Alzamend Neuro Partners with Massachusetts General Hospital for a Phase II Clinical Trial of AL001, a Next‑Generation Lithium Therapeutic Drug Candidate, involving Patients with Bipolar Disorder
Alzamend Neuro (ALZN) has partnered with Massachusetts General Hospital for a Phase II clinical trial of AL001, a next-generation lithium therapeutic for bipolar disorder. The study, led by Harvard University Associate Professor Dr. Ovidiu Andronesi, aims to compare AL001 with a marketed lithium carbonate product. The objective is to assess lithium levels in the brain and its structures to identify an optimal dose of AL001 that is safe and effective.
AL001 is designed to provide lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily, potentially eliminating the need for therapeutic drug monitoring. This could be a significant improvement over current lithium-based treatments, which require regular monitoring due to a narrow therapeutic window. The study could help Alzamend meet FDA regulatory safety standards through the Section 505(b)(2) pathway.
Alzamend Neuro (ALZN) ha stretto una collaborazione con il Massachusetts General Hospital per un trial clinico di Fase II di AL001, una terapia a base di litio di nuova generazione per il disturbo bipolare. Lo studio, guidato dal Professore Associato della Harvard University, Dr. Ovidiu Andronesi, mira a confrontare AL001 con un prodotto di carbonato di litio già commercializzato. L'obiettivo è valutare i livelli di litio nel cervello e nelle sue strutture per identificare una dose ottimale di AL001 che sia sicura ed efficace.
AL001 è progettato per fornire litio a una dosi equivalente di carbonato di litio di 240 mg 3 volte al giorno, potenzialmente eliminando la necessità di monitoraggio terapeutico del farmaco. Questo potrebbe rappresentare un miglioramento significativo rispetto ai trattamenti attuali a base di litio, che richiedono un monitoraggio regolare a causa di una finestra terapeutica ristretta. Lo studio potrebbe aiutare Alzamend a soddisfare gli standard di sicurezza regolatori della FDA attraverso il percorso Sezione 505(b)(2).
Alzamend Neuro (ALZN) se ha asociado con el Massachusetts General Hospital para un ensayo clínico de Fase II de AL001, una terapia de litio de nueva generación para el trastorno bipolar. El estudio, dirigido por el Profesor Asociado de la Universidad de Harvard, Dr. Ovidiu Andronesi, tiene como objetivo comparar AL001 con un producto de carbonato de litio comercializado. El objetivo es evaluar los niveles de litio en el cerebro y sus estructuras para identificar una dosis óptima de AL001 que sea segura y efectiva.
AL001 está diseñado para proporcionar litio a una dosis equivalente de carbonato de litio de 240 mg 3 veces al día, lo que podría eliminar la necesidad de monitoreo terapéutico del fármaco. Esto podría representar una mejora significativa respecto a los tratamientos actuales a base de litio, que requieren un monitoreo regular debido a una ventana terapéutica estrecha. El estudio podría ayudar a Alzamend a cumplir con los estándares de seguridad regulatoria de la FDA a través del camino de la Sección 505(b)(2).
Alzamend Neuro (ALZN)은 매사추세츠 종합 병원과 협력하여 양극성 장애를 위한 차세대 리튬 치료제 AL001의 2상 임상 시험을 진행하고 있습니다. Harvard University의 부교수인 Ovidiu Andronesi 박사가 이끄는 이번 연구는 AL001을 시판 중인 리튬 탄산염 제품과 비교하는 것을 목표로 하고 있습니다. 목표는 뇌와 그 구조에서 리튬 수준을 평가하여 안전하고 효과적인 AL001의 최적 용량을 식별하는 것입니다.
AL001은 하루 3회 240mg 리튬 탄산염에 해당하는 용량을 제공하도록 설계되어 있어, 치료적 약물 모니터링의 필요성을 없앨 수 있습니다. 이는 좁은 치료 범위로 인해 정기적인 모니터링이 필요한 기존 리튬 기반 치료제에 비해 중대한 개선이 될 수 있습니다. 이번 연구는 Alzamend가 505(b)(2) 조항을 통해 FDA의 안전 규제를 충족하는 데 도움이 될 수 있습니다.
Alzamend Neuro (ALZN) s'est associé à Massachusetts General Hospital pour un essai clinique de Phase II d'AL001, une thérapie au lithium de nouvelle génération pour le trouble bipolaire. L'étude, dirigée par le professeur associé de l'Université de Harvard, Dr. Ovidiu Andronesi, vise à comparer AL001 à un produit de carbonate de lithium déjà commercialisé. L'objectif est d'évaluer les niveaux de lithium dans le cerveau et ses structures afin d'identifier une dose optimale d'AL001 qui soit sûre et efficace.
AL001 est conçu pour fournir du lithium à une d dose équivalente de carbonate de lithium de 240 mg 3 fois par jour, ce qui pourrait permettre d'éliminer la nécessité d'un suivi thérapeutique des médicaments. Cela pourrait représenter une amélioration significative par rapport aux traitements actuels à base de lithium, qui nécessitent un suivi régulier en raison d'une fenêtre thérapeutique étroite. L'étude pourrait aider Alzamend à répondre aux normes de sécurité réglementaires de la FDA par le biais du cheminement de l'Section 505(b)(2).
Alzamend Neuro (ALZN) hat sich mit dem Massachusetts General Hospital zusammengeschlossen, um eine Phase-II-Klinikstudie zu AL001, einem Lithiumtherapeutikum der nächsten Generation für bipolare Störung, durchzuführen. Die Studie, die von dem außerordentlichen Professor der Harvard-Universität, Dr. Ovidiu Andronesi, geleitet wird, hat zum Ziel, AL001 mit einem bereits vermarkteten Lithiumcarbonat-Produkt zu vergleichen. Ziel ist es, die Lithiumspiegel im Gehirn und in dessen Strukturen zu bewerten, um eine optimale, sichere und wirksame Dosis von AL001 zu identifizieren.
AL001 wurde entwickelt, um Lithium in einer Äquivalentdosis von 240 mg Lithiumcarbonat dreimal täglich bereitzustellen, was die Notwendigkeit einer therapeutischen Arzneimittelüberwachung möglicherweise überflüssig machen könnte. Dies könnte eine erhebliche Verbesserung gegenüber den derzeit auf Lithium basierenden Behandlungen darstellen, die aufgrund eines engen therapeutischen Fensters regelmäßige Überwachung erfordern. Die Studie könnte Alzamend helfen, die regulatorischen Sicherheitsstandards der FDA über den Abschnitt 505(b)(2) zu erfüllen.
- Partnership with prestigious Massachusetts General Hospital for Phase II clinical trial
- Potential to develop a lithium-based treatment without need for regular therapeutic drug monitoring
- Successful identification of maximum tolerated dose in previous Phase IIA trial
- Possible streamlined FDA approval process through Section 505(b)(2) pathway
- AL001 still in early clinical stages, with no guarantee of success or FDA approval
- Competitive market for bipolar disorder treatments
- Potential challenges in demonstrating superiority over existing lithium-based treatments
Insights
This partnership with Massachusetts General Hospital for a Phase II clinical trial of AL001 is a significant development for Alzamend Neuro. The study's focus on comparing brain lithium levels between AL001 and marketed lithium carbonate could provide crucial data for determining optimal dosing and efficacy.
The involvement of Dr. Ovidiu Andronesi, an expert in metabolic imaging, adds credibility to the study. If successful, AL001 could potentially offer a safer alternative to current lithium treatments for bipolar disorder, addressing issues like narrow therapeutic window and the need for frequent therapeutic drug monitoring.
However, investors should note that Phase II trials still carry significant risks and success is not guaranteed. The
This news is potentially positive for Alzamend Neuro's financial outlook. The partnership with a prestigious institution like Massachusetts General Hospital could enhance the company's credibility and attract investor interest. The focus on the 505(b)(2) pathway for FDA approval is strategically sound, as it may reduce development costs and time compared to traditional drug development processes.
However, it's important to note that Alzamend is still a clinical-stage company with no approved products. The success of AL001 is important for the company's future revenue potential. While the bipolar disorder market is substantial, the company will face competition from established treatments and other emerging therapies.
Investors should closely monitor the progress of this trial and any subsequent updates on the company's cash position and burn rate, as clinical trials are expensive endeavors for pre-revenue biotech companies.
- Harvard University Associate Professor, Dr. Ovidiu Andronesi MD, PhD, will be the principal investigator of the study
- Head-to-head study of AL001 versus a marketed lithium carbonate product will be conducted; the goal is to compare lithium in human brain and brain structures to identify a potentially ideal dose of AL001 that is safe and effective as current products
Alzamend and Mass General have contracted with Dr. Ovidiu Andronesi, MD, PhD, to be the principal investigator on the study. Dr. Andronesi is an Associate Professor of Radiology at Harvard University and the Director of Multinuclear Metabolic Imaging, Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School.
Lithium was the first mood stabilizer approved by the
Alzamend previously completed a Phase IIA multiple ascending dose clinical trial, in which it successfully identified a maximum tolerated dose (“MTD”) for development of AL001, as assessed by an independent safety review committee. This dose, providing lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily, is designed to be unlikely to require lithium therapeutic drug monitoring (“TDM”). Current FDA-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. Existing lithium drugs suffer from chronic toxicity, poor physicochemical properties, and poor brain bioavailability. However, because lithium is so effective at reducing manic episodes in patients with BD, it is still used clinically despite its narrow therapeutic index.
“We are elated to partner with Massachusetts General Hospital and Dr. Andronesi in this pivotal study for our lead therapeutic candidate AL001,” said Stephan Jackman, Chief Executive Officer of Alzamend. “If we can develop a next-generation lithium product (AL001) with an improved safety profile and enhanced biodistribution in the brain that would not routinely require TDM, it would constitute a major improvement over current lithium-based treatments and positively impact the 7+ million Americans afflicted with BD. We look forward to providing more details regarding the study’s timeline and market opportunity in the near future.”
About AL001
AL001 is a novel lithium-delivery system that has the potential to deliver 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 an 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
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Email: Info@Alzamend.com or call: 1-844-722-6333
Source: Alzamend Neuro, Inc.
FAQ
What is the purpose of Alzamend Neuro's Phase II clinical trial for AL001?
Who is leading the Phase II clinical trial for Alzamend Neuro's AL001?
What advantage does AL001 (ALZN) potentially offer over current lithium-based treatments?
What was the outcome of Alzamend Neuro's previous Phase IIA trial for AL001?
