Alzamend Neuro Kicks Off First Phase 2 Study for Lead Candidate in 2025

Alzamend Neuro, Inc. (Nasdaq: ALZN), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder, is set to commence its first Phase 2 study for its lead candidate, AL001, in 2025. The study, in healthy human subjects, will follow the development of a novel head coil by Tesla Dynamic Coils BV, a key component of the clinical trial. The head coil will enable whole-brain imaging of lithium with remarkable resolution, allowing precise quantification within brain structures and helping identify the disease-specific target doses of AL001 that improve the balance of safety and efficacy compared to lithium carbonate.

The completion of the head coil by Tesla marks a significant milestone in the development of AL001, as it paves the way for the five upcoming Phase II clinical trials to be conducted by Alzamend. The coil will also be used to scan the entire brain, helping researchers clearly identify different structures and important areas necessary for understanding how lithium works and moves within the brain. This innovative approach ensures that lithium via AL001 remains effective in the brain with significantly reduced risks of harmful side effects on the kidneys and thyroid, potentially removing the need for lithium therapeutic drug monitoring (TDM).



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.



The multi-indication strategy for AL001 has the potential to significantly expand the drug’s market potential and accelerate its regulatory pathway. By targeting multiple indications, AL001 could reach a larger patient population, increasing its market potential. According to the World Health Organization, depression affects 264 million people of all ages globally, while anxiety disorders affect 284 million people. PTSD affects approximately 7-8% of the U.S. population, and bipolar disorder affects around 2.8% of U.S. adults. Alzheimer’s disease affects an estimated 50 million people worldwide. With AL001 targeting all these conditions, it could potentially treat a significant portion of these patients, leading to a substantial market opportunity.

In conclusion, the commencement of the first Phase 2 study for AL001 in 2025 marks a significant step forward in the development of this novel lithium-delivery system. The completion of the Tesla head coil has accelerated the timeline for the clinical trials and made them more feasible by providing clear pharmacokinetic endpoints and enabling more informed dose selection. The multi-indication strategy for AL001 has the potential to significantly expand the drug’s market potential and accelerate its regulatory pathway, ultimately enhancing the drug’s commercial success. Investors should closely monitor the progress of these clinical trials and the potential market opportunities for AL001.