EXCLUSIVE: Alzamend Neuro Initiates First Phase 2 Trial Of Lead Program In Healthy Human Participants

Alzamend Neuro, Inc. ALZN on Tuesday announced the initiation of the first of five Phase 2 clinical studies of AL001, with the first study in healthy human subjects.

This study follows the development of a novel head coil by Tesla Dynamic Coils BV, a key component of the clinical trial.

In collaboration with Massachusetts General Hospital as its clinical trial site, Alzamend aims to explore AL001 and its potential to deliver lithium more effectively in the brain than marketed lithium salts.

The study in healthy human subjects will serve as a baseline and assist Alzamend to determine the best path forward in Alzheimer's, bipolar disorder, major depressive disorder, and post-traumatic stress disorder patients by demonstrating AL001's targeted effectiveness and reduced systemic side effects.

Topline data is expected by the end of 2025.

Also Read: EXCLUSIVE: Alzamend Neuro Partners with QMENTA To Advance AI-Powered Imaging For Is Phase 2 Trial Of Lead Program

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.

In March, Alzamend Neuro announced its plans to initiate a phase 2 clinical study of AL001 for patients with post-traumatic stress disorder in the fourth quarter of 2025.

In November 2024, Alzamend Neuro finished analyzing a nonclinical study's final full data set comparing brain and plasma lithium exposures between AL001 and lithium carbonate in Alzheimer's transgenic mice.

The study involved administering AL001 to 5XFAD mice, a recognized model for Alzheimer's research, to compare its effects against lithium carbonate, an FDA-approved and marketed API.

Mice received high or low doses, scaled to humans, of AL001 and lithium carbonate over 14 days to observe pharmacokinetic steady-state drug conditions.

Last week, the company's board of directors approved a one-for-nine reverse stock split of its common stock to maintain compliance with the minimum bid price requirement of $1.00 per share required to maintain continued listing on the Nasdaq Capital Market.

Price Action: At the last check on Tuesday, ALZN stock was up 6.57% to $5.49 during the premarket session.

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