Alzamend Neuro Announces Initiation Date of Phase II Clinical Trial of AL001 for Treatment of Bipolar Disorder to take Place at Massachusetts General Hospital
Alzamend Neuro (NASDAQ: ALZN) has announced plans to initiate a Phase II clinical trial for AL001 in treating Bipolar Disorder (BD) in Q3 2025. The study, to be conducted at Massachusetts General Hospital, will compare AL001 with marketed lithium carbonate, focusing on lithium blood and brain pharmacokinetics.
The trial follows the successful completion of a head coil by Tesla Dynamic Coils BV. Previous mouse studies showed AL001 achieves better brain absorption while maintaining lower blood lithium levels. The novel formulation aims to eliminate the need for lithium therapeutic drug monitoring (TDM), addressing limitations of current FDA-approved lithium salts that require regular monitoring due to narrow therapeutic windows.
AL001's potential advantages include enhanced safety, improved brain targeting, and reduced systemic side effects, particularly regarding kidney and thyroid complications commonly associated with traditional lithium therapies. This advancement could benefit over 7 million Americans with BD by offering a more effective treatment option.
Alzamend Neuro (NASDAQ: ALZN) ha annunciato piani per avviare uno studio clinico di Fase II per AL001 nel trattamento del Disturbo Bipolare (DB) nel terzo trimestre del 2025. Lo studio, che sarà condotto presso il Massachusetts General Hospital, confronterà AL001 con il carbonato di litio commercializzato, concentrandosi sulla farmacocinetica del litio nel sangue e nel cervello.
Il trial segue il completamento con successo di una bobina per testa da parte di Tesla Dynamic Coils BV. Studi precedenti su topi hanno mostrato che AL001 raggiunge una migliore assorbimento cerebrale mantenendo livelli di litio nel sangue più bassi. La nuova formulazione mira a eliminare la necessità di monitoraggio terapeutico del farmaco al litio (TDM), affrontando le limitazioni dei sali di litio approvati dalla FDA che richiedono un monitoraggio regolare a causa delle strette finestre terapeutiche.
I potenziali vantaggi di AL001 includono una maggiore sicurezza, un miglior targeting cerebrale e una riduzione degli effetti collaterali sistemici, in particolare riguardo alle complicazioni renali e tiroidee comunemente associate alle terapie tradizionali a base di litio. Questo progresso potrebbe beneficiare oltre 7 milioni di americani con DB offrendo un'opzione terapeutica più efficace.
Alzamend Neuro (NASDAQ: ALZN) ha anunciado planes para iniciar un ensayo clínico de Fase II para AL001 en el tratamiento del Trastorno Bipolar (TB) en el tercer trimestre de 2025. El estudio, que se llevará a cabo en el Massachusetts General Hospital, comparará AL001 con el carbonato de litio comercializado, centrándose en la farmacocinética del litio en sangre y cerebro.
El ensayo sigue la exitosa finalización de una bobina para la cabeza por parte de Tesla Dynamic Coils BV. Estudios previos en ratones mostraron que AL001 logra una mejor absorción cerebral mientras mantiene niveles más bajos de litio en sangre. La nueva formulación busca eliminar la necesidad de monitoreo terapéutico del fármaco de litio (TDM), abordando las limitaciones de las sales de litio aprobadas por la FDA que requieren monitoreo regular debido a sus estrechas ventanas terapéuticas.
Las posibles ventajas de AL001 incluyen mayor seguridad, mejor focalización cerebral y reducción de efectos secundarios sistémicos, especialmente en relación con las complicaciones renales y tiroideas comúnmente asociadas con las terapias tradicionales de litio. Este avance podría beneficiar a más de 7 millones de estadounidenses con TB al ofrecer una opción de tratamiento más efectiva.
Alzamend Neuro (NASDAQ: ALZN)는 2025년 3분기에 양극성 장애(BD) 치료를 위한 AL001의 2상 임상 시험을 시작할 계획을 발표했습니다. 이 연구는 매사추세츠 종합 병원에서 진행되며, AL001과 시판 중인 탄산리튬을 비교하고 리튬의 혈중 및 뇌 내 약리학적 동태에 초점을 맞출 것입니다.
이번 시험은 Tesla Dynamic Coils BV의 헤드 코일 성공적 완료에 이어 진행됩니다. 이전 쥐 연구에서는 AL001이 더 낮은 혈중 리튬 수치를 유지하면서 더 나은 뇌 흡수를 달성한다는 결과가 나왔습니다. 이 새로운 제형은 리튬 치료 약물 모니터링(TDM)의 필요성을 없애는 것을 목표로 하며, 정기적인 모니터링이 필요한 기존 FDA 승인 리튬 염의 한계를 해결합니다.
AL001의 잠재적 이점으로는 향상된 안전성, 개선된 뇌 타겟팅, 그리고 전통적인 리튬 치료와 일반적으로 관련된 신장 및 갑상선 합병증에 대한 전신 부작용 감소가 포함됩니다. 이 진전은 BD를 앓고 있는 700만 명 이상의 미국인에게 보다 효과적인 치료 옵션을 제공함으로써 혜택을 줄 수 있습니다.
Alzamend Neuro (NASDAQ: ALZN) a annoncé des plans pour initier un essai clinique de Phase II pour AL001 dans le traitement du trouble bipolaire (TB) au troisième trimestre 2025. L'étude, qui sera réalisée au Massachusetts General Hospital, comparera AL001 avec le carbonate de lithium commercialisé, en se concentrant sur la pharmacocinétique du lithium dans le sang et dans le cerveau.
L'essai fait suite à l'achèvement réussi d'une bobine pour la tête par Tesla Dynamic Coils BV. Des études antérieures sur des souris ont montré qu'AL001 atteint une meilleure absorption cérébrale tout en maintenant des niveaux de lithium sanguin plus bas. La nouvelle formulation vise à éliminer la nécessité de surveillance thérapeutique des médicaments au lithium (TDM), en abordant les limitations des sels de lithium actuellement approuvés par la FDA, qui nécessitent une surveillance régulière en raison de fenêtres thérapeutiques étroites.
Les avantages potentiels d'AL001 incluent une sécurité accrue, un meilleur ciblage cérébral et une réduction des effets secondaires systémiques, en particulier en ce qui concerne les complications rénales et thyroïdiennes couramment associées aux thérapies traditionnelles au lithium. Cette avancée pourrait bénéficier à plus de 7 millions d'Américains atteints de TB en offrant une option de traitement plus efficace.
Alzamend Neuro (NASDAQ: ALZN) hat Pläne angekündigt, eine Phase-II-Studie für AL001 zur Behandlung von Bipolarer Störung (BD) im dritten Quartal 2025 zu starten. Die Studie, die am Massachusetts General Hospital durchgeführt wird, wird AL001 mit dem vermarkteten Lithiumcarbonat vergleichen und sich auf die Pharmakokinetik von Lithium im Blut und im Gehirn konzentrieren.
Die Studie folgt dem erfolgreichen Abschluss einer Kopfspule durch Tesla Dynamic Coils BV. Frühere Studien an Mäusen zeigten, dass AL001 eine bessere Gehirnaufnahme erreicht, während niedrigere Lithiumspiegel im Blut aufrechterhalten werden. Die neuartige Formulierung zielt darauf ab, die Notwendigkeit der Überwachung von Lithiumtherapeutika (TDM) zu beseitigen und die Einschränkungen der derzeit von der FDA genehmigten Lithiumsalze zu adressieren, die aufgrund enger therapeutischer Fenster regelmäßige Überwachung erfordern.
Die potenziellen Vorteile von AL001 umfassen verbesserte Sicherheit, bessere Zielgenauigkeit im Gehirn und reduzierte systemische Nebenwirkungen, insbesondere in Bezug auf Nieren- und Schilddrüsenkomplikationen, die häufig mit traditionellen Lithiumtherapien verbunden sind. Dieser Fortschritt könnte über 7 Millionen Amerikanern mit BD zugutekommen, indem er eine effektivere Behandlungsoption bietet.
- Phase II trial initiation represents significant clinical progress
- AL001 shows superior brain absorption in mouse studies
- Potential elimination of therapeutic drug monitoring requirement
- Large market opportunity with 7M+ American BD patients
- Phase II results not expected until after Q3 2025
- No human efficacy data available yet
- Competition from established lithium treatments
Insights
Alzamend Neuro's announcement represents a significant advancement in their clinical pipeline with the upcoming Phase II trial for AL001 in bipolar disorder. The trial, scheduled to begin in Q3 2025 at Massachusetts General Hospital, follows the successful development of specialized equipment needed for the study.
What makes this development particularly noteworthy is AL001's potentially differentiated mechanism compared to current lithium treatments. Preclinical data in mice suggests AL001 achieves better brain absorption while maintaining lower blood lithium levels - a critical improvement that could address the fundamental limitations of existing lithium therapies.
The current lithium treatment landscape is constrained by a narrow therapeutic window requiring vigilant monitoring. AL001 potentially eliminates the need for therapeutic drug monitoring (TDM), which represents a meaningful clinical advancement for the 7+ million Americans suffering from bipolar disorder.
This trial specifically aims to compare AL001 versus marketed lithium carbonate through head-to-head pharmacokinetic studies examining lithium distribution in blood and brain tissues. Success here would position Alzamend to potentially revolutionize bipolar disorder treatment by addressing the key drawbacks of current lithium therapies - systemic toxicity, narrow therapeutic window, and burdensome monitoring requirements.
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 Bipolar Disorder subjects
ATLANTA, March 04, 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 its plans to initiate a highly anticipated phase II clinical study of AL001 for treatment of patients with BD, which is expected to commence in the third quarter of 2025. This study follows the successful completion of a head coil by Tesla Dynamic Coils BV, a key component of the clinical trial.
In collaboration with Massachusetts General Hospital as its contract research organization, Alzamend aims to explore the unique properties of AL001 and its effects on lithium delivery in the brain compared to marketed lithium salts. The study could illuminate the path forward in patients with BD 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 (carbonate and citrate) 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 BD, 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 7 million Americans suffering from BD by providing a 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
Photos accompanying this announcement are available at
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FAQ
When will Alzamend Neuro (ALZN) begin its Phase II clinical trial for AL001 in Bipolar Disorder?
What are the key advantages of ALZN's AL001 compared to traditional lithium treatments?
How many patients could potentially benefit from ALZN's AL001 treatment?
What were the results of previous AL001 studies by ALZN?
