Alzamend Neuro Announces Dosing of 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 initiated dosing in its Phase II clinical trial of AL001, a novel lithium formulation, at Massachusetts General Hospital. The study aims to compare AL001's brain absorption and blood levels against existing lithium carbonate products in healthy subjects. Topline data is expected by the end of 2025.
AL001 represents a potential breakthrough in lithium-based treatments, as previous mouse studies demonstrated improved brain absorption with lower blood levels, potentially eliminating the need for therapeutic drug monitoring (TDM). This advancement could benefit over 43 million Americans affected by Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD.
The trial follows the successful development of a novel head coil by Tesla Dynamic Coils BV, which is crucial for the study's execution.Alzamend Neuro (NASDAQ: ALZN) ha iniziato la somministrazione nella sua sperimentazione clinica di Fase II di 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 con quelli dei prodotti esistenti a base di carbonato di litio in soggetti sani. I dati principali sono attesi entro la fine del 2025.
AL001 rappresenta una possibile svolta nei trattamenti a base di litio, poiché studi precedenti su topi hanno dimostrato un miglior assorbimento cerebrale con livelli ematici più bassi, potenzialmente eliminando la necessità di monitoraggio terapeutico del farmaco (TDM). Questo progresso potrebbe beneficiare oltre 43 milioni di americani affetti da Alzheimer, disturbo bipolare, disturbo depressivo maggiore e PTSD.
La sperimentazione segue lo sviluppo con successo di una nuova bobina per la testa da parte di Tesla Dynamic Coils BV, elemento cruciale per l'esecuzione dello studio.
Alzamend Neuro (NASDAQ: ALZN) ha iniciado la dosificación en su ensayo clínico de Fase II de AL001, una novedosa formulación de litio, en el Massachusetts General Hospital. El estudio busca comparar la absorción cerebral y los niveles sanguíneos de AL001 con los productos existentes de carbonato de litio en sujetos sanos. Se esperan datos principales para finales de 2025.
AL001 representa un posible avance en los tratamientos basados en litio, ya que estudios previos en ratones demostraron una mejor absorción cerebral con niveles sanguíneos más bajos, lo que podría eliminar la necesidad de monitoreo terapéutico del medicamento (TDM). Este avance podría beneficiar a más de 43 millones de estadounidenses afectados por la enfermedad de Alzheimer, trastorno bipolar, trastorno depresivo mayor y TEPT.
El ensayo sigue al exitoso desarrollo de una nueva bobina para la cabeza por parte de Tesla Dynamic Coils BV, fundamental para la realización del estudio.
Alzamend Neuro (NASDAQ: ALZN)가 매사추세츠 종합병원에서 새로운 리튬 제형인 AL001의 2상 임상시험 투약을 시작했습니다. 이 연구는 건강한 피험자를 대상으로 AL001의 뇌 흡수율과 혈중 농도를 기존 탄산리튬 제품과 비교하는 것을 목표로 합니다. 주요 결과는 2025년 말까지 발표될 예정입니다.
AL001은 이전 쥐 연구에서 혈중 농도는 낮으면서도 뇌 흡수가 개선된 것으로 나타나 치료 약물 모니터링(TDM)의 필요성을 없앨 수 있는 잠재적 혁신적인 리튬 기반 치료제입니다. 이 진전은 알츠하이머병, 양극성 장애, 주요 우울장애, PTSD로 고통받는 미국인 4,300만 명 이상에게 혜택을 줄 수 있습니다.
이번 임상시험은 Tesla Dynamic Coils BV가 성공적으로 개발한 새로운 헤드 코일을 기반으로 진행되며, 이는 연구 수행에 필수적입니다.
Alzamend Neuro (NASDAQ : ALZN) a commencé l'administration dans son essai clinique de phase II d'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 aux produits existants à base de carbonate de lithium chez des sujets sains. Les données principales sont attendues d'ici la fin 2025.
AL001 représente une avancée potentielle dans les traitements à base de lithium, car des études antérieures chez la souris ont montré une meilleure absorption cérébrale avec des niveaux sanguins plus faibles, ce qui pourrait éliminer le besoin de surveillance thérapeutique du médicament (TDM). Cette avancée pourrait bénéficier à plus de 43 millions d'Américains atteints de la maladie d'Alzheimer, de troubles bipolaires, de troubles dépressifs majeurs et de PTSD.
L'essai fait suite au développement réussi d'une nouvelle bobine pour la tête par Tesla Dynamic Coils BV, élément crucial pour la réalisation de l'étude.
Alzamend Neuro (NASDAQ: ALZN) hat mit der Dosierung in seiner Phase-II-Studie von AL001, einer neuartigen Lithium-Formulierung, am Massachusetts General Hospital begonnen. Die Studie zielt darauf ab, die Gehirnaufnahme und Blutspiegel von AL001 mit bestehenden Lithiumcarbonat-Produkten bei gesunden Probanden zu vergleichen. Erste Ergebnisse werden bis Ende 2025 erwartet.
AL001 stellt einen potenziellen Durchbruch in der Lithium-basierten Behandlung dar, da frühere Mäusestudien eine verbesserte Gehirnaufnahme bei niedrigeren Blutspiegeln zeigten, was möglicherweise die Notwendigkeit einer therapeutischen Medikamentenüberwachung (TDM) überflüssig macht. Dieser Fortschritt könnte über 43 Millionen Amerikaner mit Alzheimer, bipolarer Störung, Major Depression und PTBS zugutekommen.
Die Studie folgt auf die erfolgreiche Entwicklung einer neuartigen Kopfspule durch Tesla Dynamic Coils BV, die für die Durchführung der Studie entscheidend ist.
- Previous mouse studies showed AL001 achieves better brain absorption with lower blood lithium levels
- Potential elimination of therapeutic drug monitoring requirement could improve treatment accessibility
- Technology could benefit over 43 million Americans across multiple conditions
- Novel formulation may reduce kidney and thyroid side effects associated with traditional lithium therapies
- Results from Phase II trial still pending and success not guaranteed
- Study currently only involves healthy subjects, not actual patients with target conditions
- Commercial viability and regulatory approval timeline remain uncertain
Insights
Alzamend's first Phase II patient dosing for AL001 marks significant progress in developing a potentially safer lithium treatment with better brain targeting.
Alzamend Neuro has reached a critical milestone with the dosing of its first patient in the Phase II "Lithium in Brain" study for AL001 at Massachusetts General Hospital. This head-to-head comparison against existing lithium carbonate treatments is designed to evaluate a fundamental pharmacokinetic question: can AL001 achieve higher brain concentrations while maintaining lower blood levels of lithium?
The scientific rationale here is compelling. Conventional lithium salts, while effective for bipolar disorder, face significant clinical limitations due to their narrow therapeutic window, requiring regular therapeutic drug monitoring (TDM) and multiple daily doses. This monitoring burden substantially restricts lithium's clinical utility despite its established efficacy.
AL001's preclinical mouse data suggests a potentially transformative pharmacokinetic profile - better brain absorption with lower systemic exposure. If replicated in humans, this could eliminate the need for burdensome TDM and reduce kidney and thyroid toxicities that limit current lithium use.
The study design using healthy volunteers is methodologically sound, establishing baseline pharmacokinetic parameters before moving to patient populations. The innovative head coil developed by Tesla Dynamic Coils BV likely enables more precise measurement of brain lithium concentrations.
With topline data expected by year-end 2025, this represents a critical value-driving catalyst. The company is pursuing multiple high-value indications including Alzheimer's, bipolar disorder, major depression, and PTSD - a potential combined patient population exceeding 43 million Americans.
If successful, AL001 could significantly expand lithium's clinical utility across neuropsychiatric conditions by addressing the primary limitations of current formulations - monitoring burden and toxicity profiles.
- 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 29, 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 dosing 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.
“The dosing of the first patient in our first Phase II trial of AL001 is another significant step forward in our goal to introduce a next-generation lithium treatment that offers enhanced safety, better central nervous system targeting, and eliminates the requirement for TDM,” stated Stephan Jackman, Chief Executive Officer of Alzamend. “This advancement stands to potentially enhance the lives of over 43 million Americans suffering from Alzheimer’s, BD, MDD and PTSD. We expect to announce topline data from this study before the end of 2025.”
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
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