MediciNova Announces Completion of Patient Enrollment in MN-001-NATG-202 Clinical Trial of MN-001 (Tipelukast)
MediciNova (NASDAQ:MNOV) announced completion of patient enrollment in the Phase 2 MN-001-NATG-202 trial of MN-001 (tipelukast) for hypertriglyceridemia and NAFLD due to Type 2 diabetes.
The multi-center, randomized, double-blind, placebo-controlled study randomizes patients 1:1 to 500 mg/day MN-001 or placebo for 24 weeks. Co-primary endpoints are change in liver fat by CAP score and change in fasting serum triglycerides at Week 24. Secondary endpoints include safety, tolerability, and changes in HDL-C, LDL-C, and total cholesterol. Patient recruitment is closed and top-line data are expected by summer 2026.
MediciNova (NASDAQ:MNOV) ha annunciato il completamento dell'arruolamento dei pazienti nello studio di fase 2 MN-001-NATG-202 su MN-001 (tipelukast) per l'ipertrigliceridemia e NAFLD dovuti al diabete di tipo 2.
Lo studio multicentrico, randomizzato, in doppio cieco e controllato con placebo assegna ai pazienti in rapporto 1:1 MN-001 500 mg/giorno oppure placebo per 24 settimane. Gli endpoint co-primari sono la variazione del contenuto di grasso nel fegato misurata con il punteggio CAP e la variazione dei trigliceridi a digiuno nel siero al 24º settimana. Gli endpoint secondari includono sicurezza, tollerabilità e variazioni di HDL-C, LDL-C e colesterolo totale. L'arruolamento dei pazienti è chiuso e i dati principali sono previsti dall'estate 2026.
MediciNova (NASDAQ:MNOV) anunció la finalización de la inscripción de pacientes en el ensayo de fase 2 MN-001-NATG-202 de MN-001 (tipelukast) para hipertrigliceridemia y NAFLD debido a la diabetes tipo 2.
El estudio multicéntrico, aleatorizado, doble ciego, y controlado con placebo asigna a los pacientes en una relación 1:1 a MN-001 500 mg/día o placebo durante 24 semanas. Los objetivos co-prioritarios son el cambio en la grasa hepática medido por la puntuación CAP y el cambio en los triglicéridos en suero en ayunas en la semana 24. Los objetivos secundarios incluyen seguridad, tolerabilidad y cambios en HDL-C, LDL-C y colesterol total. El reclutamiento de pacientes está cerrado y se esperan los datos principales para el verano de 2026.
MediciNova (NASDAQ:MNOV)는 MN-001(NT-코드: tipelukast)에 대한 2상 MN-001-NATG-202 시험의 환자 모집 완료를 발표했습니다. 이 시험은 고중성지방혈증과 제2형 당뇨병으로 인한 비알코올성 지방간질환(NAFLD)을 대상으로 합니다.
다기관 무작위 이중맹검 위약대조 연구는 환자들을 500 mg/일 MN-001 또는 위약으로 24주간 1:1 비율로 배정합니다. 공동 1차 종속변수는 CAP 점수로 측정한 간 지방의 변화와 24주 차 공복 혈청 중성지방의 변화입니다. 보조 종속변수에는 안전성 및 내약성, HDL-C, LDL-C, 총콜레스테롤의 변화가 포함됩니다. 환자 모집은 종료되었으며 상위 데이터를 2026년 여름까지 기대하고 있습니다.
MediciNova (NASDAQ:MNOV) a annoncé l'achèvement du recrutement des patients dans l'essai de phase 2 MN-001-NATG-202 évaluant MN-001 (tipelukast) pour l'hypertriglycéridémie et la NAFLD liée au diabète de type 2.
L'étude multicentrique, randomisée, en double aveugle et contrôlée par placebo attribue les patients, en ratio 1:1, à 500 mg/jour de MN-001 ou au placebo pendant 24 semaines. Les critères coprimaires sont le changement de teneur en graisse hépatique mesuré par le score CAP et le changement des triglycérides sériques à jeun à la semaine 24. Les critères secondaires incluent la sécurité, la tolérance et les variations de HDL-C, LDL-C et du cholestérol total. Le recrutement est clos et les données de référence sont prévues pour l'été 2026.
MediciNova (NASDAQ:MNOV) gab die Beendigung der Patienteneinschreibung in der Phase-2-Studie MN-001-NATG-202 von MN-001 (Tipelukast) für Hypertriglyceridämie und NAFLD aufgrund von Typ-2-Diabetes bekannt.
Die multizentrische, randomisierte, doppelblinde, placebokontrollierte Studie randomisiert die Patienten im Verhältnis 1:1 zu 500 mg/Tag MN-001 oder Placebo über 24 Wochen. Zu den primären Endpunkten gehören die Veränderung des Leberfetts gemessen am CAP-Score und die Veränderung der nüchternen Triglyceride im Serum in Woche 24. Zu den Sekundärendpunkten zählen Sicherheit, Verträglichkeit sowie Veränderungen von HDL-C, LDL-C und Cholesterin Gesamt. Die Rekrutierung der Patienten ist abgeschlossen und die ersten Ergebnisse werden bis Sommer 2026 erwartet.
شركة MediciNova (NASDAQ:MNOV) أعلنت اكتمال تسجيل المرضى في تجربة المرحلة 2 MN-001-NATG-202 للعلاج MN-001 (تيبيلوزاكست) لعسر شحميات الدم العالية والتهاب الكبد الدهني غير الكحولي NAFLD الناتج عن داء السكري من النوع 2.
تُقسِّم الدراسة متعددة المراكز العشوائية المزدوجة التعمية، المعتمدة على دواء وهمي، المرضى بنسبة 1:1 إلى 500 mg/يوم MN-001 أو دواء وهمي لمدة 24 أسبوعاً. نقاط النهاية المشتركة الأولية هي التغير في دهون الكبد المقاسة باستخدام درجة CAP والتغير في ثلاثي الغليسريد في مصل الدم أثناء الصيام عند الأسبوع 24. تشمل النقاط الثانوية السلامة، التحمل، والتغيرات في HDL-C، LDL-C والكوليسترول الكلي. recruitment انتهى، ونتوقع الحصول على البيانات الأساسية بحلول صيف 2026.
- Patient enrollment in Phase 2 trial completed
- Randomized, double-blind, placebo-controlled design
- Dosing defined as 500 mg/day for 24 weeks
- Co-primary endpoints target liver fat and triglycerides
- Top-line data expected by summer 2026
- No efficacy or safety results available yet
- Top-line readout not expected until summer 2026
LA JOLLA, Calif., Nov. 04, 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 announces the completion of patient enrollment in its Phase 2 clinical trial, MN-001-NATG-202, evaluating MN-001 (Tipelukast) for the treatment of hypertriglyceridemia and non-alcoholic fatty liver disease (NAFLD) due to Type 2 diabetes (T2DM). Patient recruitment is closed.
The MN-001-NATG-202 study is a multi-center, randomized, double-blind, placebo-controlled trial to evaluate MN-001(tipelukast). Patients are randomized 1:1 to receive either 500 mg/day of MN-001 (tipelukast) or placebo for 24 weeks. The co-primary endpoints are (1) change from baseline in liver fat content measured by controlled attenuation parameter (CAP) score at Week 24, and (2) change from baseline in fasting serum triglycerides at Week 24. Secondary endpoints include safe24 and tolerability and changes in lipid profile (HDL-C, LDL-C, and total cholesterol). Top-line data are expected by the summer of 2026
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 phosphodiesterase (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. It also inhibits triglyceride synthesis in hepatocytes by inhibiting arachidonic acid uptake. Recent research suggested that MN-002, the major metabolite of MN-001, significantly enhanced cholesterol efflux in macrophages by upregulating key transport proteins ABCA1 and ABCG1.
About Type 2 Diabetes Mellitus (T2DM), Dyslipidemia and non-alcoholic fatty liver disease (NAFLD)
Type 2 diabetes mellitus (T2DM) is a metabolic disorder characterized by insulin resistance, which plays a central role in the development of dyslipidemia—abnormal levels of lipids in the blood. Hypertriglyceridemia (elevated triglycerides) is commonly observed in individuals with T2DM. It results from increased hepatic lipid synthesis and impaired clearance of triglyceride-rich lipoproteins. Hypercholesterolemia, particularly elevated LDL cholesterol and reduced HDL cholesterol, is also frequently seen and contributes to a higher risk of atherosclerosis. Dyslipidemia not only worsens glycemic control but also increases the risk of cardiovascular complications and liver-related conditions such as nonalcoholic fatty liver disease (NAFLD). NAFLD is considered a hepatic complication of insulin resistance and is frequently associated with T2DM and dyslipidemia.
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.
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 did MediciNova (MNOV) announce on November 4, 2025 about MN-001?
What is the MN-001-NATG-202 trial design for MNOV (MN-001)?
What are the co-primary endpoints in the MNOV Phase 2 MN-001 trial?
When will MediciNova (MNOV) report top-line data from the MN-001 Phase 2 trial?
Does the MN-001 Phase 2 announcement include any efficacy or safety results for MNOV?
What secondary endpoints will MediciNova (MNOV) assess in MN-001-NATG-202?
