten bewerten. Diese Initiative richtet sich speziell an Personen in fortgeschrittenen Stadien von ALS, die nicht an der aktuellen Phase 2/3 COMBAT-ALS-Studie teilnehmen können.
- NIH funding secured for the EAP trial, reducing company expenses
- Expansion of MN-166 testing to 200 additional ALS patients
- Progress in clinical development with first patient enrolled
- None.
LA JOLLA, Calif., April 08, 2025 (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 enrollment of the first patient in the NIH-funded Expanded Access Program (EAP) trial to evaluate MN-166 (ibudilast) in patients with Amyotrophic Lateral Sclerosis (ALS).
This significant milestone marks the beginning of a critical trial aimed at providing access to MN-166 for ALS patients who are not eligible for the ongoing Phase 2/3 COMBAT-ALS trial. The EAP trial, funded by the National Institutes of Health (NIH) - Neurological Disorders and Stroke (NINDS)1-3, will evaluate the safety and efficacy of MN-166 in approximately 200 ALS patients.
Dr. Yuichi Iwaki, President and CEO of MediciNova, commented: "We are honored to support this EAP trial, which will provide MN-166 to more individuals in advanced stages of ALS who are not eligible to our 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 sites, whose efforts will make this EAP possible."
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.
1https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-awarded-federal-grant-to-study-experimental-als-drug/
2https://www.ninds.nih.gov/news-events/directors-messages/all-directors-messages/updates-act-als
3https://investors.medicinova.com/news-releases/news-release-details/medicinova-support-nih-funded-expanded-access-clinical-trial
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 and MN-001. 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 and MN-001, 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, 2024 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
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