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

Alzamend Neuro, Inc. (NASDAQ:ALZN) has announced a significant partnership with Massachusetts General Hospital (MGH) to conduct Phase II clinical trials of its lead therapeutic candidate, AL001, for the treatment of bipolar disorder and Alzheimer's disease. This collaboration marks a crucial step in the development of a potentially game-changing treatment for mental health disorders that affect millions worldwide.

AL001, a patented ionic cocrystal technology developed by Alzamend Neuro, combines lithium, salicylate, and L-proline to deliver lithium in a way that potentially reduces toxicity while maintaining therapeutic efficacy. The upcoming trials will compare AL001 to a marketed lithium carbonate product, focusing on bioavailability and brain distribution of lithium.

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 studies as the Principal Investigator. The trials aim to establish AL001's safe, effective, and tolerable dosing requirements, leveraging advanced brain imaging techniques to predict efficacy and safety compared to existing lithium treatments.

Previous Phase IIA studies of AL001 in Alzheimer's patients and healthy subjects have demonstrated a benign safety profile, identifying a candidate dose that may not require therapeutic drug monitoring (TDM). This represents a significant advancement over current lithium treatments, which require rigorous monitoring due to their narrow therapeutic window and potential toxicity.

Stephan Jackman, CEO of Alzamend Neuro, expressed enthusiasm for 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."

The potential impact of AL001 extends beyond bipolar disorder. The Phase II trial for Alzheimer's disease will involve both patients and healthy subjects, comparing AL001's bioavailability and brain distribution to a marketed lithium carbonate product. This trial could pave the way for a new era in Alzheimer's treatment, offering hope to millions of patients and their families.

To support these groundbreaking trials, Alzamend Neuro has secured the first two tranches of a $25 million Series A purchasing agreement. This financial backing will facilitate the advancement of Alzamend's clinical trials and the development of next-generation treatments for Alzheimer's, bipolar disorder, major depressive disorder, and post-traumatic stress disorder.

The collaboration between Alzamend Neuro and Massachusetts General Hospital represents a significant step forward in the quest for more effective and safer treatments for mental health disorders. As the trials progress, the medical community and patients alike will be watching closely, hopeful for a breakthrough that could transform the landscape of mental health care.