Alzamend Neuro Announces Completion of a Novel Head Coil by Tesla for Measuring Brain Structure Lithium Levels in Five Upcoming Phase II Clinical Trials at Massachusetts General Hospital

By: Alzamend Neuro, Inc. via Business Wire

February 19, 2025 at 08:00 AM EST

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 healthy, Alzheimer’s disease, BD, MDD, and PTSD subjects

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 the completion of a groundbreaking head coil by Tesla Dynamic Coils BV (“Tesla”). The development of the head coil was necessary to facilitate the five upcoming Phase II clinical trials to be conducted by Alzamend.

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Tesla Head Coil (Tesla Dynamic Coils BV) Photo Courtesy of Alzamend Neuro, Inc. All rights reserved and proprietary, @2025 #Alzamend @Alzamend $Alzamend @LiProSal #LiProSal $LiProSal #MassachusettsGeneralHospital $MassachusettsGeneralHospital #Whole-brain_imaging $whole-brain_imaging #one-of-a-kind_head_coil $one-of-s-kind_head_coil (Photo: Business Wire)

In collaboration with Massachusetts General Hospital as its contract research organization, Alzamend intends to undertake pioneering clinical trials, with a goal to assess how lithium levels in the brain differ when using AL001 compared to marketed lithium salts, both in healthy individuals and patients with Alzheimer’s, BD, MDD and PTSD. The one-of-a-kind engineered head coil will enable whole-brain imaging of lithium with remarkable resolution, allowing precise quantification within brain structures. The coil will be used to help identify the disease-specific target doses of AL001 that improve the balance of safety and efficacy compared to lithium carbonate. The coil will also be used to scan the entire brain, helping us clearly identify the different structures and important areas necessary for understanding how lithium works and moves within the brain.

These studies are expected to provide greater clarity on how lithium treatments reach the brain, showcasing AL001’s superior ability to target brain structures while reducing systemic exposures. Nonclinical (mouse) studies have already demonstrated that AL001 optimizes brain absorption with lower blood concentration levels when compared to lithium carbonate, suggesting promising human applications. This cutting-edge approach ensures that lithium via AL001 remains effective in the brain with significantly reduced risks of harmful side effects on the kidneys and thyroid. By enabling safer dosing, expanding the therapeutic index and potentially removing the need for lithium therapeutic drug monitoring (“TDM”), AL001 represents a potential groundbreaking advance. These innovations could deliver more effective and secure treatments to vulnerable groups, such as Alzheimer’s patients, highlighting AL001’s potential in improving patient care and treatment efficacy.

“We want to thank Tesla for working with us to create this one-of-a-kind lithium head coil,” stated Stephan Jackman, Chief Executive Officer of Alzamend. “The development of the coil was a long time coming, but we believe the time and effort was necessary to allow us unprecedented knowledge as to how lithium interacts within our brains. We believe that our upcoming studies, utilizing the head coil, has the potential to broaden the application of lithium treatment across numerous neurodegenerative diseases and psychiatric disorders. Its completion allows us to solidify our timeline for the forthcoming clinical trials in collaboration with Massachusetts General Hospital. We look forward to sharing additional details regarding these trials soon.”

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250219041710/en/

Contacts

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

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Alzamend Neuro Announces Completion of a Novel Head Coil by Tesla for Measuring Brain Structure Lithium Levels in Five Upcoming Phase II Clinical Trials at Massachusetts General Hospital

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