Alzamend Neuro Announces Initiation Date of Phase II Clinical Trial of AL001 for Treatment of Post-Traumatic Stress Disorder to take Place at Massachusetts General Hospital
Alzamend Neuro (NASDAQ: ALZN) has announced plans to initiate a Phase II clinical study of AL001 for treating post-traumatic stress disorder (PTSD) in Q4 2025. The trial, to be conducted at Massachusetts General Hospital, will compare AL001 with marketed lithium carbonate to evaluate lithium blood and brain pharmacokinetics in PTSD subjects.
The study follows the successful completion of a head coil by Tesla Dynamic Coils BV. Previous mouse studies demonstrated AL001's superior brain absorption while maintaining lower blood lithium levels, potentially eliminating the need for therapeutic drug monitoring (TDM). While lithium lacks FDA approval for PTSD, case reports suggest effectiveness at low doses (300-600 mg/day) in reducing anger, irritability, anxiety, and insomnia in PTSD patients.
The development aims to overcome limitations of current FDA-approved lithium salts, which require regular monitoring due to a narrow therapeutic window. This advancement could benefit over 9 million Americans with PTSD by offering a more effective treatment option with enhanced safety and better brain targeting.
Alzamend Neuro (NASDAQ: ALZN) ha annunciato piani per avviare uno studio clinico di Fase II su AL001 per il trattamento del disturbo da stress post-traumatico (PTSD) nel quarto trimestre del 2025. La sperimentazione, che si svolgerà presso il Massachusetts General Hospital, confronterà AL001 con il carbonato di litio commercializzato per valutare la farmacocinetica del litio nel sangue e nel cervello nei soggetti con PTSD.
Lo studio segue il completamento con successo di una bobina per la testa da parte di Tesla Dynamic Coils BV. Studi precedenti su topi hanno dimostrato una migliore assorbimento cerebrale di AL001 mantenendo livelli di litio nel sangue più bassi, potenzialmente eliminando la necessità di monitoraggio terapeutico dei farmaci (TDM). Sebbene il litio non abbia l'approvazione della FDA per il PTSD, rapporti di casi suggeriscono l'efficacia a basse dosi (300-600 mg/giorno) nella riduzione della rabbia, irritabilità, ansia e insonnia nei pazienti con PTSD.
Lo sviluppo mira a superare le limitazioni dei sali di litio attualmente approvati dalla FDA, che richiedono un monitoraggio regolare a causa di una finestra terapeutica ristretta. Questo progresso potrebbe beneficiare oltre 9 milioni di americani con PTSD offrendo un'opzione di trattamento più efficace con una maggiore sicurezza e un miglior targeting cerebrale.
Alzamend Neuro (NASDAQ: ALZN) ha anunciado planes para iniciar un estudio clínico de Fase II de AL001 para tratar el trastorno de estrés postraumático (TEPT) en el cuarto trimestre de 2025. El ensayo, que se llevará a cabo en el Massachusetts General Hospital, comparará AL001 con carbonato de litio comercializado para evaluar la farmacocinética del litio en sangre y cerebro en sujetos con TEPT.
El estudio sigue a la exitosa finalización de una bobina para la cabeza por parte de Tesla Dynamic Coils BV. Estudios previos en ratones demostraron la superior absorción cerebral de AL001 mientras mantenía niveles más bajos de litio en sangre, lo que podría eliminar la necesidad de monitoreo terapéutico de medicamentos (TDM). Aunque el litio no tiene la aprobación de la FDA para el TEPT, los informes de casos sugieren efectividad a bajas dosis (300-600 mg/día) en la reducción de la ira, irritabilidad, ansiedad e insomnio en pacientes con TEPT.
El desarrollo busca superar las limitaciones de las sales de litio aprobadas por la FDA, que requieren monitoreo regular debido a una ventana terapéutica estrecha. Este avance podría beneficiar a más de 9 millones de estadounidenses con TEPT al ofrecer una opción de tratamiento más efectiva con mayor seguridad y mejor focalización cerebral.
Alzamend Neuro (NASDAQ: ALZN)는 2025년 4분기에 PTSD(외상 후 스트레스 장애) 치료를 위한 AL001의 2상 임상 연구를 시작할 계획을 발표했습니다. 이 시험은 매사추세츠 종합병원에서 진행되며, PTSD 환자에서 AL001과 상용화된 탄산리튬을 비교하여 리튬의 혈액 및 뇌 약리학적 작용을 평가할 것입니다.
이 연구는 Tesla Dynamic Coils BV가 헤드 코일을 성공적으로 완성한 후 진행됩니다. 이전 쥐 연구에서는 AL001의 우수한 뇌 흡수 능력이 입증되었으며, 혈중 리튬 수치는 낮은 수준을 유지하여 치료 약물 모니터링(TDM)의 필요성을 없앨 수 있습니다. 리튬은 PTSD에 대한 FDA 승인이 없지만, 사례 보고서에서는 PTSD 환자의 분노, 과민성, 불안 및 불면증을 줄이는 데 저용량(300-600 mg/일)에서 효과적이라는 것을 시사합니다.
이 개발은 정기적인 모니터링이 필요한 FDA 승인 리튬 염의 한계를 극복하는 것을 목표로 하고 있습니다. 이 발전은 900만 명 이상의 PTSD 환자에게 더 안전하고 효과적인 치료 옵션을 제공하여 혜택을 줄 수 있습니다.
Alzamend Neuro (NASDAQ: ALZN) a annoncé des plans pour initier une étude clinique de phase II sur AL001 pour traiter le trouble de stress post-traumatique (TSPT) au quatrième trimestre 2025. L'essai, qui sera réalisé au Massachusetts General Hospital, comparera AL001 avec du carbonate de lithium commercialisé pour évaluer la pharmacocinétique du lithium dans le sang et le cerveau chez des sujets atteints de TSPT.
L'étude 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 que AL001 avait une absorption cérébrale supérieure tout en maintenant des niveaux de lithium sanguin plus bas, ce qui pourrait éliminer le besoin de surveillance thérapeutique des médicaments (TDM). Bien que le lithium n'ait pas l'approbation de la FDA pour le TSPT, des rapports de cas suggèrent son efficacité à faibles doses (300-600 mg/jour) pour réduire la colère, l'irritabilité, l'anxiété et l'insomnie chez les patients atteints de TSPT.
Le développement vise à surmonter les limitations des sels de lithium actuellement approuvés par la FDA, qui nécessitent une surveillance régulière en raison d'une fenêtre thérapeutique étroite. Cette avancée pourrait bénéficier à plus de 9 millions d'Américains souffrant de TSPT en offrant une option de traitement plus efficace avec une sécurité accrue et un meilleur ciblage cérébral.
Alzamend Neuro (NASDAQ: ALZN) hat Pläne angekündigt, im vierten Quartal 2025 eine Phase-II-Studie zu AL001 zur Behandlung von posttraumatischer Belastungsstörung (PTBS) zu starten. Die Studie, die am Massachusetts General Hospital durchgeführt wird, wird AL001 mit vermarkteter Lithiumcarbonat vergleichen, um die Pharmakokinetik von Lithium im Blut und Gehirn bei PTBS-Patienten zu bewerten.
Die Studie folgt dem erfolgreichen Abschluss einer Kopfspule durch Tesla Dynamic Coils BV. Frühere Studien an Mäusen haben gezeigt, dass AL001 eine überlegene Gehirnaufnahme aufweist, während die Lithiumwerte im Blut niedriger bleiben, was möglicherweise die Notwendigkeit einer therapeutischen Arzneimittelüberwachung (TDM) ausschließt. Obwohl Lithium keine FDA-Zulassung für PTBS hat, deuten Fallberichte darauf hin, dass es in niedrigen Dosen (300-600 mg/Tag) wirksam ist, um Wut, Reizbarkeit, Angst und Schlaflosigkeit bei PTBS-Patienten zu reduzieren.
Die Entwicklung zielt darauf ab, die Einschränkungen der derzeit von der FDA zugelassenen Lithiumsalze zu überwinden, die aufgrund eines engen therapeutischen Fensters regelmäßige Überwachung erfordern. Dieser Fortschritt könnte über 9 Millionen Amerikanern mit PTBS zugutekommen, indem er eine effektivere Behandlungsoption mit verbesserter Sicherheit und besserer Gehirnausrichtung bietet.
- Phase II clinical trial initiation demonstrates progress in drug development pipeline
- Previous mouse studies showed superior brain absorption and lower blood lithium levels
- Potential elimination of therapeutic drug monitoring requirement
- Large market opportunity with over 9 million PTSD patients in the US
- Trial won't begin until Q4 2025, indicating a lengthy timeline to potential commercialization
- Lithium currently lacks FDA approval for PTSD treatment
- Competition from existing lithium treatments in the market
Insights
Alzamend Neuro's announcement represents a meaningful advancement in their clinical pipeline with plans to initiate a Phase II trial for AL001 in PTSD treatment. The most significant aspect is AL001's differentiated approach to lithium delivery - previous mouse studies suggest better brain penetration with lower systemic exposure compared to conventional lithium salts.
What makes this particularly interesting is the potential to eliminate therapeutic drug monitoring (TDM), a major limitation of current lithium treatments. Existing FDA-approved lithium formulations require regular blood tests due to their narrow therapeutic window, creating barriers to wider adoption despite proven efficacy in mood disorders.
However, investors should note several important contextual factors: 1) The trial won't begin until Q4 2025, placing any potential approval years away; 2) This remains a Phase II study - typically designed to assess efficacy signals rather than definitive proof; 3) While case reports suggest lithium's benefit in PTSD, it lacks FDA approval for this indication, representing an exploratory application.
The completion of the specialized head coil represents the current milestone enabling this future study, rather than any clinical data. The collaboration with Massachusetts General Hospital adds credibility to the research approach, potentially strengthening the trial design and execution.
This planned Phase II trial positions Alzamend to potentially address a significant unmet need in the PTSD treatment landscape. With over 9 million Americans suffering from PTSD and pharmaceutical options, a successful lithium-based therapy with improved safety and targeting could capture substantial market share.
The key innovation lies in AL001's pharmacokinetic profile. Current lithium treatments present a clinical conundrum - effective but burdened by narrow therapeutic windows requiring regular monitoring. AL001's potentially reduced systemic exposure while maintaining therapeutic brain levels could create a meaningful competitive advantage if proven in human studies.
From a market perspective, eliminating TDM requirements would remove a significant barrier to prescription and patient compliance. This represents both clinical and commercial value - simplified treatment protocols expand the potential prescriber base beyond specialists and improve patient experience.
The strategic partnership with Massachusetts General Hospital for this comparative study adds scientific credibility and increases the likelihood of generating robust, publishable data. However, the distant timeline (Q4 2025 start) means Alzamend faces a prolonged development runway before potential commercialization, requiring sufficient capital resources to reach clinical milestones.
This study's head-to-head design against existing lithium carbonate products demonstrates confidence in AL001's potential advantages and creates a clear differentiation pathway if successful.
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 PTSD subjects
ATLANTA, March 11, 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 PTSD in the fourth 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 PTSD 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 lithium salts (carbonate and citrate) approved by the U.S. Food and Drug Administration (“FDA”) 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. Although lithium does not have an FDA-approved indication for PTSD, case reports suggest that lithium treatment may be useful for treating PTSD patients. In particular, treatment with low doses (300–600 mg/day) of lithium carbonate have been reported to provide effective treatment in reduction of inappropriate anger, irritability, anxiety, and insomnia in those patients. The clinical observation of mood swings beyond the normal range, but milder than those associated with BD, reportedly suggested the presence of a sub-threshold mood disorder in these PTSD patients. It has also been proposed that treatment of trauma with lithium to forestall the development of PTSD may be provided by pharmacological induction of a mild transient amnesia.
“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 9 million Americans suffering from 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
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 PTSD treatment?
What advantages does AL001 offer over traditional lithium treatments for PTSD patients?
How many Americans could potentially benefit from ALZN's AL001 PTSD treatment?
What dosage of lithium carbonate has shown effectiveness in PTSD case reports?
