Alzamend Neuro Partners with Massachusetts General Hospital for Phase II Trial of Novel Lithium-Based Treatment for Major Depressive Disorder

Alzamend Neuro, Inc. (NASDAQ:ALZN) has announced a 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). The disorder, projected to become the leading cause of global disease burden by 2030 according to the World Health Organization, 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 treatment, its narrow therapeutic window has limited its application due to safety concerns.

The Phase II trial, led by Dr. Ovidiu Andronesi, an Associate Professor of Radiology at Harvard University, aims to compare AL001's effectiveness and safety against a marketed lithium carbonate product. The study will focus on examining lithium levels in the brain and its structures, with the goal of determining the ideal dose of AL001 that can achieve similar or better effectiveness and safety compared to existing lithium salts. Alzamend Neuro previously completed a Phase IIA trial that identified a maximum tolerated dose (MTD) for AL001, designed to provide lithium at a safe and effective level without the need for frequent monitoring, addressing a key limitation of current lithium treatments.

Stephan Jackman, Chief Executive Officer of Alzamend Neuro, expressed optimism about the potential of AL001 to be a next-generation lithium product with an improved safety profile and enhanced brain biodistribution. If successful, this could eliminate the need for routine therapeutic drug monitoring, representing a significant advancement over existing lithium-based treatments. The company is pursuing the FDA's Section 505(b)(2) pathway for AL001, which allows for new formulations of approved drugs and could potentially streamline the regulatory process and bring the treatment to market more quickly.

In addition to the MDD trial, Alzamend Neuro is also partnering with MGH to conduct Phase II clinical trials of AL001 for 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 has recently secured the initial two tranches under a $25 million purchase agreement. This funding will drive the progress of the company's clinical trials and the development of next-generation treatments for Alzheimer's, bipolar disorder, MDD, and PTSD.

The collaboration between Alzamend Neuro and Massachusetts General Hospital represents a significant step forward in the quest for improved treatments for major mental health disorders. If successful, AL001 could offer hope to millions of patients who struggle with the limitations and side effects of current lithium-based therapies. As the clinical trials progress, the medical community and patients alike will be watching closely to see if AL001 can deliver on its promise of a safer, more effective lithium treatment. The potential impact on the lives of those affected by MDD, bipolar disorder, and Alzheimer's disease could be substantial, marking a new era in the treatment of these challenging conditions.