Alzamend Neuro Partners with Massachusetts General Hospital for Phase II Trial of AL001

Alzamend Neuro, Inc. (NASDAQ: ALZN) has announced a groundbreaking partnership with Massachusetts General Hospital (MGH) to conduct Phase II clinical trials of its promising drug candidate AL001. These trials will focus on patients suffering from bipolar disorder and Alzheimer's disease, aiming to establish AL001's safety, effectiveness, and tolerable dosing requirements.

Mental health issues are increasingly prevalent, affecting nearly 60 million adults in the United States and over 970 million people globally. Alzamend Neuro is dedicated to developing next-generation treatments for mental health disorders, including Alzheimer's disease, bipolar disorder, major depressive disorder (MDD), and post-traumatic stress disorder (PTSD). Among its pipeline, AL001 stands out for its potential to revolutionize bipolar disorder treatment.

AL001 employs a patented ionic cocrystal technology designed to deliver lithium in a manner that reduces toxicity while maintaining therapeutic efficacy. This innovative approach combines lithium, salicylate, and L-proline to achieve these results. Previous Phase I and Phase IIA trials for Alzheimer's patients and healthy subjects have demonstrated a benign safety profile for AL001.

Dr. Ovidiu Andronesi, MD, PhD, Associate Professor of Radiology at Harvard University and Director of Multinuclear Metabolic Imaging at the Martinos Center for Biomedical Imaging, will lead the study. The trial will compare AL001 to a marketed lithium carbonate product, focusing on bioavailability and brain distribution of lithium. The goal is to establish AL001's safe, effective, and tolerable dosing requirements.

One of the most compelling aspects of AL001 is its potential to offer the therapeutic benefits of traditional lithium salts while minimizing their toxic side effects. Current lithium treatments require rigorous therapeutic drug monitoring (TDM) due to their narrow therapeutic window and potential toxicity. AL001 aims to eliminate the need for TDM, simplifying treatment regimens and improving patient compliance.

In addition to bipolar disorder, AL001 is also being tested for Alzheimer's disease. This trial will involve both Alzheimer's patients and healthy subjects, comparing the bioavailability and brain distribution of AL001 versus a marketed lithium carbonate product. The study will leverage advanced brain imaging techniques to predict the efficacy and safety of AL001, providing invaluable insights into how the drug works.

Alzamend Neuro's CEO, Stephan Jackman, expressed optimism about the partnership, stating, "If we can develop a next-generation lithium product (AL001) with an improved safety profile and enhanced biodistribution in the brain that would not routinely require therapeutic drug monitoring (TDM), it would constitute a major improvement over current lithium-based treatments and positively impact the 7+ million Americans afflicted with bipolar disorder."

Financially, Alzamend Neuro has secured the first two tranches of a $25 million Series A purchasing agreement to support the advancement of its clinical trials. This investment underscores the potential market opportunity and the company's commitment to revolutionizing lithium-based therapies.

If successful, AL001 could pave the way for a new era in the treatment of bipolar disorder and Alzheimer's disease, offering hope to millions of patients and their families.