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Positive
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
Negative
Small sample size: n=8 in reported ALXN1840 cohort
11/09/2025 – 09:00 AM
WILMETTE, Ill., Nov. 09, 2025 (GLOBE NEWSWIRE) — Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company, is presenting new data from its Phase 2 ALXN1840-WD-204 copper balance study at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2025 in Washington, D.C. The data offers insights into the potential of ALXN1840 in treating Wilson disease, a rare genetic disorder characterized by copper accumulation in the body.
Professor Aftab Ala, MBBS, M.D., FRCP, Ph.D., from King’s College Hospital in London, presented findings that ALXN1840 (tiomolybdate choline) led to a rapid and sustained improvement in daily copper balance in Wilson disease patients. This improvement was primarily driven by increased fecal copper excretion, a key mechanism for removing excess copper from the body. The oral presentation was titled “Rapidly Improved Cu Balance in Wilson Disease Patients on Tiomolybdate Choline.”
The study, involving a small cohort (n=8), showcased a significant reduction in mean daily copper balance in patients treated with ALXN1840 compared to their pre-treatment baseline. Notably, the improvement was observed during both the initial 15 mg once-daily dosing period (days 1-28) and throughout the entire treatment duration (days 1-39), which included patients receiving either 15 mg every other day or 30 mg once daily. While the results are promising, the small sample size necessitates further investigation in larger, more diverse patient populations to confirm these findings and assess long-term safety and efficacy. The company also presented additional new nonclinical and clinical data supporting these findings from the ALXN1840-WD-204 study.
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 RelationsQuan VuChief Financial Officer
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FAQ
What did Monopar announce about ALXN1840 (MNPR) on November 9, 2025?
Monopar presented Phase 2 data showing rapid, sustained improvement in daily copper balance in Wilson disease patients treated with ALXN1840.
How many patients were included in the ALXN1840-WD-204 copper balance analysis (MNPR)?
The reported cohort comprised n=8 patients in the ALXN1840-treated group.
What dosing produced improvement in copper balance in the MNPR study?
Improvement occurred during the initial 15 mg once-daily period (days 1–28) and across days 1–39 including 15 mg every other day or 30 mg once daily.
What was the primary mechanism for copper balance improvement reported by Monopar (MNPR)?
The company reported increased fecal copper excretion as the primary driver of improved copper balance.
Where can investors access the ALXN1840-WD-204 presentation and abstract for MNPR?
Presentation materials are available on Monopar’s website and the abstract is on the AASLD conference website.
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