Alzamend Neuro Announces Full Data Set from its Nonclinical Study: Comparing Brain and Plasma Lithium Exposures between AL001 and Lithium Carbonate in Alzheimer’s Transgenic Mice
Alzamend Neuro (NASDAQ: ALZN) has completed analyzing data from a nonclinical study comparing AL001, their novel lithium formulation, with lithium carbonate in Alzheimer's transgenic mice. The study, conducted at the University of South Florida, revealed that AL001 achieved higher brain lithium concentrations while maintaining lower plasma levels compared to lithium carbonate, particularly at lower doses. The results showed no adverse effects, suggesting enhanced safety and efficacy potential for treating Alzheimer's, bipolar disorder, major depressive disorder, and PTSD. The company plans to proceed with five Phase II 'Lithium in Brain' clinical trials in partnership with Massachusetts General Hospital.
Alzamend Neuro (NASDAQ: ALZN) ha completato l'analisi dei dati di uno studio non clinico che confronta AL001, la loro nuova formulazione di litio, con il carbonato di litio in topi transgenici affetti da Alzheimer. Lo studio, condotto presso l'Università della Florida meridionale, ha rivelato che AL001 ha raggiunto concentrazioni di litio nel cervello superiori, mantenendo al contempo livelli plasmatici più bassi rispetto al carbonato di litio, in particolare a dosi inferiori. I risultati non hanno mostrato effetti avversi, suggerendo un potenziale miglioramento della sicurezza e dell'efficacia nel trattamento dell'Alzheimer, del disturbo bipolare, del disturbo depressivo maggiore e del PTSD. L'azienda prevede di proseguire con cinque trial clinici di Fase II 'Litio nel cervello' in collaborazione con il Massachusetts General Hospital.
Alzamend Neuro (NASDAQ: ALZN) ha completado el análisis de datos de un estudio no clínico que compara AL001, su nueva formulación de litio, con carbonato de litio en ratones transgénicos con Alzheimer. El estudio, llevado a cabo en la Universidad del Sur de Florida, reveló que AL001 logró concentraciones más altas de litio en el cerebro mientras mantenía niveles plasmáticos más bajos en comparación con el carbonato de litio, especialmente a dosis más bajas. Los resultados no mostraron efectos adversos, sugiriendo un potencial mejorado de seguridad y eficacia para tratar el Alzheimer, el trastorno bipolar, el trastorno depresivo mayor y el PTSD. La empresa planea proceder con cinco ensayos clínicos de Fase II 'Litio en el cerebro' en asociación con el Massachusetts General Hospital.
Alzamend Neuro (NASDAQ: ALZN)는 알츠하이머 유전자 변형 쥐에서 AL001, 그들의 새로운 리튬 제형,과 리튬 탄산염을 비교한 비임상 연구 결과를 분석 완료했습니다. 플로리다 남부 대학교에서 수행된 이 연구는 AL001이 리튬 탄산염과 비교하여 더 낮은 혈장 수준을 유지하면서 더 높은 뇌 리튬 농도를 달성했다는 것을 밝혔습니다, 특히 낮은 용량에서요. 결과는 부작용을 보이지 않았으며 알츠하이머, 양극성 장애, 주요 우울 장애 및 PTSD 치료에 대한 안전성과 효능 가능성을 향상시킬 수 있음을 제안하고 있습니다. 회사는 매사추세츠 종합병원과 협력하여 '뇌의 리튬'이라는 제목의 2상 임상 시험을 다섯 건 진행할 계획입니다.
Alzamend Neuro (NASDAQ: ALZN) a terminé d'analyser les données d'une étude non clinique comparant AL001, leur nouvelle formulation de lithium, au carbonate de lithium chez des souris transgéniques atteintes d'Alzheimer. L'étude, réalisée à l'Université de Floride du Sud, a révélé que AL001 a atteint des concentrations de lithium plus élevées dans le cerveau tout en maintenant des niveaux plasmatiques plus bas par rapport au carbonate de lithium, en particulier à des doses plus faibles. Les résultats n'ont montré aucun effet indésirable, suggérant un potentiel de sécurité et d'efficacité amélioré pour le traitement de l'Alzheimer, du trouble bipolaire, du trouble dépressif majeur et du PTSD. L'entreprise prévoit de procéder à cinq essais cliniques de phase II 'Lithium dans le cerveau' en partenariat avec le Massachusetts General Hospital.
Alzamend Neuro (NASDAQ: ALZN) hat die Analyse von Daten einer nicht klinischen Studie abgeschlossen, die AL001, ihre neuartige Lithium-Formulierung, mit Lithiumcarbonat bei transgenen Mäusen mit Alzheimer vergleicht. Die Studie, die an der Universität von Südflorida durchgeführt wurde, zeigte, dass AL001 höhere Lithiumkonzentrationen im Gehirn erreichte, während niedrigere Plasmaspiegel aufrechterhalten wurden im Vergleich zu Lithiumcarbonat, insbesondere in niedrigen Dosen. Die Ergebnisse zeigten keine unerwünschten Wirkungen und deuteten auf ein verbessertes Sicherheits- und Wirksamkeitspotenzial zur Behandlung von Alzheimer, bipolaren Störungen, majorer Depression und PTSD hin. Das Unternehmen plant, in Zusammenarbeit mit dem Massachusetts General Hospital fünf klinische Phase-II-Studien namens 'Lithium im Gehirn' durchzuführen.
- AL001 demonstrated higher brain lithium concentrations than lithium carbonate at lower doses
- Lower plasma lithium levels indicate reduced risk of systemic side effects
- No adverse effects observed during treatment period
- Results support advancement to multiple Phase II clinical trials
- Study to preclinical animal testing phase
- Clinical efficacy in humans yet to be demonstrated
- Multiple Phase II trials will require significant resources and time
Insights
This preclinical study demonstrates significant promise for AL001 as a potential improvement over traditional lithium carbonate. The key breakthrough lies in AL001's ability to achieve higher brain concentrations at lower doses while maintaining reduced plasma levels - a important advantage for safety and efficacy.
The data reveals two critical advantages: First, AL001's enhanced brain penetration suggests potential for better therapeutic outcomes at lower doses. Second, the reduced systemic exposure indicates a potentially better safety profile, particularly important for long-term use in conditions like Alzheimer's and bipolar disorder.
The upcoming five Phase II trials at Massachusetts General Hospital represent a major milestone, particularly given the positive preclinical results. The potential to eliminate routine blood lithium monitoring would be a significant advancement in patient care, especially for elderly populations.
This development positions ALZN strategically in the $43+ billion market spanning Alzheimer's, bipolar disorder, major depressive disorder and PTSD treatments. The potential for AL001 to address multiple high-value indications significantly expands its commercial opportunity.
The partnership with Massachusetts General Hospital adds substantial credibility and validation to the development program. If successful, AL001 could capture significant market share from existing lithium treatments, particularly given its improved safety profile and potential elimination of blood monitoring requirements - features that could drive both patient and physician preference.
- Alzamend is developing AL001, a lithium product designed for enhanced safety and efficacy compared to currently available FDA-approved and marketed lithium therapies
- At a low dose, AL001 evidenced consistently higher lithium concentrations than lithium carbonate within critical brain regions comprising target tissue for efficacy, which may provide therapeutic benefits with less risk in multiple neurological disorders
- Data will guide upcoming “Lithium in Brain” Phase II clinical trials in partnership with Massachusetts General Hospital
The study involved administering AL001, a good manufacturing practices-quality active pharmaceutical ingredient (“API”) to 5XFAD mice, a recognized model for Alzheimer’s research, to compare its effects against lithium carbonate, a
Key Findings:
- No Undue Adverse Effects: Both treatments had no negative impact on the mice's body weight or clinical signs during the treatment period.
- Reduced Systemic Exposure: AL001 showed lower plasma lithium levels than lithium carbonate, reducing the risk of adverse systemic effects, suggesting an expansion for safety of lithium’s therapeutic index.
- Enhanced Brain Penetration: AL001 showed consistently higher lithium concentrations in brain tissues, particularly at lower doses, compared to lithium carbonate.
- Targeted Brain Structures: The study found that different brain regions absorb and retain lithium differently. This means treatments can potentially be tailored to target specific brain areas, allowing for more precise treatment of various brain-related conditions when applied in human studies.
Clinical Implications:
These results highlight the potential clinical advantages of AL001 for conditions like Alzheimer’s, BD, MDD and PTSD at low doses. By reducing the systemic burden, AL001 could lessen the risk of side effects such as thyroid and kidney complications often associated with extant lithium therapies. This positions AL001 as a promising candidate for safer long-term treatment options, without the need for routine blood lithium monitoring. This innovation is specifically designed to address the needs of fragile populations, such as elderly and Alzheimer’s patients, by offering a potentially more efficient and safer alternative to existing treatments.
“This is a major step towards potentially providing an important treatment innovation for the 43+ million Americans afflicted with Alzheimer’s, BD, MDD and PTSD. These results demonstrated the potential of AL001 to enhance brain-specific lithium delivery while minimizing systemic exposure in an Alzheimer’s disease mouse model, guiding development of enhanced lithium effectiveness and safety in human diseases,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We appreciate the extraordinary efforts of our colleagues and partners. We look forward to further evaluating AL001 in five ‘Lithium in Brain’ Phase II clinical trials in healthy subjects and patients diagnosed with mild to moderate Alzheimer’s, BD, MDD and PTSD, in partnership with Massachusetts General Hospital at the dosing level observed to be appropriate in this nonclinical study.”
About Alzamend Neuro
Alzamend is an early 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 AL002 - a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic biologic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s. 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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