Monopar Presents New Data and Analyses on Rapidly Improved Copper Balance in Wilson Disease Patients on Tiomolybdate Choline at AASLD - The Liver Meeting® 2025
MWN-AI** Summary
Monopar Therapeutics Inc. recently presented significant findings regarding its drug ALXN1840 (tiomolybdate choline) at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2025 in Washington, D.C. Professor Aftab Ala led the oral presentation focusing on the promising improvements in copper balance among patients with Wilson disease, a genetic disorder that causes excessive copper accumulation in the body.
The Phase 2 ALXN1840-WD-204 copper balance study demonstrated that treatment with ALXN1840 resulted in rapid and sustained enhancements in daily copper excretion. Specifically, the study involved eight patients and revealed that their mean daily copper balance significantly improved compared to pre-treatment levels. Results showed consistent advancement in copper balance during the initial 15 mg daily dosing period (days 1-28), as well as over the entire treatment duration which spanned 39 days and also included alternating doses of 15 mg and daily doses of 30 mg.
In addition to these primary findings, the presentation also included new nonclinical and clinical data underscoring the effectiveness of ALXN1840 in managing copper levels in Wilson disease patients. This research reinforces Monopar’s commitment to addressing unmet medical needs through innovative treatment options.
Monopar Therapeutics, a clinical-stage biopharmaceutical company, is not only focused on Wilson disease but is also developing various radiopharmaceutical programs for imaging and treating advanced cancers. This includes several investigational products in varying stages of the clinical pipeline. However, the company continues to face uncertainties regarding regulatory approvals and market acceptance of its products, highlighting the inherent risks in the pharmaceutical development process. Further information can be obtained from Monopar's official website.
MWN-AI** Analysis
Monopar Therapeutics Inc. (Nasdaq: MNPR) recently presented promising results from its Phase 2 ALXN1840-WD-204 study on ALXN1840 (tiomolybdate choline) at the AASLD Liver Meeting 2025, showcasing its potential in rapidly improving copper balance in Wilson disease patients. The data indicates a significant reduction in daily copper balance, achieved through enhanced fecal copper excretion, signaling a robust treatment response.
From an investment standpoint, this development is noteworthy for several reasons. First, the successful demonstration of efficacy in treating Wilson disease—a condition with few existing treatment options—could position Monopar favorably within a niche market, potentially leading to strong demand upon regulatory approval. Investors should closely monitor the regulatory trajectory of ALXN1840, as the ability to navigate this process smoothly will be critical for market entry.
Furthermore, Monopar’s broader pipeline, which includes radiopharmaceuticals for advanced cancers, demonstrates diversification, mitigating risk. However, potential investors should factor in the inherent uncertainties surrounding clinical development and regulatory approvals, as highlighted in the company's forward-looking statements. Patients and healthcare providers will likely take time to adopt a new treatment, depending on its competitive positioning against existing therapies in terms of safety and efficacy.
For those considering Monopar as an investment, the next few quarters will be crucial. The company needs to ensure not only successful completion of the ongoing clinical trials but also adequate funding for future operations, which could impact stock performance. The recent data enhances the company’s visibility and could lead to increased interest from institutional investors.
In summary, while the recent results are encouraging and suggest a promising future for Monopar, potential investors should remain cautious and stay informed on clinical developments, funding needs, and market acceptance as the situation evolves.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
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
Chief Financial Officer
[email protected]
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FAQ**
What are the potential regulatory challenges that Monopar Therapeutics Inc. MNPR might face in obtaining marketing approval for ALXN1840, considering the uncertainties highlighted in their recent press release?
How does Monopar Therapeutics Inc. MNPR plan to compete with larger pharmaceutical firms regarding the market acceptance and pricing of ALXN1840 for Wilson disease treatment?
Given Monopar Therapeutics Inc. MNPR’s reliance on external funding for clinical development, what strategies are in place to ensure they can raise the necessary capital to support their programs?
Can you provide more details on the significance of the copper balance improvement data presented by Monopar Therapeutics Inc. MNPR at the AASLD conference, particularly in relation to treatment efficacy for Wilson disease?
**MWN-AI FAQ is based on asking OpenAI questions about Monopar Therapeutics Inc. (NASDAQ: MNPR).
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