Alzamend Neuro Collaborates with Massachusetts General Hospital for Advanced MDD Treatment Trial
TL;DR
Alzamend Neuro, Inc. is developing a next-generation lithium-based therapeutic candidate for Major Depressive Disorder (MDD), offering a potential advantage in the treatment of MDD.
Al001 is a next-generation lithium-based therapeutic candidate being studied by Alzamend Neuro, Inc. and Massachusetts General Hospital to determine its effectiveness and safety for MDD, bipolar disorder, and Alzheimer's.
The partnership between Alzamend Neuro, Inc. and Massachusetts General Hospital to develop new treatments for MDD, bipolar disorder, and Alzheimer's has the potential to positively impact millions of people affected by these conditions.
Alzamend Neuro, Inc. and Massachusetts General Hospital's collaboration to conduct Phase II clinical trials for a next-generation lithium therapeutic candidate offers an innovative approach to addressing mental health conditions.
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Major Depressive Disorder (MDD) is projected to become the leading cause of global disease burden by 2030, according to the World Health Organization. Addressing this pressing healthcare issue, Alzamend Neuro, Inc. (NASDAQ:ALZN), a clinical-stage biopharmaceutical company, has announced a collaboration with Massachusetts General Hospital (MGH) to conduct a Phase II clinical trial of AL001, a next-generation lithium-based therapeutic candidate designed to enhance the safety and efficacy of traditional lithium treatments for MDD.
Lithium has long been used off-label to treat MDD, but its application is limited by safety concerns due to its narrow therapeutic window. AL001 aims to mitigate these concerns by improving the safety profile and effectiveness of lithium treatment. The trial will be led by Dr. Ovidiu Andronesi, an Associate Professor of Radiology at Harvard University, and will compare the effectiveness and safety of AL001 to 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 deliver lithium at safe and effective levels without the need for frequent monitoring. This is a significant advantage over current lithium treatments, which are often limited by chronic toxicity and poor physicochemical properties.
The primary objective of the Phase II trial is to determine the optimal dose of AL001 that can achieve comparable or improved effectiveness and safety relative 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, highlighted the potential of AL001 to be a next-generation lithium product with an improved safety profile and enhanced brain biodistribution. He emphasized that developing such a product could eliminate the need for routine therapeutic drug monitoring (TDM) and represent a significant advancement over existing lithium-based treatments. This innovation 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 compare brain lithium levels between AL001 and commonly marketed lithium salts, seeking to optimize dosing for enhanced effectiveness and safety.
Alzamend Neuro has recently secured $25 million in funding to advance its clinical trials and further develop next-generation treatments for Alzheimer’s, bipolar disorder, MDD, and PTSD. This investment underscores the company's commitment to achieving clinical milestones and transforming lithium-based therapies for millions of people affected by these conditions.
Curated from News Direct
