Alzamend Neuro, Inc. announced receipt of a "Study May Proceed" letter from the U.S. Food and Drug Administration ("FDA") for the initiation of study AL001-PTSD01, a Phase IIA clinical study of AL001 for treatment of patients with PTSD. AL001 is a novel lithium-delivery system that has the potential to deliver benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. Results from Alzamend?s recently 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 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.

Although lithium products do not have an FDA-approved indication for PTSD, case reports suggest that lithium treatment may be useful for treating PTSD patients. Specifically, treatment with low doses (300?600 mg/day) of lithium carbonate have been reported to provide effective treatment in reduction of inappropriate anger, irritability, anxiety, and insomnia in patients with PTSD. Alzamend?s goal is to revive the utility of lithium treatment by importantly improving the benefit-to-risk relationship of lithium treatment in clinical practice.

Based on the favorable AL001 safety profile observed in the recently completed study and extensive safety data on the drug?s constituent components, the AL001 development program may qualify for a Section 505(b)(2) New Drug Application (?NDA?) pathway for FDA approval, which is available to new formulations of an approved drug. PTSD is a mental and behavioral disorder that can develop because of exposure to a traumatic event, such as sexual assault, warfare, traffic collisions, child abuse, domestic violence, or other threats on a person?s life (American Psychiatric Association DSM-5-TR, 2020; Mayo Clinic, 2022). People who experience interpersonal violence, such as rape, other sexual assaults, being kidnapped, stalking, physical abuse by an intimate partner, and incest or other forms of childhood sexual abuse, are more likely to develop PTSD than those who experience non-assault-based trauma, such as accidents and natural disasters.

Symptoms may include disturbing thoughts, feelings, or dreams related to the events, mental or physical distress in response to trauma-related cues, attempts to avoid trauma-related cues, alterations in the way a person thinks and feels, and an increase in the fight-or-flight response. These symptoms last for more than a month after the event (American Psychiatric Association DSM-5-TR, 2020). A person with PTSD is at a higher risk of suicide and intentional self-harm.

According to the NIH, about 3.6%, or roughly 9 million, adults in the U.S. have PTSD in a given year, and 9% of people develop it at some point in their life. In much of the rest of the world, rates for a given year are between 0.5% and 1% of the population. Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer?s, BD, MDD and PTSD.

mission is to rapidly develop and market safe and effective treatments. 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. Both of product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.