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 Alzheimer’s Disease
Alzamend Neuro (ALZN) has partnered with Massachusetts General Hospital for a Phase II clinical trial of AL001, a next-generation lithium therapeutic drug candidate for Alzheimer's disease. 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 the increase in lithium levels in the brain and its structures among Alzheimer's patients and healthy subjects.
The trial seeks to determine the minimum effective dose of AL001 that is safe and as effective as current products. Alzamend previously completed a Phase IIA trial, identifying a maximum tolerated dose of AL001. The company aims to develop a lithium product with an improved safety profile that doesn't require routine therapeutic drug monitoring, potentially benefiting the 6+ million Americans with Alzheimer's.
Alzamend Neuro (ALZN) ha collaborato con il Massachusetts General Hospital per un trial clinico di Fase II di AL001, un candidato terapeutico a base di litio di nuova generazione per il morbo di Alzheimer. Lo studio, guidato dal Professore Associato della Harvard University, Dr. Ovidiu Andronesi, ha l'obiettivo di confrontare AL001 con un prodotto commerciale a base di carbonato di litio. L'obiettivo è valutare l'aumento dei livelli di litio nel cervello e nelle sue strutture tra i pazienti affetti da Alzheimer e i soggetti sani.
Il trial mira a determinare la dose minima efficace di AL001 che sia sicura ed efficace come i prodotti attuali. Alzamend ha già completato un trial di Fase IIA, identificando una dose massima tollerata di AL001. L'azienda punta a sviluppare un prodotto a base di litio con un profilo di sicurezza migliorato che non richieda un monitoraggio terapeutico routinario, potenzialmente a beneficio dei 6+ milioni di americani affetti da Alzheimer.
Alzamend Neuro (ALZN) se ha asociado con el Massachusetts General Hospital para un ensayo clínico de Fase II de AL001, un candidato terapéutico de litio de nueva generación para la enfermedad de Alzheimer. 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 ya Comercializado. El objetivo es evaluar el aumento de los niveles de litio en el cerebro y sus estructuras entre los pacientes con Alzheimer y los sujetos sanos.
El ensayo busca determinar la dosis mínima efectiva de AL001 que sea segura y tan eficaz como los productos actuales. Alzamend ya completó un ensayo de Fase IIA, identificando una dosis máxima tolerada de AL001. La compañía pretende desarrollar un producto de litio con un perfil de seguridad mejorado que no requiera un monitoreo terapéutico rutinario, beneficiando potencialmente a los más de 6 millones de estadounidenses con Alzheimer.
Alzamend Neuro (ALZN)은 AL001이라는 차세대 리튬 치료제 후보에 대한 2상 임상 시험을 위해 매사추세츠 종합 병원과 협력했습니다. 이 연구는 하버드 대학교의 오비디우 안드로네시 부교수가 이끌며, AL001을 판매되고 있는 리튬 탄산염 제품과 비교하는 것을 목표로 하고 있습니다. 이 연구의 목적은 알츠하이머 환자와 건강한 피험자 사이에서 뇌와 그 구조의 리튬 수치 증가를 평가하는 것입니다.
이 시험은 AL001의 최소 유효 용량을 안전하게 결정하고 현재의 제품과 동일한 효과를 나타내는 것을 목표로 하고 있습니다. Alzamend는 이미 1상 A 시험을 완료하고 AL001의 최대 내약 용량을 확인했습니다. 이 회사는 정기적인 치료 약물 모니터링이 필요 없는 향상된 안전성 프로파일을 가진 리튬 제품을 개발하는 것을 목표로 하며, 이는 알츠하이머에 걸린 600만 명 이상의 미국인들에게 잠재적인 혜택을 줄 수 있습니다.
Alzamend Neuro (ALZN) s'est associé à l'hôpital général du Massachusetts pour un essai clinique de phase II de AL001, un candidat thérapeutique au lithium de nouvelle génération pour la maladie d'Alzheimer. L'étude, dirigée par le professeur associé de l'université de Harvard, Dr. Ovidiu Andronesi, vise à comparer AL001 avec un produit de carbonate de lithium déjà commercialisé. L'objectif est d'évaluer l'augmentation des niveaux de lithium dans le cerveau et ses structures chez les patients atteints d'Alzheimer et chez les sujets sains.
L'essai cherche à déterminer la dose minimale efficace de AL001 qui soit sûre et aussi efficace que les produits actuels. Alzamend a précédemment complété un essai de phase IIA, identifiant une dose maximale tolérée de AL001. L'entreprise vise à développer un produit au lithium avec un profil de sécurité amélioré qui ne nécessite pas de surveillance thérapeutique routinière, ce qui pourrait bénéficier aux plus de 6 millions d'Américains atteints d'Alzheimer.
Alzamend Neuro (ALZN) hat eine Partnerschaft mit dem Massachusetts General Hospital für eine Phase-II-Studie zu AL001, einem lithiumbasierten Therapeutikum der nächsten Generation gegen Alzheimer, geschlossen. Die Studie, die von Professor Dr. Ovidiu Andronesi, Associate Professor an der Harvard University, geleitet wird, hat zum Ziel, AL001 mit einem auf dem Markt befindlichen Lithiumcarbonatprodukt zu vergleichen. Ziel ist es, den Anstieg der Lithiumspiegel im Gehirn und dessen Strukturen bei Alzheimer-Patienten sowie bei gesunden Probanden zu bewerten.
Die Studie soll die minimal effektive Dosis von AL001 bestimmen, die sicher ist und eine ähnliche Wirksamkeit wie die aktuellen Produkte aufweist. Alzamend hat zuvor eine Phase-IIA-Studie abgeschlossen, bei der eine maximal tolerierte Dosis von AL001 identifiziert wurde. Das Unternehmen beabsichtigt, ein Lithiumprodukt mit einem verbesserten Sicherheitsprofil zu entwickeln, das keine routinemäßige Überwachung der therapeutischen Medikation erfordert, was potenziell den über 6 Millionen Amerikanern mit Alzheimer zugutekommen könnte.
- Partnership with prestigious Massachusetts General Hospital for Phase II clinical trial
- Successful completion of Phase IIA trial, identifying maximum tolerated dose of AL001
- Potential development of a safer lithium product without routine therapeutic drug monitoring
- Targeting a large market of 6+ million Americans with Alzheimer's disease
- AL001 still in early clinical stages, with no guarantee of success
- Potential regulatory hurdles in the FDA approval process
- Competition from existing lithium-based treatments in the market
This partnership between Alzamend Neuro and Massachusetts General Hospital for a Phase II clinical trial of AL001 is highly significant for Alzheimer's research. The study's focus on comparing AL001 with existing lithium carbonate products could potentially revolutionize Alzheimer's treatment.
Key points to consider:
- The involvement of Dr. Ovidiu Andronesi, a Harvard professor and expert in metabolic imaging, adds substantial credibility to the study.
- The novel approach of assessing lithium levels in the brain could lead to more precise dosing, potentially improving efficacy and reducing side effects.
- The 505(b)(2) pathway could expedite FDA approval if AL001 demonstrates superiority over existing lithium treatments.
- The previously established maximum tolerated dose (MTD) of AL001, equivalent to
240 mg of lithium carbonate 3 times daily, may eliminate the need for therapeutic drug monitoring, a significant advantage for patient management.
While promising, investors should note that Phase II trials still carry substantial risks and success is not guaranteed. However, positive results could significantly impact Alzamend's market position in the competitive Alzheimer's treatment landscape.
The development of AL001 as a next-generation lithium therapeutic for Alzheimer's disease is a noteworthy advancement in neuropharmacology. This study's design offers several potential advantages:
- Improved brain penetration: By comparing lithium levels in the brain and its structures, researchers may optimize AL001's formulation for better central nervous system targeting.
- Enhanced safety profile: The goal to achieve effectiveness at lower doses could reduce systemic side effects associated with traditional lithium treatments.
- Broader applicability: If successful, AL001 could be used in 'fragile populations' like Alzheimer's patients, expanding the therapeutic use of lithium beyond mood disorders.
The inclusion of both Alzheimer's patients and healthy subjects in the study will provide valuable comparative data on how the disease state affects drug pharmacokinetics. This comprehensive approach could lead to more personalized treatment strategies. However, it's important to remember that even if AL001 shows promise in this Phase II trial, further studies will be needed to fully establish its efficacy and long-term safety in Alzheimer's treatment.
- 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 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.
The objective of this novel trial is to assess the comparative increase in lithium levels within the brain and its structures as opposed to a commonly marketed lithium salt among Alzheimer’s patients and healthy subjects. By examining the lithium content in the brains and brain structures of patients during treatments, Alzamend aims to predict the minimum dose necessary to achieve the equivalent effectiveness and safety of AL001 in contrast to established lithium salts. Alzamend is optimistic that this study will assist in meeting the regulatory safety standards through the Section 505(b)(2) pathway for approval 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”). This MTD is risk mitigated for the purpose of treating fragile populations, such as Alzheimer’s patients.
“We are elated to partner with Mass General 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 6+ million Americans afflicted with Alzheimer’s. 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
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