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Major Depressive Disorder (MDD) was the third leading cause of global disease burden in 2008, according to the World Health Organization, with projections that it could become the leading cause by 2030. MDD is a severe mental health condition marked by persistent sadness, loss of interest in activities, and difficulties in daily functioning.1
Lithium, a well-known mood stabilizer, has been used off-label for MDD, but its application is limited by safety concerns due to its narrow therapeutic window. In response to this unmet need, Alzamend Neuro, Inc. (NASDAQ:ALZN), a clinical-stage biopharmaceutical company, is dedicated to developing innovative treatments for neurological and psychiatric disorders, including MDD. The company's latest effort involves a promising partnership with Massachusetts General Hospital (MGH) to conduct a Phase II clinical trial of AL001, a next-generation lithium-based therapeutic candidate aimed at improving the safety and effectiveness of lithium treatment for MDD.
Dr. Ovidiu Andronesi, an Associate Professor of Radiology at Harvard University, will lead the study. This trial aims to compare AL001's effectiveness and safety against a marketed lithium carbonate product by examining lithium levels in the brain and its structures.
Alzamend Neuro, Inc. (NASDAQ:ALZN) previously completed a Phase IIA trial that identified a maximum tolerated dose (MTD) for AL001. This dose is designed to provide lithium at a safe and effective level without the need for frequent monitoring, unlike current lithium treatments that are limited by chronic toxicity and poor physicochemical properties.
The primary goal of this study is to determine the ideal dose of AL001 that can achieve similar or better effectiveness and safety compared to existing lithium salts. Alzamend is optimistic that the study will meet regulatory safety standards through the FDA's Section 505(b)(2) pathway, which allows for new formulations of approved drugs.
Stephan Jackman, Chief Executive Officer of Alzamend Neuro, Inc. (NASDAQ:ALZN), expressed enthusiasm about the partnership with Massachusetts General Hospital and Dr. Andronesi for the pivotal study of AL001. He highlighted the potential of AL001 to be a next-generation lithium product with an improved safety profile and enhanced brain biodistribution, which could eliminate the need for routine therapeutic drug monitoring (TDM).
Jackman emphasized that developing such a product would represent a significant advancement over existing lithium-based treatments and could have a positive impact on the over 21 million Americans affected by Major Depressive Disorder (MDD). Alzamend plans to share more details about the study’s timeline and market opportunities in the near future.
Alzamend Neuro and Massachusetts General Hospital Launch Phase II Trials of AL001 for Bipolar Disorder and Alzheimer’s
Alzamend Neuro, Inc. (NASDAQ:ALZN) 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 are also led by Dr. Ovidiu Andronesi, an Associate Professor of Radiology at Harvard University.
Lithium, the first mood stabilizer approved by the U.S. Food and Drug Administration (FDA), remains the gold standard for treating bipolar disorder (BD). With over 35 years of use, its safety profile is well established, which may reduce regulatory hurdles. This trial aims to compare the increase in brain lithium levels between AL001 and a commonly marketed lithium salt in BD patients, seeking to optimize dosing for enhanced effectiveness and safety.
As for the Alzheimer’s trial, a cohort of healthy subjects will be studied to compare their plasma and brain pharmacokinetics with those of Alzheimer's patients. This trial aims to evaluate the increase in brain lithium levels and its distribution between AL001 and a commonly marketed lithium salt in both Alzheimer's patients and healthy subjects.
Alzamend Neuro Secures $25 Million Funding to Advance Clinical Trials
Alzamend Neuro, Inc. (NASDAQ:ALZN) recently secured the initial two tranches under a $25 million purchase agreement. This investment will drive the progress of Alzamend's clinical trials and the development of next-generation treatments for Alzheimer’s, bipolar disorder, MDD, and PTSD. CEO Stephan Jackman highlighted the company’s commitment to achieving clinical milestones and transforming lithium-based therapies for millions of people affected by these conditions.
Click here for more information about Alzamend Neuro, Inc. (NASDAQ:ALZN).
[1] https://www.ncbi.nlm.nih.gov/books/NBK559078/
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