Articles from Alzheon, Inc.

Alzheon, Inc., a clinical-stage biopharmaceutical company advancing innovative therapeutics and diagnostics for patients with Alzheimer’s disease (AD), today announced it will present new efficacy and safety data from the Phase 2 study long term extension over 3 years, and quantitative systems pharmacology (QSP) analyses for its lead investigational therapy, valiltramiprosate/ALZ-801, during the 18th Clinical Trials on Alzheimer’s Disease (CTAD) conference in San Diego, California.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of investigational therapies and diagnostic assays for patients with Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced the peer-reviewed publication of “Clinical Efficacy, Safety and Imaging Effects of Oral Valiltramiprosate in APOEε4/ε4 Homozygotes with Early Alzheimer’s Disease: Results of Phase 3, Randomized, Double-Blind, Placebo-Controlled, 78-Week APOLLOE4 Trial” in the scientific journal Drugs. The full text can be accessed at https://link.springer.com/article/10.1007/s40265-025-02250-5. This publication provides an overview of effects of valiltramiprosate in the APOLLOE4 Phase 3 trial in patients with Early AD, comprised of Mild Cognitive Impairment (MCI) and Mild AD dementia, who carry two copies of the apolipoprotein E ε4 allele (APOE4/4 homozygotes).

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of investigational therapies and diagnostic assays for patients with Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced it will present new data on its lead investigational product, valiltramiprosate, highlighting the differentiated mode of action that acts upstream in the amyloid pathway, blocking formation of neurotoxic amyloid oligomers that drive disease progression. Valiltramiprosate showed positive clinical and volumetric MRI effects in patients with Mild Cognitive Impairment (MCI) who carry one or two copies of the ε4 allele of the apolipoprotein E gene (APOE3/4 heterozygotes and APOE4/4 homozygotes, respectively). The first of-its-kind data will be presented in a symposium during the Alzheimer’s Association International Conference (AAIC) in Toronto, Canada.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of investigational therapies and diagnostic assays for patients with Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced topline results from the pivotal APOLLOE4 Phase 3 trial of oral valiltramiprosate/ALZ-801 in patients with Early AD comprised of Mild Cognitive Impairment (MCI) and Mild AD dementia, who carry two copies of the ε4 allele of the apolipoprotein E gene (APOE4/4 homozygotes). Valiltramiprosate is an investigational oral treatment in Phase 3 clinical development that inhibits formation of soluble neurotoxic amyloid aggregates and acts upstream in the amyloid cascade. APOLLOE4 Phase 3 trial results were presented on April 1, 2025, at the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD) in Vienna.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of investigational therapies and diagnostic assays for patients with Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced it will present topline results from the pivotal APOLLOE4 Phase 3 trial of oral valiltramiprosate/ALZ-801 in patients with early AD who carry two copies of the ε4 allele of the apolipoprotein E gene (APOE4/4 homozygotes). The first-of-its-kind data will be presented in a symposium during the International Conference on Alzheimer’s and Parkinson’s Disease and Related Neurological Disorders (ADPD) in Vienna, Austria.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced the publication of two new peer-reviewed scientific papers focused on advancement of understanding of AD and need for new treatments.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it has appointed Muneer A. Satter, JD, MBA to its Board of Directors.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and related neurodegenerative disorders, today announced a new scientific publication describing its APOLLOE4 Phase 3 study, the first Phase 3 trial focused on AD patients carrying two copies of apolipoprotein ε4 allele (APOE4/4 homozygotes), a population with pressing unmet medical need for effective and safe treatments.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and related neurodegenerative disorders, today announced its participation in the Alzheimer’s Association International Conference (AAIC) in Philadelphia, held from July 28 to August 1, 2024.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced two scientific publications of results from the Phase 2 biomarker trial showing statistically significant and clinically relevant reduction in plasma biomarkers of neurodegeneration, preservation of brain volume, and positive cognitive effects in Early AD patients who are carriers of apolipoprotein ε4 allele (APOE4) following 24 months of treatment with investigational oral agent ALZ-801/valiltramiprosate.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it has raised $100 million in Series E financing, led by Alerce Medical Technology Partners. Alzheon previously raised $50 million through a Series D financing round in 2022.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it has appointed Gino Santini to its Board of Directors.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced the dosing of the first patient in a long-term extension of the ongoing pivotal APOLLOE4 Phase 3 trial of 265 mg oral tablet of ALZ-801/valiltramiprosate, administered twice daily, in Early AD subjects carrying two copies of the ε4 allele of the apolipoprotein E gene (APOE4/4 homozygotes). Early AD includes patients with mild cognitive impairment due to AD (MCI) and mild AD.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that the United States Court of Appeals for the Federal Circuit affirmed the U.S. Patent Office decision invalidating Risen (Suzhou) Pharmaceutical Technology Co., Ltd.’s patent on isotopically enriched forms of ALZ-801/valiltramiprosate. The decision was affirmed without discussion by the Federal Circuit Court (Case No. 22-2232).

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced the publication of a peer-reviewed research paper, “The Single Toxin Origin of Alzheimer’s Disease and Other Neurodegenerative Disorders Enables Targeted Approach to Treatment and Prevention” in the Special Issue Dementia: From Molecular Pathophysiology to Novel Therapeutic Approaches of the International Journal of Molecular Sciences, available through open access at: https://doi.org/10.3390/ijms25052727.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and related neurodegenerative disorders, today announced its participation in the upcoming International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD) in Lisbon, Portugal from March 5–9, 2024.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that its Founder, President & CEO Dr. Martin Tolar has been awarded the Eliška and Zdeněk Strmiska Award from the Alzheimer’s Foundation for significant contribution towards the research and treatment of Alzheimer’s disease.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced its participation in the Nobel Forum “Challenges for Implementation of New Alzheimer’s Disease Treatments” covering Alzheimer’s therapeutics for the future, at the Karolinska Institute in Stockholm, Sweden from January 18-19.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it has strengthened its commercial organization with the promotion of Glenn E. Pauly to Chief Commercial Officer and the appointments of Dina Lynch to Vice President of Market Access, and Nate Greene to Vice President of Brand Marketing. These appointments will support preparations for the commercial launch of investigational agent ALZ-801, which is currently being evaluated in the APOLLOE4 Phase 3 trial in Early Alzheimer’s disease patients with two copies of the APOE4 gene.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and related neurodegenerative disorders, today announced its participation in the upcoming Truist Securities BioPharma Symposium in New York City, New York on November 8-9, 2023. Alzheon executive management will be available to meet with qualified members of the investor community who are registered to attend the conference.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and related neurodegenerative disorders, today announced its participation in the upcoming Clinical Trials in Alzheimer’s Disease (CTAD) conference in Boston, Massachusetts from October 24-27, 2023.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and related neurodegenerative disorders, today announced that the company will be presenting at upcoming industry and investor conferences.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and related neurodegenerative disorders, today announced statistically significant and clinically relevant reduction in plasma biomarkers of neurodegeneration, preservation of brain volume, and positive cognitive effects in Early AD patients who are carriers of apolipoprotein ε4 allele (APOE4) following 24 months of treatment with investigational agent ALZ-801 in the Phase 2 biomarker trial.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it will be presenting baseline imaging characteristics from its ongoing APOLLOE4 Phase 3 clinical trial and new correlation analyses from the Phase 2 biomarker study evaluating ALZ-801 oral tablet at the upcoming Alzheimer's Association International Conference, to be held from July 16 – 20, 2023 in Amsterdam, Netherlands.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it will be presenting baseline imaging characteristics from ongoing APOLLOE4 Phase 3 clinical trial and 12-month results from the Phase 2 biomarker study evaluating ALZ-801 oral tablet at the upcoming American Academy of Neurology (AAN) Conference to be held from April 22 – April 27, 2023 in Boston, Massachusetts.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it will be presenting interim findings from an ongoing Phase 2 study evaluating ALZ-801 tablet at the upcoming AD/PD 2023 Conference to be held from March 28 – April 1, 2023 in Gothenburg, Sweden.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it has achieved the enrollment target of 325 patients in its pivotal APOLLOE4 Phase 3 trial evaluating oral ALZ-801 in Early AD patients, who carry two copies of the ε4 allele of apolipoprotein E gene (APOE4/4 homozygotes). These patients represent approximately 15% of all AD patients, have an earlier onset of AD and higher risk of rapid disease progression, and carry a high burden of neurotoxic soluble beta amyloid oligomers.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it will be presenting new clinical trial data at the 15th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference to be held from November 29 – December 2, 2022 in San Francisco, CA, USA.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today reported statistically significant and clinically relevant plasma biomarker reduction, robust preservation of brain volume, and positive memory effects in Alzheimer’s patients following 12 months of treatment with investigational agent ALZ-801 in its Phase 2 biomarker trial.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced the appointment of Glenn E. Pauly as Head of Commercial.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it will be presenting at the 2022 Alzheimer’s Association International Conference (AAIC) to be held on July 31 – August 4, 2022 in San Diego, California, USA.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it will be presenting at the 4th International Trisomy 21 Research Society Conference (T21RS conference) to be held on June 9-12, 2022 in Long Beach, California, USA.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it has completed an oversubscribed $50 million Series D round from private and institutional investors.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced the appointments of Susan Flint as Vice President of Clinical Operations, Patrick Kesslak, PhD, as Vice President of Clinical Development & Medical Affairs, and Erwan de Naurois as Vice President of Finance.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today reported a clinically relevant and statistically significant plasma biomarker reduction and memory improvement in Alzheimer’s patients following 6 months of treatment with oral tablet ALZ-801 (valiltramiprosate) in its Phase 2 biomarker trial.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that Martin Tolar, MD, PhD, the company’s Founder, President and Chief Executive Officer will present at the H.C. Wainwright Bioconnect Conference on January 10th. The presentation will be available live on-demand from 1:00 PM EST on January 10th until the end of the conference on January 13th.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it will be presenting two scientific posters at the 14th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference to be held on November 9-12, 2021 in Boston, MA, USA.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that Martin Tolar, MD, PhD, company’s Founder, President and Chief Executive Officer will present at the H.C. Wainwright Annual Global Investment Conference on September 13th. Presentation will be available live on-demand from 7:00 AM EST until the end of the conference on September 15th.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced the appointment of Adem Albayrak as Head of Operations, and Earvin Liang, PhD, as Vice President of Clinical Development.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced the publication of a peer-reviewed research paper, “Neurotoxic Soluble Amyloid Oligomers Drive Alzheimer’s Pathogenesis and Represent a Clinically Validated Target for Slowing Disease Progression,” in the Special Issue Alzheimer’s Disease: Role and Structure of Soluble Oligomers of the International Journal of Molecular Sciences, available through open access at: https://doi.org/10.3390/ijms22126355.

Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it has achieved enrollment target of 80 patients for its Phase 2 biomarker study of ALZ-801 in Early AD patients, who carry either one or two copies of the ε4 allele of apolipoprotein E gene (APOE3/4 heterozygotes and APOE4/4 homozygotes, respectively). These patients represent two-thirds of all AD patients, have an earlier onset of AD and higher risk of rapid disease progression, and carry a high burden of neurotoxic soluble beta amyloid oligomers.

Alzheon, Inc., a clinical-stage biopharmaceutical company focused on developing new medicines for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced the dosing of the first patient in its APOLLOE4 Phase 3 study evaluating the efficacy and safety of ALZ-801 in Early AD patients carrying two copies of the ε4 allele of the apolipoprotein E gene (APOE4/4 homozygotes). AD patients with this genetic profile present with an early onset and rapid progression of the disease and are responsive to drug agents that remove or inhibit pathogenic amyloid oligomers. ALZ-801 is an oral treatment that has been shown in preclinical mechanistic studies to fully inhibit the formation of neurotoxic soluble beta amyloid oligomers at the Phase 3 clinical dose.

Alzheon, Inc., a clinical-stage biopharmaceutical company focused on developing new medicines for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it has entered into a collaboration and license agreement with the Institute of Organic Chemistry and Biochemistry of the Czech Academy of Sciences (IOCB) to develop the first clinical assay to measure neurotoxic beta amyloid (amyloid, Aβ) oligomers in human cerebrospinal fluid (CSF). Under the collaboration agreement, IOCB will apply Alzheon’s technology for detecting oligomers into a customized clinical assay in human CSF, to be developed by the IOCB and commercialized by Alzheon. This initiative builds on successfully completed feasibility studies performed over the past year by the two organizations.