Alzamend Neuro Announces Completion of Clinical Portion of Phase II Clinical Trial of AL001 "Lithium in Brain" Study Conducted at Massachusetts General Hospital

Rhea-AI Summary

Alzamend Neuro (Nasdaq: ALZN) announced completion of the clinical portion of its Phase II study of AL001 in healthy subjects on Nov 19, 2025. The study compared lithium blood and brain pharmacokinetics of AL001 versus a marketed lithium carbonate product using a proprietary high-resolution whole-brain lithium imaging head coil from Tesla Dynamic Coils BV.

Topline data are expected in Q1 2026. Company says results will inform planned Phase II trials in Alzheimer's, bipolar disorder, major depressive disorder, and PTSD next year; prior mouse studies reportedly showed higher brain uptake with lower blood lithium levels.

Positive

• Completed clinical portion of Phase II study (healthy subjects)
• Topline data expected in Q1 2026
• Head-to-head brain and blood PK comparison versus marketed lithium carbonate
• Used unique high-resolution whole-brain lithium imaging head coil

Negative

• No topline clinical efficacy or safety results released yet
• Clinical advantage currently supported by prior mouse data only

Insights

Clinical development strategist

Completion of the Phase II clinical portion enables reporting of imaging-based lithium brain PK toplines in Q1 2026.

Alzamend completed the clinical portion of a Phase II study comparing AL001 to marketed lithium carbonate for brain and blood pharmacokinetics using a novel high‑resolution imaging coil. The study aims to show higher brain lithium delivery with lower systemic exposure, which would support a therapy that separates central efficacy from peripheral toxicity.

Key dependencies and risks include awaiting the blinded topline readout, translating prior mouse findings to humans, and demonstrating clinical benefit beyond PK differences. The proprietary imaging method and collaboration with the clinical site matter; any technical limits in quantifying regional brain lithium could alter interpretation.

Watch the topline PK and safety summaries due in Q1 2026, confirmation that lower blood levels coincide with robust brain uptake, and announcements about the planned Phase II trials expected next year. These items will determine whether the program advances as claimed and whether therapeutic drug monitoring may be avoidable.

• Topline data expected in first quarter of 2026
• Head-to-head studies of AL001 versus a marketed lithium carbonate product was conducted for comparisons of lithium blood and brain/brain-structure pharmacokinetics in healthy subjects

ATLANTA, Nov. 19, 2025 /PRNewswire/ -- 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 completion of the clinical portion of its first Phase II clinical study of AL001, in healthy human subjects.

In collaboration with Massachusetts General Hospital as the clinical trial site, Alzamend is investigating the distinctive characteristics of AL001. 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. This clinical study utilized a unique, engineered head coil developed by Tesla Dynamic Coils BV ("Tesla"). This one-of-a-kind technology 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. These findings will inform the planned Phase II clinical trials in Alzheimer's, BD, MDD, and PTSD, which are all expected to be initiated next year, and confirm that AL001 offers a superior balance of safety and efficacy compared to conventional lithium carbonate. Prior research in mice has demonstrated that AL001 achieves superior brain uptake while keeping blood lithium levels lower, setting the stage for safer and more effective therapies.

By potentially removing the requirement for lithium therapeutic drug monitoring ("TDM"), 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 its adoption has been limited by TDM challenges. 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 innovative 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.

"The completion of the clinical portion of our Phase II trial of AL001 marks a pivotal milestone in our mission to deliver a next-generation lithium therapy with improved safety, superior brain penetration, and no need for TDM," said Stephan Jackman, Chief Executive Officer of Alzamend. "We extend our heartfelt gratitude to the patients and investigators for their invaluable time and dedication to this study. Their contributions were essential to its successful completion. We look forward to reporting topline data in the first quarter of 2026 and further advancing clinical development of this promising potential therapeutic."

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/.

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SOURCE Alzamend Neuro, Inc.

FAQ

What did Alzamend (ALZN) announce on November 19, 2025 about AL001?

Alzamend announced completion of the clinical portion of its Phase II AL001 study and said topline data are expected in Q1 2026.

When will Alzamend (ALZN) release topline results from the AL001 Phase II study?

Topline data are expected in Q1 2026.

What comparisons were made in the AL001 study reported by Alzamend (ALZN)?

The study compared lithium blood and brain pharmacokinetics of AL001 versus a marketed lithium carbonate product in healthy subjects.

How did Alzamend (ALZN) measure lithium in the brain during the AL001 study?

The study used a proprietary, high-resolution whole-brain lithium imaging head coil developed by Tesla Dynamic Coils BV for precise brain-structure quantification.

Will AL001 Phase II findings lead to additional trials for Alzamend (ALZN)?

Alzamend said the findings will inform planned Phase II trials in Alzheimer's, bipolar disorder, MDD, and PTSD expected next year.

Do published AL001 results confirm clinical safety and efficacy for ALZN?

No; the company has not released topline clinical efficacy or safety results yet.