Alzamend Neuro, Inc. (NASDAQ: ALZN), a clinical-stage biopharmaceutical company, has announced a significant collaboration with Massachusetts General Hospital (MGH) to initiate a Phase II clinical trial of AL001, an innovative lithium-based therapeutic candidate for the treatment of Major Depressive Disorder (MDD). This partnership aims to address the limitations of current lithium treatments, which are hindered by safety concerns and the need for frequent monitoring due to their narrow therapeutic window.
Major Depressive Disorder (MDD) is a severe mental health condition characterized by persistent sadness, loss of interest in activities, and challenges in daily functioning. According to the World Health Organization, MDD was the third leading cause of global disease burden in 2008, with projections indicating it could become the leading cause by 2030. Lithium, a well-known mood stabilizer, has been used off-label for MDD, but its application is limited by chronic toxicity and poor physicochemical properties.
The Phase II trial, led by Dr. Ovidiu Andronesi, an Associate Professor of Radiology at Harvard University, will compare the effectiveness and safety of AL001 against a marketed lithium carbonate product by examining lithium levels in the brain and its structures. 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.
Stephan Jackman, Chief Executive Officer of Alzamend Neuro, expressed enthusiasm about the partnership with MGH and Dr. Andronesi. Jackman highlighted the potential of AL001 to be a next-generation lithium product with an improved safety profile and enhanced brain biodistribution, potentially eliminating the need for routine therapeutic drug monitoring (TDM). He emphasized that developing such a product would represent a significant advancement over existing lithium-based treatments and could positively impact the over 21 million Americans affected by MDD.
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 optimize dosing for enhanced effectiveness and safety. The bipolar disorder trial will compare brain lithium levels between AL001 and a commonly marketed lithium salt, while the Alzheimer’s trial will evaluate the increase in brain lithium levels and its distribution in both Alzheimer’s patients and healthy subjects.
Furthermore, Alzamend Neuro recently secured the initial two tranches under a $25 million purchase agreement to fund the progress of its clinical trials and the development of next-generation treatments for Alzheimer’s, bipolar disorder, MDD, and PTSD. Jackman highlighted the company’s commitment to achieving clinical milestones and transforming lithium-based therapies for millions of people affected by these conditions.
The outcomes of these trials could potentially revolutionize the treatment landscape for MDD and other neurological and psychiatric disorders, offering safer and more effective alternatives to current lithium treatments. As Alzamend Neuro continues to advance its clinical programs, the healthcare community and patients alike eagerly anticipate the potential benefits that these innovative therapies could bring.
