MediciNova Provides Enrollment Update for Ongoing ALS and Hypertriglyceridemia Clinical Trials
MediciNova (NASDAQ:MNOV) reported significant progress in two key clinical trials. The Phase 2/3 COMBAT-ALS trial for MN-166 (ibudilast) is now down to single-digit patient enrollment requirements. Additionally, their Phase 2 trial studying MN-001 (tipelukast) for dyslipidemia and fatty liver disease in type 2 diabetes patients needs only two more participants.
The company's ALS program includes a large Expanded Access Program (EAP) supported by a $22 million NIH grant. MediciNova expects to engage in FDA regulatory discussions and anticipates top-line data by the end of 2026.
MediciNova (NASDAQ:MNOV) ha riportato progressi significativi in due studi clinici chiave. La sperimentazione di Fase 2/3 COMBAT-ALS per MN-166 (ibudilast) è ormai vicina al completamento dell'arruolamento, con pochi pazienti ancora necessari. Inoltre, il loro studio di Fase 2 su MN-001 (tipelukast) per dislipidemia e steatosi epatica in pazienti con diabete di tipo 2 necessita solo di due partecipanti in più.
Il programma ALS dell’azienda include un ampio Programma di Accesso Esteso (EAP) sostenuto da una borsa di studio NIH da 22 milioni di dollari. MediciNova prevede di avviare discussioni regolatorie con la FDA e si aspetta di ottenere i dati principali entro la fine del 2026.
MediciNova (NASDAQ:MNOV) ha informado avances significativos en dos ensayos clínicos clave. El ensayo de fase 2/3 COMBAT-ALS para MN-166 (ibudilast) está ahora cerca de completar el reclutamiento, necesitando solo unos pocos pacientes más. Además, su ensayo de fase 2 que estudia MN-001 (tipelukast) para dislipidemia y enfermedad hepática grasa en pacientes con diabetes tipo 2 requiere únicamente dos participantes adicionales.
El programa de ALS de la compañía incluye un amplio Programa de Acceso Expandido (EAP) respaldado por una subvención del NIH de 22 millones de dólares. MediciNova espera iniciar conversaciones regulatorias con la FDA y anticipa datos principales para finales de 2026.
MediciNova (NASDAQ:MNOV)는 두 가지 주요 임상 시험에서 중요한 진전을 보고했습니다. MN-166(이부디라스트)에 대한 2/3상 COMBAT-ALS 시험은 현재 단일 자리수 환자 등록만 남아 있습니다. 또한, 2상 시험인 MN-001(티펠루카스트)는 제2형 당뇨병 환자의 이상지질혈증 및 지방간 질환을 연구하며 단 2명의 참가자만 추가 모집하면 됩니다.
회사의 ALS 프로그램에는 2,200만 달러 NIH 보조금으로 지원되는 대규모 확장 접근 프로그램(EAP)이 포함되어 있습니다. MediciNova는 FDA 규제 논의를 진행할 예정이며 2026년 말까지 주요 데이터 발표를 기대하고 있습니다.
MediciNova (NASDAQ:MNOV) a annoncé des progrès significatifs dans deux essais cliniques majeurs. L'essai de phase 2/3 COMBAT-ALS pour MN-166 (ibudilast) est désormais proche d'atteindre l'objectif d'inclusion, avec seulement quelques patients restants à recruter. De plus, leur essai de phase 2 portant sur MN-001 (tipelukast) pour la dyslipidémie et la stéatose hépatique chez les patients diabétiques de type 2 nécessite seulement deux participants supplémentaires.
Le programme ALS de la société comprend un vaste Programme d'Accès Élargi (EAP) soutenu par une subvention NIH de 22 millions de dollars. MediciNova prévoit d'entamer des discussions réglementaires avec la FDA et anticipe des données principales d'ici la fin 2026.
MediciNova (NASDAQ:MNOV) meldete bedeutende Fortschritte in zwei wichtigen klinischen Studien. Die Phase-2/3-Studie COMBAT-ALS für MN-166 (Ibudilast) steht kurz vor dem Abschluss der Patientenrekrutierung mit nur noch einstelliger Anzahl an benötigten Teilnehmern. Zudem benötigt ihre Phase-2-Studie zu MN-001 (Tipelukast) bei Dyslipidämie und Fettlebererkrankung bei Typ-2-Diabetikern nur noch zwei weitere Teilnehmer.
Das ALS-Programm des Unternehmens umfasst ein großes Expanded Access Program (EAP), das durch einen 22-Millionen-Dollar NIH-Zuschuss unterstützt wird. MediciNova plant regulatorische Gespräche mit der FDA und erwartet die wichtigsten Studiendaten bis Ende 2026.
- None.
- Both clinical trials still require additional patient enrollment for completion
Insights
MediciNova nears completion of patient enrollment in two key clinical trials, showing meaningful development progress toward potential data readouts.
MediciNova's announcement represents a significant clinical development milestone as the company approaches full enrollment in two important trials. For the Phase 2/3 COMBAT-ALS trial of MN-166 (ibudilast), they now need only single-digit patient enrollment to complete randomization. This progress follows their interim results released last year and runs parallel to their NIH-funded
For context, completing enrollment is a critical inflection point in clinical development that signals the company is on track toward data readouts. The COMBAT-ALS trial is particularly noteworthy given the devastating nature of ALS and the significant unmet need for effective treatments. The company anticipates top-line data by the end of 2026 and is preparing for regulatory discussions with the FDA.
Similarly, their MN-001 (tipelukast) Phase 2 trial in patients with dyslipidemia and fatty liver disease due to type 2 diabetes needs just two more patients to complete randomization. This indicates the company is executing efficiently across multiple clinical programs simultaneously.
While this update doesn't provide new efficacy or safety data, it demonstrates operational execution and suggests both programs remain on track. The announcement confirms MediciNova's development timeline is proceeding as planned, with important data readouts on the horizon that could potentially validate their therapeutic approach in these challenging disease areas with substantial unmet needs.
MN-166 COMBAT ALS trial down to single digit required enrollment while MN-001 hypertriglyceridemia trial in type 2 diabetes patients requires final two patients
LA JOLLA, Calif., July 24, 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) (the “Company”), today provides an update on the enrollment of two key ongoing clinical trials for the Company’s developmental compounds MN-166 (ibudilast) and MN-001 (tipelukast), each of which is poised to complete randomization.
Specifically, the Company is now down to single digit required randomization in its ongoing Phase 2/3 COMBAT-ALS trial. Concurrently, the Company is seeking the final two randomized subjects for its Phase 2 trial in patients with dyslipidemia and fatty liver disease due to type 2 diabetes.
Dr. Yuichi Iwaki, MediciNova President and CEO, commented, "We are pleased to report continued strong progress in our core COMBAT-ALS program. Following the release of interim results last year, we are now approaching the completion of patient randomization—a key milestone in the study. Our MN-166 ALS program continues to generate significant interest and anticipation within the ALS community. In parallel, the large Expanded Access Program (EAP), supported by a
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 was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS). MediciNova holds Orphan Drug Designation for MN-166 in ALS by U.S. FDA and EU EMA. MN-166 has received Fast Track Designation by FDA for treatment of ALS. In addition, MN-166 holds Orphan Disease Designation for the treatment of Glioblastoma.
About MN-001 (tipelukast)
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 MediciNova
MediciNova, Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of serious diseases with unmet medical needs and a commercial focus on the United States (U.S.) market. The company’s current strategy is to focus their development activities on MN-166 (ibudilast) for neurological and other disorders such as amyotrophic lateral sclerosis (ALS), progressive multiple sclerosis (MS), chemotherapy-induced peripheral neuropathy, degenerative cervical myelopathy, glioblastoma, substance dependence and addiction (e.g., methamphetamine dependence, opioid dependence, and alcohol dependence), prevention of acute respiratory distress syndrome (ARDS), and Long COVID, and MN-001 (tipelukast) for fibrotic and other metabolic disorders such as nonalcoholic fatty liver disease (NAFLD) and hypertriglyceridemia. The company intends to advance their pipeline through a combination of investigator-sponsored clinical trials, trials funded through government grants or other grants, trials funded on their own, or through strategic alliances to help support further clinical development of their lead programs.
Forward-Looking Statements
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
FAQ
What is the current status of MediciNova's (MNOV) COMBAT-ALS trial?
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When will MediciNova (MNOV) release top-line data for its ALS trial?
How many patients are still needed for MediciNova's type 2 diabetes trial?
What conditions is MediciNova's MN-001 (tipelukast) targeting?
