Alzamend Neuro, Inc. (NASDAQ:ALZN) on Wednesday announced the completion of the clinical portion of its first Phase 2 clinical study of AL001 in healthy human subjects.
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Topline data is expected in the first quarter of 2026. Earlier, the company expected topline results from the first trial by year-end 2025, with follow-up trials in bipolar disorder, major depressive disorder, post-traumatic stress disorder, and Alzheimer's launching through early 2026.
AL001
In collaboration with Massachusetts General Hospital as the clinical trial site, Alzamend is investigating the distinctive characteristics of AL001.
Alzamend Neuro AL001 (LiProSal) is a novel, patented oral therapeutic drug candidate for the treatment of Alzheimer's disease, bipolar disorder (BD), major depressive disorder (MDD), and post-traumatic stress disorder (PTSD). It is designed as a safer and more effective lithium-delivery system compared to traditional lithium salts.
The primary objective is to assess how AL001 delivers lithium to the brain compared to marketed lithium salts, evaluating its ability to achieve better therapeutic efficacy while minimizing systemic side effects.
The clinical study utilized an engineered head coil developed by Tesla Dynamic Coils BV, which grants the capability for high-resolution, whole-brain lithium imaging, which allows for the precise quantification of lithium within specific brain structures.
The resulting proprietary imaging data sets will be used to establish a foundational reference, helping Alzamend accurately identify the optimal, disease-specific target doses of AL001.
By potentially removing the requirement for lithium therapeutic drug monitoring, AL001 could transform treatment for at-risk patient groups and enhance clinical outcomes.
Lithium is widely recognized as a highly effective first-line option for managing manic episodes and maintenance in BD, yet TDM challenges have limited its adoption.
Lithium salts approved by the U.S. Food and Drug Administration currently face a narrow therapeutic index, necessitating frequent clinician-monitored plasma lithium and blood chemistry tests to prevent adverse effects.
Through reduced systemic exposure, Alzamend's AL001 formulation may represent a paradigm shift in treating disorders such as Alzheimer's, by lowering the risks of kidney and thyroid complications commonly associated with conventional lithium regimens.
ALZN002
The company's secondary therapeutic drug candidate, ALZN002, is a proprietary "active" immunotherapy product, which means it is produced by the patient's immune system.
ALZN002 uses autologous dendritic cells engineered to target amyloid-beta proteins, aiming for safe, long-lasting reduction of beta-amyloid plaques—unlike antibody-based approaches that rely on foreign products.
In April 2023, Alzamend Neuro initiated a Phase 1/2A trial for ALZN002 to evaluate its safety, tolerability, and efficacy in 20-30 patients with mild to moderate Alzheimer's, comparing multiple ascending doses to a placebo.
ALZN Price Action: Alzamend Neuro shares were up 7.79% at $2.63 during premarket trading on Tuesday, according to Benzinga Pro data.
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