Alzamend Neuro Partners with Massachusetts General Hospital for Phase II Trials of AL001 in Bipolar Disorder and Alzheimer's Treatment

Alzamend Neuro, Inc. (NASDAQ:ALZN) has announced a significant partnership with Massachusetts General Hospital (MGH) to conduct Phase II clinical trials of its innovative drug candidate, AL001, for the treatment of bipolar disorder and Alzheimer's disease. This collaboration marks a crucial step forward in the development of next-generation treatments for mental health disorders, potentially offering hope to millions of patients worldwide. AL001, Alzamend Neuro's patented ionic cocrystal technology, combines lithium, salicylate, and L-proline to deliver lithium in a way that aims to reduce toxicity while maintaining therapeutic efficacy.

The Phase II trials will compare AL001 to a marketed lithium carbonate product, focusing on bioavailability and brain distribution of lithium. The studies will be led by 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. The trials will leverage advanced brain imaging techniques to measure lithium levels directly in the brain and brain structures of patients. This approach is expected to provide invaluable insights into AL001's efficacy and safety, potentially establishing it as a safer and more effective alternative to traditional lithium treatments. Notably, 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).

Stephan Jackman, CEO of Alzamend Neuro, expressed enthusiasm 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." The potential impact of AL001 extends beyond bipolar disorder. The collaboration with MGH also includes a Phase II clinical trial for AL001 in the treatment of Alzheimer's disease. This trial will involve both Alzheimer's patients and healthy subjects, aiming to establish AL001's safe, effective, and tolerable dosing requirements for this devastating neurodegenerative condition.

The development of AL001 comes at a critical time, as mental health issues are on the rise, affecting almost 60 million US adults and more than 970 million people worldwide. The ability to offer a potentially safer and more effective alternative to traditional lithium treatments could revolutionize the management of bipolar disorder and Alzheimer's disease, improving patient outcomes and quality of life. To support these groundbreaking clinical trials, Alzamend Neuro has recently secured the first two tranches of a $25 million Series A purchasing agreement. This financial backing will enable the company to advance its clinical trials and continue developing next-generation treatments for various mental health disorders.

As Alzamend Neuro and Massachusetts General Hospital embark on these pivotal Phase II trials, the medical community and patients alike await the results with anticipation. If successful, AL001 could usher in a new era of mental health treatment, offering hope to millions of individuals affected by bipolar disorder and Alzheimer's disease. The collaboration between a leading biopharmaceutical company and one of the world's most prestigious research hospitals underscores the potential significance of this research in advancing the field of mental health care. More information about the company can be found at https://www.alzamend.com.