Alzamend Neuro and Massachusetts General Hospital Launch Phase II Trial for Novel MDD Treatment

Alzamend Neuro, Inc. (NASDAQ:ALZN), a clinical-stage biopharmaceutical company, has announced a significant partnership with Massachusetts General Hospital (MGH) to conduct a Phase II clinical trial of AL001, a novel lithium-based therapeutic candidate for Major Depressive Disorder (MDD). This collaboration marks a crucial step in addressing the growing global burden of MDD, which the World Health Organization projects could become the leading cause of disease burden by 2030.

The study, led by Dr. Ovidiu Andronesi, Associate Professor of Radiology at Harvard University, aims to compare AL001's effectiveness and safety against a marketed lithium carbonate product. The trial will focus on examining lithium levels in the brain and its structures, building upon Alzamend's previous Phase IIA trial that identified a maximum tolerated dose (MTD) for AL001.

MDD affects over 21 million Americans and is characterized by persistent sadness, loss of interest in activities, and difficulties in daily functioning. While lithium has been used off-label for MDD, its application is limited due to safety concerns and a narrow therapeutic window. AL001 is designed to provide lithium at a safe and effective level without the need for frequent monitoring, potentially overcoming the limitations of current lithium treatments.

Stephan Jackman, CEO of Alzamend Neuro, expressed optimism about the partnership, highlighting AL001's potential as a next-generation lithium product with an improved safety profile and enhanced brain biodistribution. The company aims to eliminate the need for routine therapeutic drug monitoring, which could represent a significant advancement over existing lithium-based treatments.

The study's primary goal is to determine the ideal dose of AL001 that can achieve similar or better effectiveness and safety compared to existing lithium salts. Alzamend is pursuing the FDA's Section 505(b)(2) pathway, which allows for new formulations of approved drugs, potentially streamlining the regulatory process.

In addition to the MDD trial, Alzamend Neuro is also partnering with MGH for Phase II clinical trials of AL001 in patients with bipolar disorder (BD) and Alzheimer's disease. These trials, also led by Dr. Andronesi, aim to compare the increase in brain lithium levels between AL001 and commonly marketed lithium salts in both patient populations and healthy subjects.

To support these ambitious clinical programs, Alzamend Neuro recently secured the initial two tranches under a $25 million purchase agreement. This funding will drive the progress of Alzamend's clinical trials and the development of next-generation treatments for Alzheimer's, bipolar disorder, MDD, and PTSD.

The development of AL001 represents a potential paradigm shift in the treatment of MDD and other neurological and psychiatric disorders. By addressing the limitations of current lithium treatments, Alzamend Neuro aims to provide a more effective and safer option for millions of patients worldwide. The success of these trials could have far-reaching implications for the field of mental health treatment and potentially improve the quality of life for those affected by these debilitating conditions.

As the trials progress, the medical community and patients alike will be watching closely to see if AL001 can deliver on its promise of a next-generation lithium therapy. The partnership between Alzamend Neuro and Massachusetts General Hospital underscores the importance of collaboration in advancing medical research and addressing critical unmet needs in mental health treatment.