Alzamend Neuro Enrolls First Patient in its Phase II Clinical Trial of AL001 “Lithium in Brain” Study Taking Place at Massachusetts General Hospital
Alzamend Neuro (NASDAQ: ALZN) has enrolled its first patient in a Phase II clinical trial for AL001, a novel lithium formulation, at Massachusetts General Hospital. The study aims to compare AL001's brain absorption and blood levels against marketed lithium carbonate in healthy subjects, with topline data expected by year-end 2025.
AL001 shows promise in delivering lithium more effectively to the brain while maintaining lower blood levels, potentially eliminating the need for therapeutic drug monitoring (TDM). Previous mouse studies demonstrated better brain absorption with reduced systemic exposure. The treatment targets multiple conditions, including Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD, potentially benefiting over 43 million Americans.
Alzamend Neuro (NASDAQ: ALZN) ha arruolato il suo primo paziente in uno studio clinico di Fase II per AL001, una nuova formulazione di litio, presso il Massachusetts General Hospital. Lo studio mira a confrontare l'assorbimento cerebrale e i livelli ematici di AL001 rispetto al carbonato di litio già in commercio in soggetti sani, con dati principali attesi entro la fine del 2025.
AL001 mostra potenzialità nel veicolare il litio in modo più efficace al cervello mantenendo livelli ematici più bassi, eliminando così la necessità di monitoraggio terapeutico del farmaco (TDM). Studi precedenti su topi hanno dimostrato un migliore assorbimento cerebrale con una minore esposizione sistemica. Il trattamento è rivolto a diverse patologie, tra cui morbo di Alzheimer, disturbo bipolare, disturbo depressivo maggiore e PTSD, potenzialmente beneficiando oltre 43 milioni di americani.
Alzamend Neuro (NASDAQ: ALZN) ha inscrito a su primer paciente en un ensayo clínico de Fase II para AL001, una nueva formulación de litio, en el Massachusetts General Hospital. El estudio busca comparar la absorción cerebral y los niveles sanguíneos de AL001 frente al carbonato de litio comercializado en sujetos sanos, con datos principales esperados para finales de 2025.
AL001 muestra potencial para entregar litio de manera más eficaz al cerebro manteniendo niveles sanguíneos más bajos, posiblemente eliminando la necesidad de monitoreo terapéutico del fármaco (TDM). Estudios previos en ratones demostraron mejor absorción cerebral con menor exposición sistémica. El tratamiento apunta a múltiples condiciones, incluyendo enfermedad de Alzheimer, trastorno bipolar, trastorno depresivo mayor y TEPT, beneficiando potencialmente a más de 43 millones de estadounidenses.
Alzamend Neuro (NASDAQ: ALZN)는 매사추세츠 종합병원에서 AL001이라는 새로운 리튬 제형에 대한 2상 임상시험에 첫 환자를 등록했습니다. 이 연구는 건강한 대상자들을 대상으로 AL001의 뇌 흡수율과 혈중 농도를 시판 중인 탄산리튬과 비교하는 것을 목표로 하며, 주요 데이터는 2025년 말까지 발표될 예정입니다.
AL001은 혈중 농도는 낮게 유지하면서 리튬을 뇌에 더 효과적으로 전달할 가능성을 보여주어 치료 약물 모니터링(TDM)의 필요성을 없앨 수 있습니다. 이전 쥐 실험에서는 전신 노출을 줄이면서 뇌 흡수가 더 우수하다는 결과가 나왔습니다. 이 치료법은 알츠하이머병, 양극성 장애, 주요 우울장애, PTSD 등 여러 질환을 대상으로 하며, 4,300만 명 이상의 미국인에게 잠재적인 혜택을 제공할 수 있습니다.
Alzamend Neuro (NASDAQ : ALZN) a recruté son premier patient dans un essai clinique de phase II pour AL001, une nouvelle formulation de lithium, au Massachusetts General Hospital. L'étude vise à comparer l'absorption cérébrale et les niveaux sanguins d'AL001 par rapport au carbonate de lithium commercialisé chez des sujets sains, avec données principales attendues d'ici fin 2025.
AL001 montre un potentiel pour délivrer le lithium plus efficacement au cerveau tout en maintenant des niveaux sanguins plus bas, ce qui pourrait éliminer le besoin de surveillance thérapeutique du médicament (TDM). Des études antérieures chez la souris ont démontré une meilleure absorption cérébrale avec une exposition systémique réduite. Le traitement cible plusieurs affections, notamment la maladie d'Alzheimer, le trouble bipolaire, le trouble dépressif majeur et le SSPT, pouvant potentiellement bénéficier à plus de 43 millions d'Américains.
Alzamend Neuro (NASDAQ: ALZN) hat seinen ersten Patienten in einer Phase-II-Studie für AL001, eine neuartige Lithium-Formulierung, am Massachusetts General Hospital eingeschlossen. Die Studie zielt darauf ab, die Aufnahme von AL001 im Gehirn und die Blutspiegel mit dem auf dem Markt befindlichen Lithiumcarbonat bei gesunden Probanden zu vergleichen, wobei Hauptdaten bis Ende 2025 erwartet werden.
AL001 zeigt vielversprechende Ergebnisse bei der effektiveren Abgabe von Lithium ins Gehirn bei gleichzeitig niedrigeren Blutspiegeln, was die Notwendigkeit einer therapeutischen Medikamentenüberwachung (TDM) potenziell überflüssig macht. Frühere Mausstudien zeigten eine bessere Gehirnaufnahme bei reduzierter systemischer Exposition. Die Behandlung richtet sich gegen mehrere Erkrankungen, darunter Alzheimer, bipolare Störung, Major Depression und PTSD, und könnte über 43 Millionen Amerikanern zugutekommen.
- None.
- Study is only in Phase II and currently testing healthy subjects, not patients
- Results from previous mouse studies may not translate to humans
- Final data not expected until end of 2025
Insights
Alzamend has started Phase II trials for AL001, potentially offering safer lithium delivery to the brain with data expected by year-end.
Alzamend Neuro has reached a significant clinical milestone with the enrollment of their first patient in a Phase II study for their lead candidate AL001. This trial specifically examines how AL001 distributes lithium to the brain compared to conventional lithium carbonate products. The study is taking place at Massachusetts General Hospital, a premier research institution that adds credibility to this clinical program.
What makes AL001 potentially groundbreaking is its pharmacokinetic profile. Previous preclinical studies in mice demonstrated that AL001 achieves better brain absorption while maintaining lower blood lithium levels. This is crucial because conventional lithium's narrow therapeutic window necessitates frequent therapeutic drug monitoring (TDM) to prevent toxicity, which creates a significant treatment burden for both patients and clinicians.
This head-to-head pharmacokinetic study in healthy subjects will establish important baseline data to guide future clinical development across multiple indications: Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD. The company expects topline data by year-end, which will be a material catalyst for evaluating AL001's potential.
If AL001 can indeed deliver lithium more effectively to the brain while reducing systemic exposure, it could address the fundamental limitations that have restricted lithium's widespread use despite its established efficacy. Eliminating the need for therapeutic drug monitoring would represent a significant advance in patient care and potentially expand lithium's utility across multiple psychiatric and neurological conditions affecting millions of patients.
- Topline data expected by year end
- Head-to-head studies of AL001 versus a marketed lithium carbonate product will be conducted for comparisons of lithium blood and brain/brain-structure pharmacokinetics in healthy subjects
ATLANTA, May 19, 2025 (GLOBE NEWSWIRE) -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced the enrollment of the first patient of its first Phase II clinical study of AL001, in healthy human subjects. This study follows the successful development of a novel head coil by Tesla Dynamic Coils BV, a key component of the clinical trial.
In collaboration with Massachusetts General Hospital as its clinical trial site, Alzamend aims to explore the unique properties of AL001 and its potential to deliver lithium more effectively in the brain compared to marketed lithium salts. The study in healthy human subjects will serve as a baseline and assist Alzamend determine the best path forward in Alzheimer’s, BD, MDD and PTSD patients by demonstrating AL001’s targeted effectiveness and reduced systemic side effects. Previous studies in mice have shown that AL001 ensures better brain absorption while maintaining lower levels of lithium in the blood, paving the way for safer and more efficient treatments.
By offering a treatment that potentially eliminates the need for lithium therapeutic drug monitoring (“TDM”), AL001 could revolutionize care for vulnerable patient populations and improve treatment outcomes. Lithium, renowned for its efficacy as a first-line therapy for manic episodes and maintenance in BD, has long been underutilized due to the complexities of TDM. Current U.S. Food and Drug Administration-approved lithium salts are limited by a narrow therapeutic window that requires regular TDM of plasma lithium levels and blood chemistry by a clinician to mitigate adverse events. Since conventional lithium salts are eliminated relatively quickly, multiple administrations throughout the day are required to safely reach therapeutic plasma concentrations. By reducing the systemic burden, Alzamend’s novel AL001 formulation could signify a major shift in managing conditions like Alzheimer’s, by minimizing risks associated with kidney and thyroid side effects traditionally linked to lithium therapies.
“We are pleased to announce the enrollment of the first patient in our clinical study evaluating AL001, with topline data anticipated by the end of the year,” stated Stephan Jackman, Chief Executive Officer of Alzamend. “AL001 has the potential to transform the treatment landscape for over 43 million Americans affected by Alzheimer’s, BD, MDD and PTSD. By offering improved safety, enhanced central nervous system targeting, and eliminating the requirement for TDM, AL001 aims to address significant limitations of current lithium therapies and advance patient care, with the goal of improving both treatment efficacy and quality of life.”
About AL001
AL001 is a novel lithium-delivery system that has the potential to provide the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. Results from Alzamend’s completed Phase IIA multiple-ascending dose study of AL001 in Alzheimer’s patients and healthy subjects identified a maximum tolerated dose (“MTD”), as assessed by an independent safety review committee. This MTD is designed to be unlikely to require TDM while providing lithium at a relatively modest but effective dose. AL001 is designed to favorably distribute lithium in the brain resulting in lower exposure of other body organs and an improved safety profile compared to currently marketed lithium salts. This can serve to mitigate or obviate the disadvantageously low ceiling for toxicity of marketed lithium salts that has limited their usefulness to patients and prescribers.
About Alzamend Neuro
Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s, BD, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 - a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, salicylate and L-proline, and ALZN002 - a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s by removing beta-amyloid from the brain. The latter is a second-generation active-immunity approach designed to mitigate the disadvantages of approved passive immunity marketed antibody products, particularly by reducing the required frequency and costs of dosing associated with antibody products. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend’s business and financial results are included in Alzamend’s filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend’s website at www.Alzamend.com.
Contacts:
Email: Info@Alzamend.com or call: 1-844-722-6333
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/93916c45-f608-432d-9d92-e0016ed89196
FAQ
What is the purpose of ALZN's Phase II AL001 clinical trial?
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What advantages does ALZN's AL001 have over traditional lithium treatments?
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