Alzamend Neuro Announces Initiation Date of First Phase II Clinical Trial of AL001 to take Place at Massachusetts General Hospital
Alzamend Neuro (NASDAQ: ALZN) has announced plans to initiate the first of five phase II clinical studies for AL001 in the second quarter of 2025. The initial study will be conducted at Massachusetts General Hospital with healthy human subjects following the successful development of a novel head coil by Tesla Dynamic Coils BV.
This head-to-head study will compare AL001 with marketed lithium carbonate products, focusing on lithium blood and brain pharmacokinetics. Previous mouse studies showed AL001 provides better brain absorption while maintaining lower blood lithium levels, potentially eliminating the need for therapeutic drug monitoring (TDM).
AL001 aims to overcome limitations of current FDA-approved lithium salts (carbonate and citrate), which require regular monitoring due to narrow therapeutic windows and multiple daily doses. The novel formulation could represent a significant advancement in treating Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD by reducing kidney and thyroid side effects associated with traditional lithium therapies.
Alzamend Neuro (NASDAQ: ALZN) ha annunciato piani per avviare il primo di cinque studi clinici di fase II per AL001 nel secondo trimestre del 2025. Lo studio iniziale sarà condotto presso Massachusetts General Hospital con soggetti umani sani, a seguito dello sviluppo riuscito di una nuova bobina per la testa da parte di Tesla Dynamic Coils BV.
Questo studio comparativo metterà a confronto AL001 con i prodotti commercializzati a base di carbonato di litio, concentrandosi sulla farmacocinetica del litio nel sangue e nel cervello. Studi precedenti sui topi hanno dimostrato che AL001 offre una migliore assorbimento cerebrale mantenendo livelli di litio nel sangue più bassi, potenzialmente eliminando la necessità di monitoraggio terapeutico dei farmaci (TDM).
AL001 mira a superare le limitazioni dei sali di litio attualmente approvati dalla FDA (carbonato e citrato), che richiedono un monitoraggio regolare a causa di finestre terapeutiche ristrette e di dosi multiple giornaliere. La nuova formulazione potrebbe rappresentare un significativo progresso nel trattamento di malattia di Alzheimer, disturbo bipolare, disturbo depressivo maggiore e PTSD, riducendo gli effetti collaterali renali e tiroidei associati alle terapie tradizionali a base di litio.
Alzamend Neuro (NASDAQ: ALZN) ha anunciado planes para iniciar el primero de cinco estudios clínicos de fase II para AL001 en el segundo trimestre de 2025. El estudio inicial se llevará a cabo en Massachusetts General Hospital con sujetos humanos sanos, tras el exitoso desarrollo de una nueva bobina para la cabeza por parte de Tesla Dynamic Coils BV.
Este estudio comparativo evaluará AL001 en comparación con productos comercializados de carbonato de litio, centrándose en la farmacocinética del litio en sangre y cerebro. Estudios previos en ratones mostraron que AL001 proporciona una mejor absorción cerebral mientras mantiene niveles de litio en sangre más bajos, lo que podría eliminar la necesidad de monitoreo terapéutico de medicamentos (TDM).
AL001 busca superar las limitaciones de las sales de litio actualmente aprobadas por la FDA (carbonato y citrato), que requieren un monitoreo regular debido a ventanas terapéuticas estrechas y múltiples dosis diarias. La nueva formulación podría representar un avance significativo en el tratamiento de la enfermedad de Alzheimer, el trastorno bipolar, el trastorno depresivo mayor y el PTSD, reduciendo los efectos secundarios renales y tiroideos asociados con las terapias tradicionales de litio.
Alzamend Neuro (NASDAQ: ALZN)는 AL001에 대한 5개의 2상 임상 연구 중 첫 번째를 2025년 2분기에 시작할 계획이라고 발표했습니다. 초기 연구는 매사추세츠 종합 병원에서 건강한 인간 대상자를 대상으로 수행될 예정이며, 이는 Tesla Dynamic Coils BV가 개발한 새로운 헤드 코일의 성공적인 결과에 따른 것입니다.
이 연구는 AL001과 시판 중인 탄산 리튬 제품을 비교하며, 리튬의 혈중 및 뇌 내 약물 동태에 초점을 맞출 것입니다. 이전 쥐 연구에서는 AL001이 더 낮은 혈중 리튬 수치를 유지하면서 더 나은 뇌 흡수를 제공하는 것으로 나타났으며, 이는 치료 약물 모니터링(TDM)의 필요성을 없앨 수 있습니다.
AL001은 현재 FDA 승인된 리튬 염(탄산염 및 구연산염)의 한계를 극복하는 것을 목표로 하며, 이는 좁은 치료 범위와 하루 여러 번의 복용으로 인해 정기적인 모니터링이 필요합니다. 이 새로운 제형은 알츠하이머병, 양극성 장애, 주요 우울 장애 및 PTSD 치료에 있어 전통적인 리튬 요법과 관련된 신장 및 갑상선 부작용을 줄임으로써 중요한 발전을 나타낼 수 있습니다.
Alzamend Neuro (NASDAQ: ALZN) a annoncé des projets pour initier la première de cinq études cliniques de phase II pour AL001 au deuxième trimestre de 2025. L'étude initiale sera menée à Massachusetts General Hospital avec des sujets humains en bonne santé, suite au développement réussi d'une nouvelle bobine pour la tête par Tesla Dynamic Coils BV.
Cette étude comparative mettra en regard AL001 avec des produits de carbonates de lithium commercialisés, en se concentrant sur la pharmacocinétique du lithium dans le sang et le cerveau. Des études antérieures sur des souris ont montré qu'AL001 offre une meilleure absorption cérébrale tout en maintenant des niveaux de lithium sanguin plus bas, ce qui pourrait éliminer la nécessité d'une surveillance thérapeutique des médicaments (TDM).
AL001 vise à surmonter les limitations des sels de lithium actuellement approuvés par la FDA (carbonate et citrate), qui nécessitent une surveillance régulière en raison de fenêtres thérapeutiques étroites et de doses multiples quotidiennes. La nouvelle formulation pourrait représenter une avancée significative dans le traitement de la maladie d'Alzheimer, des troubles bipolaires, des troubles dépressifs majeurs et du PTSD, en réduisant les effets secondaires rénaux et thyroïdiens associés aux thérapies traditionnelles au lithium.
Alzamend Neuro (NASDAQ: ALZN) hat Pläne angekündigt, im zweiten Quartal 2025 die erste von fünf klinischen Studien der Phase II für AL001 zu starten. Die erste Studie wird am Massachusetts General Hospital mit gesunden menschlichen Probanden durchgeführt, nachdem Tesla Dynamic Coils BV eine neuartige Kopfspule erfolgreich entwickelt hat.
Diese Vergleichsstudie wird AL001 mit auf dem Markt befindlichen Lithiumcarbonat-Produkten vergleichen und sich auf die Pharmakokinetik von Lithium im Blut und im Gehirn konzentrieren. Frühere Studien an Mäusen zeigten, dass AL001 eine bessere Gehirnaufnahme bietet, während die Lithiumspiegel im Blut niedriger bleiben, was möglicherweise die Notwendigkeit einer therapeutischen Arzneimittelüberwachung (TDM) überflüssig macht.
AL001 zielt darauf ab, die Einschränkungen der derzeit von der FDA zugelassenen Lithiumsalze (Carbonat und Citrate) zu überwinden, die aufgrund enger therapeutischer Fenster und mehrerer Tagesdosen regelmäßige Überwachung erfordern. Die neuartige Formulierung könnte einen bedeutenden Fortschritt bei der Behandlung von Alzheimer-Krankheit, bipolaren Störungen, schweren Depressionen und PTSD darstellen, indem sie die mit traditionellen Lithiumtherapien verbundenen Nieren- und Schilddrüsennebenwirkungen verringert.
- First of five phase II clinical trials for AL001 to begin in Q2 2025
- AL001 showed better brain absorption with lower blood lithium levels in previous mouse studies
- AL001 could potentially eliminate the need for lithium therapeutic drug monitoring
- The novel formulation may reduce kidney and thyroid side effects associated with traditional lithium therapies
- Clinical trials are still in early stages with results pending
- No data yet on AL001's efficacy in actual patients with Alzheimer's, bipolar disorder, MDD or PTSD
Insights
Alzamend Neuro's announcement of its first Phase II clinical trial for AL001 represents a pivotal development for this micro-cap biotech company. The trial, commencing in Q2 2025 at Massachusetts General Hospital, will evaluate AL001's novel lithium delivery system against traditional lithium carbonate in healthy subjects—establishing critical pharmacokinetic benchmarks before potential expansion into multiple high-value neuropsychiatric indications.
The development of the specialized head coil by Tesla Dynamic Coils BV is more significant than it might initially appear. This custom imaging technology will likely enable precise quantification of lithium concentrations in specific brain regions, potentially demonstrating AL001's improved blood-brain barrier penetration while maintaining lower systemic exposure—a key differentiator from conventional lithium therapies that require narrow therapeutic drug monitoring.
What's particularly compelling about AL001's approach is its potential to address the fundamental limitations that have restricted lithium's widespread use despite its established efficacy. Traditional lithium therapies require regular blood monitoring due to their narrow therapeutic window, creating substantial treatment barriers. If AL001 can deliver therapeutic concentrations to the brain while reducing systemic exposure, it could eliminate the need for therapeutic drug monitoring—potentially transforming treatment paradigms across multiple indications.
For investors, this progress must be contextualized within ALZN's broader financial position. With a market cap of approximately
The market opportunity across Alzheimer's, bipolar disorder, MDD, and PTSD is undeniably massive, with over 43 million affected Americans. However, the competitive landscape in CNS drug development is intensely challenging, with numerous failures even in late-stage trials. AL001's differentiated approach to an established mechanism (lithium) potentially offers a de-risked development pathway compared to novel molecular entities, though clinical validation remains the critical hurdle.
This Phase II program represents the most significant value-driving catalyst for ALZN in the near term. Positive data demonstrating AL001's improved brain targeting with reduced systemic exposure could substantially revalue the company, particularly if it supports the elimination of therapeutic drug monitoring requirements across multiple indications. Investors should closely monitor enrollment progress and interim results as key indicators of development momentum.
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 human subjects
ATLANTA, Feb. 25, 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 the first of five highly anticipated phase II clinical studies of AL001, with the first study, in healthy human subjects, expected to commence in the second quarter of 2025. 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 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 in healthy human subjects will serve as a baseline and could illuminate the 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 (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 Alzheimer’s disease, 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 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
When will Alzamend Neuro (ALZN) begin its first Phase II clinical trial for AL001?
What advantages does ALZN's AL001 have over traditional lithium treatments?
How many Phase II clinical studies is Alzamend Neuro (ALZN) planning for AL001?
What conditions is Alzamend Neuro (ALZN) targeting with its AL001 treatment?
What is the significance of the novel head coil developed by Tesla Dynamic Coils BV for ALZN's clinical trials?
Why is therapeutic drug monitoring (TDM) an issue with current lithium treatments that ALZN's AL001 aims to solve?
