Monopar to Present New Long-Term Neurological Efficacy and Safety Data for ALXN1840 in Wilson Disease at the 150th American Neurological Association Annual Meeting
Monopar Therapeutics (Nasdaq: MNPR) will present new long-term data for its investigational therapy ALXN1840 in Wilson disease at the 150th American Neurological Association Annual Meeting. The analysis combines data from four clinical trials with 266 patients and a median treatment duration of 2.6 years.
Key findings include statistically significant neurologic improvements sustained over 6 years, measured by UWDRS Parts II and III. Patients who switched from standard of care to ALXN1840 showed additional neurological improvement. The drug demonstrated a favorable safety profile with less than 1% of patients experiencing drug-related neurological serious adverse events across more than 645 patient-years.
Monopar Therapeutics (Nasdaq: MNPR) presenterà nuovi dati a lungo termine sul proprio trattamento sperimentale ALXN1840 per la malattia di Wilson all'incontro annuale 150° dell'American Neurological Association. L'analisi combina dati di quattro studi clinici con 266 pazienti e una durata media del trattamento di 2,6 anni.
I risultati chiave includono miglioramenti neurologici statisticamente significativi mantenuti per 6 anni, misurati con UWDRS Part II e III. I pazienti che sono passati dalla terapia standard ad ALXN1840 hanno mostrato ulteriori miglioramenti neurologici. Il farmaco ha mostrato un profilo di sicurezza favorevole con meno dell'1% dei pazienti che hanno riportato eventi avversi neurologici gravi correlati al farmaco in oltre 645 anni-paziente.
Monopar Therapeutics (Nasdaq: MNPR) presentará nuevos datos a largo plazo sobre su terapia experimental ALXN1840 para la enfermedad de Wilson en la 150.ª Reunión Anual de la American Neurological Association. El análisis combina datos de cuatro ensayos clínicos con 266 pacientes y una duración media del tratamiento de 2,6 años.
Los hallazgos clave incluyen mejoras neurológicas estadísticamente significativas mantenidas durante 6 años, medidas por las Partes II y III de UWDRS. Los pacientes que pasaron de la atención estándar a ALXN1840 mostraron mejoras neurológicas adicionales. El fármaco mostró un perfil de seguridad favorable con menos del 1% de pacientes experimentando eventos adversos neurológicos graves relacionados con el fármaco en más de 645 años-paciente.
Monopar Therapeutics (Nasdaq: MNPR)은 Wilson 질환에 대한 실험 요법 ALXN1840에 대한 새로운 장기 데이터를 미국 신경학회 연례 제150차 총회에서 발표할 예정입니다. 분석은 네 개의 임상시험에서 266명의 환자와 치료 기간의 중앙값 2.6년을 결합합니다.
주요 결과로는 UWDRS 부 II 및 III로 측정된 6년 간 지속된 통계적으로 유의한 신경학적 개선이 포함됩니다. 표준 치료에서 ALXN1840으로 전환한 환자는 추가적인 신경학적 개선을 보였습니다. 이 약물은 약물 관련 신경학적 중대한 이상반응이 645년-환자년 이상에서 1% 미만으로 나타나는 등 안전성 프로파일이 우수하다고 나타났습니다.
Monopar Therapeutics (Nasdaq: MNPR) présentera de nouvelles données à long terme sur son thérapie expérimentale ALXN1840 dans la maladie de Wilson lors de la 150e Réunion annuelle de l'American Neurological Association. L'analyse combine les données de quatre essais cliniques impliquant 266 patients et une durée médiane de traitement de 2,6 ans.
Les résultats clés montrent des améliorations neurologiques statistiquement significatives maintenues sur 6 ans, mesurées par les parties II et III du UWDRS. Les patients ayant basculé de la prise en charge standard à ALXN1840 ont montré des améliorations neurologiques supplémentaires. Le médicament a démontré un profil de sécurité favorable avec moins de 1% des patients présentant des événements indésirables neurologiques graves liés au médicament sur plus de 645 années-patients.
Monopar Therapeutics (Nasdaq: MNPR) wird auf der 150. Jahresversammlung der American Neurological Association neue Langzeitdaten zu seiner experimentellen Behandlung ALXN1840 bei Wilson-Krankheit vorstellen. Die Analyse kombiniert Daten aus vier klinischen Studien mit 266 Patienten und einer mittleren Behandlungsdauer von 2,6 Jahren.
Zentrale Ergebnisse beinhalten statistisch signifikante neurologische Verbesserungen, die über 6 Jahre hinweg anhalten, gemessen an UWDRS-Teile II und III. Patienten, die von der Standardbehandlung zu ALXN1840 wechselten, zeigten zusätzliche neurologische Verbesserungen. Das Medikament zeigte ein günstiges Sicherheitsprofil mit weniger als 1% der Patienten, die schwerwiegende, medikamentenbezogene neurologische Ereignisse erlebten, über mehr als 645 Jahre-Personen hinweg.
Monopar Therapeutics (Nasdaq: MNPR) ستعرض بيانات جديدة طويلة الأمد عن علاجه التجريبي ALXN1840 في مرض وِليسْن في الاجتماع السنوي الـ مئة وخمسون للجمعية العصبية الأمريكية، حيث يجمع التحليل بيانات من أربعة تجارب سريرية شملت 266 مريضًا ومدة علاج وسيطة قدرها 2,6 سنوات.
من بين النتائج الرئيسية وجود تحسنات عصبية ذات دلالة إحصائية مستمرة لمدة 6 سنوات، تقاس بـ UWDRS الأجزاء II وIII. أظهر المرضى الذين انتقلوا من الرعاية القياسية إلى ALXN1840 تحسنًا عصبيًا إضافيًا. أظهر الدواء ملفًا أمنيًا مرغوبًا فيه مع أقل من 1% من المرضى الذين عانوا من أحداث جانبية عصبية خطيرة مرتبطة بالدواء عبر أكثر من 645 سنة-مريض.
Monopar Therapeutics（纳斯达克股票代码：MNPR） 将在第 150 届美国神经学协会年会 上公布其在威尔逊病治疗中的研究性药物 ALXN1840 的长期数据。该分析汇总了来自 四项临床试验、共 266 名患者、平均治疗时长为 2.6 年 的数据。
关键发现包括在 UWDRS 的第 II、III 部分测量的 6 年持续的统计学显著神经学改善。从标准治疗切换到 ALXN1840 的患者显示出额外的神经学改善。该药物显示出有利的安全性资料，在超过 645 人/年 的观察期内，药物相关的神经系统严重不良事件的发生率低于 1%。
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WILMETTE, Ill., Sept. 14, 2025 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced that new data on the long-term neurological efficacy and safety of its investigational therapy ALXN1840 (tiomolybdate choline) for Wilson disease will be presented at the 150th American Neurological Association (ANA) Annual Meeting on September 14-15, 2025. The poster and oral presentations will be delivered by Matthew Lorincz, M.D., Ph.D., Professor of Neurology and Co-Director of the Wilson Disease Center of Excellence at the University of Michigan. Monopar’s poster presentation is available at the following link: https://www.monopartx.com/ALXN1840-ANA-2025-Poster-14-Sep-2025. The oral presentation will be made available online at www.monopartx.com concurrently with Dr. Lorincz’s presentation on September 15, 2025.
The analysis pooled efficacy outcomes from three independent clinical trials (n=255), while safety data included a fourth independent clinical trial (n=266). Median treatment duration with ALXN1840 was approximately 2.6 years for both the efficacy and safety analyses.
The new data presented at ANA highlight the long-term neurological benefit of ALXN1840, and follow the recent presentation of long-term hepatic and systemic efficacy and safety data at the European Association for the Study of the Liver (EASL) International Liver Congress 2025. Together, these findings underscore the potential of ALXN1840 for both the neurological and hepatic manifestations of Wilson disease.
Key findings to be presented at ANA include:
- Sustained Neurological Improvement: Statistically significant neurologic improvement from baseline on the Unified Wilson Disease Rating Scale (“UWDRS”) Part II (patient-reported symptoms) and Part III (clinician-reported symptoms) was sustained over 6 years.
- Crossover Benefit: Patients who crossed over from standard of care (“SoC”) to ALXN1840 showed additional neurological improvement, including a majority of patients who had worsened on SoC demonstrating a reversal on ALXN1840.
- Psychiatric Outcomes: Statistically significant psychiatric improvement from baseline was sustained over multiple years, as measured by the Brief Psychiatric Rating Scale (“BPRS”).
- Consistency Across Trials: Neurological benefit was observed consistently across multiple independent studies.
- Favorable Safety Profile: Across more than 645 patient-years on ALXN1840, less than
1% of patients experienced a drug-related neurological serious adverse event (“SAE”).
“These results are very encouraging for Wilson disease patients, including for those already on standard of care treatment,” said Dr. Matthew Lorincz.
About Monopar Therapeutics Inc.
Monopar Therapeutics is a clinical-stage biopharmaceutical company with late-stage ALXN1840 for Wilson disease, and radiopharmaceutical programs including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers. For more information, visit: www.monopartx.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward-looking statements include statements concerning: that these findings underscore the potential of ALXN1840 for both the neurological and hepatic manifestations of Wilson disease; and that these results are very encouraging for Wilson disease patients, including for those already on standard of care treatment. The forward-looking statements involve risks and uncertainties including, but not limited to: uncertainties related to the regulatory process that Monopar intends to initiate related to ALXN1840 and the outcome thereof; the rate of market acceptance and competitiveness in terms of pricing, efficacy and safety, of any products for which Monopar receives marketing approval, and Monopar’s ability to competitively market any such products as compared to larger pharmaceutical firms; Monopar’s ability to raise sufficient funds in order for the Company to support continued preclinical, clinical, regulatory, precommercial and commercial development of its programs and to make contractual milestone payments, as well as its ability to further raise additional funds in the future to support any existing or future product candidate programs through completion of clinical trials, the approval processes and, if applicable, commercialization; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
Contact:
Monopar Therapeutics Inc.
Investor Relations
Quan Vu
Chief Financial Officer
vu@monopartx.com
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