Alzamend Neuro Announces Initiation Date of Phase II Clinical Trial of AL001 for Treatment of Major Depressive Disorder to take Place at Massachusetts General Hospital

Rhea-AI Summary

Alzamend Neuro (NASDAQ: ALZN) has announced plans to initiate a Phase II clinical trial of AL001 for Major Depressive Disorder (MDD) treatment in Q4 2025 at Massachusetts General Hospital. The study follows the successful completion of a head coil by Tesla Dynamic Coils BV.

The trial will compare AL001 with marketed lithium carbonate, focusing on lithium blood and brain pharmacokinetics in MDD patients. Previous mouse studies showed AL001 achieves better brain absorption while maintaining lower blood lithium levels, potentially eliminating the need for therapeutic drug monitoring (TDM).

AL001 aims to overcome limitations of current FDA-approved lithium salts, which require regular monitoring due to a narrow therapeutic window. While lithium lacks FDA approval for MDD treatment, it has been prescribed off-label for decades as an antidepressant augmentation therapy, showing efficacy in multiple randomized controlled trials.

Positive

• Successful completion of head coil development, enabling Phase II trial progression
• Previous mouse studies demonstrated superior brain absorption with lower blood lithium levels
• Potential to eliminate need for therapeutic drug monitoring, reducing treatment burden
• Large addressable market of over 21 million Americans with MDD

Negative

• Phase II trial won't begin until Q4 2025, indicating a lengthy timeline to potential commercialization
• AL001 still lacks FDA approval for MDD treatment
• Competition from existing FDA-approved lithium treatments in the market

• Head-to-head studies of AL001 versus a marketed lithium carbonate product will be conducted for comparisons of lithium blood and brain/brain-structure pharmacokinetics in MDD subjects
  

ATLANTA, March 18, 2025 (GLOBE NEWSWIRE) -- 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 its plans to initiate a highly anticipated phase II clinical study of AL001 for treatment of patients with MDD in the fourth quarter of 2025. This study follows the successful completion of a head coil by Tesla Dynamic Coils BV, a key component of the clinical trial.

In collaboration with Massachusetts General Hospital as its contract research organization, Alzamend aims to explore the unique properties of AL001 and its effects on lithium delivery in the brain compared to marketed lithium salts. The study could illuminate the path forward in patients with MDD by demonstrating AL001’s targeted effectiveness and reduced systemic side effects. Previous studies in mice have shown that AL001 ensures better brain absorption while maintaining lower levels of lithium in the blood, paving the way for safer and more efficient treatments.

By offering a treatment that potentially eliminates the need for lithium therapeutic drug monitoring (“TDM”), AL001 could revolutionize care for vulnerable patient populations and improve treatment outcomes. Lithium, renowned for its efficacy as a first-line therapy for manic episodes and maintenance in BD, has long been underutilized due to the complexities of TDM. Current lithium salts (carbonate and citrate) approved by the U.S. Food and Drug Administration (“FDA”) 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. Although lithium does not have an FDA approved indication for augmentation of an antidepressant in MDD, it has been prescribed off-label for this purpose for decades. While a wide variety of medications have been used historically in this capacity, lithium is one of the few agents that has demonstrated efficacy in multiple randomized controlled trials. Although the ideal role for lithium augmentation has yet to be established, there is evidence to support the clinical practice of adding lithium to conventional antidepressants in pursuit of MDD remission.

“With AL001, we can potentially introduce a next-generation lithium treatment that offers enhanced safety, better brain targeting, and no need for TDM, promising a leap forward from the current, burdensome options,” stated Stephan Jackman, Chief Executive Officer of Alzamend. “This advancement stands to potentially enhance the lives of over 21 million Americans suffering from MDD by providing a more effective and user-friendly therapeutic option, potentially reshaping current treatment paradigms and improving patient quality of life substantially.”

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.

Contacts:
Email: Info@Alzamend.com or call: 1-844-722-6333

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/071d71e0-5561-409c-9f64-3d579b633cc7

https://www.globenewswire.com/NewsRoom/AttachmentNg/4b19dc00-6745-4ecd-a229-4499449361e0

FAQ

When will Alzamend Neuro (ALZN) begin its Phase II trial for AL001 in MDD treatment?

Alzamend plans to initiate the Phase II clinical trial in the fourth quarter of 2025 at Massachusetts General Hospital.

What advantages does ALZN's AL001 have over traditional lithium treatments?

AL001 shows better brain absorption with lower blood lithium levels, potentially eliminating the need for therapeutic drug monitoring while offering enhanced safety and better brain targeting.

How many Americans could potentially benefit from ALZN's AL001 MDD treatment?

Over 21 million Americans suffering from Major Depressive Disorder could potentially benefit from AL001 as a therapeutic option.

What is the current limitation of FDA-approved lithium treatments that ALZN's AL001 aims to address?

Current lithium treatments have a narrow therapeutic window requiring regular monitoring of plasma lithium levels and blood chemistry, which AL001 aims to eliminate.