Monopar Presents New Data and Analyses on Rapidly Improved Copper Balance in Wilson Disease Patients on Tiomolybdate Choline at AASLD - The Liver Meeting® 2025
Monopar (Nasdaq: MNPR) presented new Phase 2 ALXN1840-WD-204 data at AASLD The Liver Meeting® 2025 on Nov 9, 2025 showing that ALXN1840 (tiomolybdate choline) produced a rapid, sustained improvement in daily copper balance in Wilson disease patients, driven primarily by increased fecal copper excretion.
The study cohort (n=8) showed a mean daily copper balance that was significantly lower vs pre-treatment baseline. Improvement occurred during the initial 15 mg once-daily dosing period (days 1–28) and across the full treatment window (days 1–39), which included 15 mg every other day or 30 mg once-daily dosing. Presentation materials and the abstract are available online.
Monopar (Nasdaq: MNPR) ha presentato nuovi dati di fase 2 ALXN1840-WD-204 al AASLD The Liver Meeting® 2025 il 9 novembre 2025, che mostrano che ALXN1840 (tiomolibdate di colina) ha prodotto un rapido e sostenuto miglioramento dell'equilibrio giornaliero del rame nei pazienti con malattia di Wilson, guidato principalmente dall'aumento dell'escrezione fecale di rame.
La coorte dello studio (n=8) ha mostrato un equilibrio medio giornaliero del rame significativamente inferiore rispetto alla linea di base prima del trattamento. Il miglioramento si è verificato durante il periodo di dosaggio iniziale di 15 mg una volta al giorno (giorni 1–28) e in tutta la finestra di trattamento (giorni 1–39), che includeva 15 mg ogni due giorni o 30 mg una volta al giorno. Il materiale di presentazione e l'abstract sono disponibili online.
Monopar (Nasdaq: MNPR) presentó nuevos datos de fase 2 ALXN1840-WD-204 en AASLD The Liver Meeting® 2025 el 9 de noviembre de 2025, que muestran que ALXN1840 (tiomolibdate de colina) produjo una mejora rápida y sostenida en el equilibrio diario de cobre en pacientes con enfermedad de Wilson, impulsada principalmente por un aumento de la excreción fecal de cobre.
La cohorte del estudio (n=8) mostró un equilibrio diario medio de cobre significativamente menor en comparación con la línea de base previa al tratamiento. La mejora ocurrió durante el periodo de dosificación inicial de 15 mg una vez al día (días 1–28) y a lo largo de toda la ventana de tratamiento (días 1–39), que incluyó 15 mg cada dos días o 30 mg una vez al día. El material de la presentación y el abstract están disponibles en línea.
Monopar (Nasdaq: MNPR)는 2025년 11월 9일 AASLD The Liver Meeting® 2025에서 ALXN1840-WD-204의 2상 데이터를 발표했습니다. ALXN1840 (티오몰리베이트 콜린)은 윌슨병 환자에서 매일 구리 균형을 빠르게 지속적으로 개선시켰으며, 주로 대변으로의 구리 배출 증가에 의해 주도되었습니다.
연구 코호트(n=8)는 치료 전 기준선 대비 통계적으로 유의하게 낮은 일일 구리 균형을 보였습니다. 개선은 초기 15 mg 1일 1회 복용 기간(일 1–28) 동안 및 전체 치료 기간(일 1–39) 동안 나타났으며, 여기에는 15 mg을 매 이틀 복용하거나 30 mg을 매일 1회 복용하는 구성이 포함되었습니다. 발표 자료와 초록은 온라인에서 확인할 수 있습니다.
Monopar (Nasdaq: MNPR) a présenté de nouveaux données de phase 2 ALXN1840-WD-204 lors de l’AASLD The Liver Meeting® 2025 le 9 novembre 2025, montrant que ALXN1840 (tiomolybdate de choline) a produit une amélioration rapide et soutenue de l’équilibre quotidien du cuivre chez les patients atteints de la maladie de Wilson, principalement due à une augmentation de l’excrétion fécale du cuivre.
La cohorte de l’étude (n=8) a montré un équilibre quotidien moyen du cuivre significativement inférieur par rapport à la ligne de base avant le traitement. L’amélioration s’est produite pendant la période de dosage initial de 15 mg une fois par jour (jours 1–28) et tout au long de la fenêtre de traitement (jours 1–39), qui comprenait 15 mg tous les deux jours ou 30 mg une fois par jour. Le matériel de présentation et l’abstract sont disponibles en ligne.
Monopar (Nasdaq: MNPR) präsentierte neue Phase-2-Daten der ALXN1840-WD-204 auf der AASLD The Liver Meeting® 2025 am 9. November 2025 und zeigte, dass ALXN1840 (Tiomolybdate-Cholin) eine schnelle, anhaltende Verbesserung des täglichen Kupfer-Gleichgewichts bei Wilson-Krankheit-Patienten bewirkte, hauptsächlich getrieben durch eine erhöhte Ausscheidung von Kupfer über den Stuhl.
Die Studienkohorte (n=8) zeigte ein mittleres tägliches Kupfer-Gleichgewicht, das signifikant niedriger war als der Præ-Behandlungs-Baseline. Die Verbesserung trat während der initialen 15 mg-Dosierungsphase einmal täglich (Tage 1–28) und über das gesamte Behandlungsfenster (Tage 1–39) hinweg auf, das 15 mg jeden zweiten Tag oder 30 mg einmal täglich umfasste. Präsentationsmaterialien und das Abstract sind online verfügbar.
Monopar (ناسداك: MNPR) قدمت بيانات جديدة من المرحلة الثانية ALXN1840-WD-204 في اجتماع AASLD The Liver Meeting® 2025 في 9 نوفمبر 2025، مما أظهر أن ALXN1840 (تيوموليبدات كولين) أدى إلى تحسن سريع وثابت في توازن النحاس اليومي لدى مرضى داء ويلسون، مدفوعاً بشكل رئيسي بزيادة إخراج النحاس في البراز.
أظهرت عينة الدراسة (العدد = 8) توازناً يومياً للنحاس أقل بشكل دال إحصائياً مقارنة بخط الأساس قبل العلاج. حدث التحسن خلال فترة الجرعة الأولية 15 ملغ مرة يومياً (الأيام 1–28) وعلى مدى نافذة العلاج الكلية (الأيام 1–39)، والتي شملت 15 ملغ كل يومين أو 30 ملغ مرة واحدة يومياً. المواد العرضية والملخص متاحان عبر الإنترنت.
- Mean daily copper balance significantly lower vs pre-treatment baseline
- Improvement observed during days 1–28 initial 15 mg once-daily dosing
- Improvement sustained over full treatment duration days 1–39
- Primary mechanism identified: increased fecal copper excretion
- Small sample size: n=8 in reported ALXN1840 cohort
WILMETTE, Ill., Nov. 09, 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, is presenting new data and analyses today from the Phase 2 ALXN1840-WD-204 copper balance study at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2025, taking place in Washington, D.C., from November 7-11, 2025.
In an oral presentation titled “Rapidly Improved Cu Balance in Wilson Disease Patients on Tiomolybdate Choline,” Professor Aftab Ala, MBBS, M.D., FRCP, Ph.D., Professor of Hepatology and Consultant Hepatologist at the Institute of Liver Studies at King’s College Hospital in London, will be sharing results showing that treatment with ALXN1840 (tiomolybdate choline) led to a rapid and sustained improvement in daily copper balance in patients with Wilson disease, primarily through increased fecal copper excretion.
The mean daily copper balance among patients treated with ALXN1840 in the study (n=8) was significantly lower - indicating improvement - compared with their pre-treatment baseline. Copper balance improved both during the initial 15 mg once-daily dosing period (days 1-28) and over the entire treatment duration (days 1-39), which included patients receiving either 15 mg every other day or 30 mg once daily. Additional new nonclinical and clinical data supporting these findings from the ALXN1840-WD-204 study will also be presented.
The presentation materials are available on Monopar’s website, and the abstract can be accessed on the AASLD conference website.
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. 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
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vu@monopartx.com
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