Alzamend Neuro Initiates First Phase II Clinical Trial of AL001 “Lithium in Brain” Study Taking Place at Massachusetts General Hospital
Alzamend Neuro (NASDAQ: ALZN) has initiated its first of five Phase II clinical trials for AL001, a novel lithium-based treatment, at Massachusetts General Hospital. The study will compare AL001 with marketed lithium carbonate to evaluate brain and blood pharmacokinetics in healthy subjects, with topline data expected by year-end.
AL001 represents a potential breakthrough in lithium treatment, showing better brain absorption while maintaining lower blood levels in previous mouse studies. The drug aims to eliminate the need for therapeutic drug monitoring (TDM), addressing a major limitation of current lithium treatments. This advancement could benefit over 43 million Americans affected by Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD.
Alzamend Neuro (NASDAQ: ALZN) ha avviato il primo di cinque studi clinici di Fase II per AL001, un nuovo trattamento a base di litio, presso il Massachusetts General Hospital. Lo studio confronterà AL001 con il carbonato di litio già in commercio per valutare la farmacocinetica cerebrale e ematica in soggetti sani, con i dati preliminari attesi entro la fine dell'anno.
AL001 rappresenta un potenziale progresso nel trattamento con litio, mostrando una migliore assorbimento cerebrale mantenendo livelli ematici più bassi in studi precedenti su topi. Il farmaco mira a eliminare la necessità del monitoraggio terapeutico del farmaco (TDM), superando un importante limite degli attuali trattamenti a base di litio. Questo progresso potrebbe beneficiare oltre 43 milioni di americani affetti da Alzheimer, disturbo bipolare, disturbo depressivo maggiore e PTSD.
Alzamend Neuro (NASDAQ: ALZN) ha iniciado su primer ensayo clínico de Fase II de cinco para AL001, un novedoso tratamiento a base de litio, en el Massachusetts General Hospital. El estudio comparará AL001 con el carbonato de litio comercializado para evaluar la farmacocinética cerebral y sanguínea en sujetos sanos, con datos principales esperados para fin de año.
AL001 representa un posible avance en el tratamiento con litio, mostrando mejor absorción cerebral mientras mantiene niveles sanguíneos más bajos en estudios previos con ratones. El medicamento busca eliminar la necesidad de monitoreo terapéutico del fármaco (TDM), abordando una limitación importante de los tratamientos actuales con litio. Este avance podría beneficiar a más de 43 millones de estadounidenses afectados por enfermedad de Alzheimer, trastorno bipolar, trastorno depresivo mayor y TEPT.
Alzamend Neuro (NASDAQ: ALZN)는 매사추세츠 종합병원에서 리튬 기반 신약 AL001의 5건 중 첫 번째 2상 임상시험을 시작했습니다. 본 연구는 건강한 피험자들을 대상으로 AL001과 시판 중인 탄산리튬의 뇌 및 혈중 약동학을 비교하며, 주요 데이터는 연말까지 발표될 예정입니다.
AL001은 이전 쥐 실험에서 혈중 농도를 낮게 유지하면서 뇌 흡수가 더 우수한 리튬 치료의 잠재적 혁신입니다. 이 약물은 치료 약물 모니터링(TDM)의 필요성을 없애 현재 리튬 치료의 주요 한계를 극복하는 것을 목표로 합니다. 이 진보는 알츠하이머병, 양극성 장애, 주요 우울장애, PTSD로 고통받는 4,300만 명 이상의 미국인들에게 도움이 될 수 있습니다.
Alzamend Neuro (NASDAQ : ALZN) a lancé son premier essai clinique de phase II sur cinq pour AL001, un nouveau traitement à base de lithium, au Massachusetts General Hospital. L'étude comparera AL001 au carbonate de lithium commercialisé afin d'évaluer la pharmacocinétique cérébrale et sanguine chez des sujets sains, avec des données principales attendues d'ici la fin de l'année.
AL001 représente une avancée potentielle dans le traitement au lithium, montrant une meilleure absorption cérébrale tout en maintenant des niveaux sanguins plus bas lors d'études précédentes chez la souris. Le médicament vise à éliminer le besoin de surveillance thérapeutique du médicament (TDM), répondant ainsi à une limite majeure des traitements actuels au lithium. Cette avancée pourrait bénéficier à plus de 43 millions d'Américains souffrant de maladie d'Alzheimer, trouble bipolaire, trouble dépressif majeur et SSPT.
Alzamend Neuro (NASDAQ: ALZN) hat seine erste von fünf Phase-II-Studien für AL001, eine neuartige lithiumbasierte Behandlung, am Massachusetts General Hospital gestartet. Die Studie wird AL001 mit handelsüblichem Lithiumcarbonat vergleichen, um die Pharmakokinetik im Gehirn und Blut bei gesunden Probanden zu bewerten. Die wichtigsten Ergebnisse werden bis Jahresende erwartet.
AL001 stellt einen potenziellen Durchbruch in der Lithiumtherapie dar, da es in früheren Mausstudien eine bessere Gehirnaufnahme bei gleichzeitig niedrigeren Blutspiegeln zeigte. Das Medikament zielt darauf ab, die Notwendigkeit der therapeutischen Arzneimittelüberwachung (TDM) zu beseitigen und damit eine wesentliche Einschränkung der aktuellen Lithiumbehandlungen zu überwinden. Dieser Fortschritt könnte über 43 Millionen Amerikanern zugutekommen, die an Alzheimer, bipolarer Störung, majorer Depression und PTBS leiden.
- Previous mouse studies demonstrated better brain absorption with lower blood levels of lithium for AL001
- Potential elimination of therapeutic drug monitoring requirement, improving treatment convenience
- Could reduce kidney and thyroid side effects associated with traditional lithium therapies
- Large market potential targeting 43 million Americans with various conditions
- Still in early Phase II stage with no efficacy data in humans yet
- Results from healthy subjects may not translate to patient populations
- Multiple Phase II studies required before advancing to Phase III
- Competition from existing lithium treatments in the market
Insights
Alzamend's Phase II trial of AL001 signals advancement in developing a potentially superior lithium delivery system with better brain targeting and fewer monitoring requirements.
This Phase II clinical trial initiation for AL001 marks a significant milestone in Alzamend's clinical development program. The company is testing a novel lithium formulation that could potentially overcome key limitations of current lithium treatments. The study design is particularly noteworthy for its head-to-head comparison with marketed lithium carbonate, specifically measuring lithium brain/brain-structure pharmacokinetics versus blood levels in healthy subjects.
The trial builds on promising preclinical data showing AL001 achieves better brain absorption while maintaining lower blood lithium levels - addressing one of the fundamental challenges with current lithium therapies. Standard lithium salts require stringent therapeutic drug monitoring (TDM) due to their narrow therapeutic window, creating significant treatment barriers.
What makes this approach innovative is AL001's potential to eliminate the need for TDM, which currently necessitates regular plasma monitoring and blood chemistry tests. This could dramatically improve treatment adherence and safety while reducing healthcare utilization costs.
The collaboration with Massachusetts General Hospital adds credibility to this program, while the novel head coil developed by Tesla Dynamic Coils BV will likely allow for precise measurement of brain lithium concentrations. With topline data expected before year-end, this study will provide critical pharmacokinetic data to guide the subsequent four Phase II trials targeting specific patient populations with Alzheimer's, bipolar disorder, depression, and PTSD.
If successful, AL001 could represent a paradigm shift in lithium therapy by offering enhanced safety, superior brain targeting, and eliminating the burdensome monitoring requirements that have limited lithium's clinical utility despite its established efficacy.
- 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 13, 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 initiation of the first of five Phase II clinical studies of AL001, with the first study 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.
“With AL001, we can potentially introduce a next-generation lithium treatment that offers enhanced safety, better brain targeting, and no need for TDM, promising a leap forward from the current, burdensome options,” 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 by providing a safer, more effective and user-friendly therapeutic option, potentially reshaping current treatment paradigms and improving patient quality of life substantially.”
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
FAQ
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