Alzamend Neuro, Inc. (Nasdaq: ALZN), a clinical-stage biopharmaceutical company focused on developing treatments for Alzheimer’s disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder, has announced a partnership with Massachusetts General Hospital (Mass General). Mass General will serve as the contract research organization (CRO) for a Phase II clinical trial of AL001, a novel drug candidate for Alzheimer’s. The trial will also include a cohort of healthy subjects to compare their plasma and brain pharmacokinetics with those of Alzheimer’s patients. Mass General, affiliated with Harvard Medical School/Harvard University, is renowned for its extensive hospital-based research program.
Alzamend Neuro and Massachusetts General Hospital have enlisted Dr. Ovidiu Andronesi, MD, PhD, as the principal investigator for their Phase II clinical trial of AL001. Dr. Andronesi, an Associate Professor of Radiology at Harvard University and Director of Multinuclear Metabolic Imaging at the Martinos Center for Biomedical Imaging, will lead the study.
The trial aims to compare lithium levels in the brain between Alzheimer’s patients and healthy subjects, evaluating AL001 against a commonly used lithium salt. By monitoring brain lithium concentrations, Alzamend seeks to determine the optimal dose of AL001 for effectiveness and safety, potentially meeting FDA regulatory standards through the Section 505(b)(2) pathway for new drug formulations.
Previously, Alzamend completed a Phase IIA trial to establish the maximum tolerated dose (MTD) for AL001. This dose, equivalent to 240 mg of lithium carbonate taken three times daily, is designed to minimize the need for therapeutic drug monitoring (TDM) and reduce risks for vulnerable populations, including Alzheimer’s patients.
Stephan Jackman, CEO of Alzamend, expressed enthusiasm about the collaboration, noting that a next-generation lithium product with an improved safety profile and better brain distribution could significantly benefit the over 6 million Americans with Alzheimer’s.
About AL001
AL001 is an innovative lithium-delivery system that aims to offer the benefits of existing lithium salts while reducing associated toxicities. The Phase IIA study confirmed an MTD for AL001, which provides effective lithium levels with minimal need for TDM. This novel system is designed to enhance lithium delivery to the brain, potentially improving safety compared to current lithium salts and addressing their limitations.
About Alzamend Neuro
Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing new treatments for Alzheimer’s, bipolar disorder, major depressive disorder, and post-traumatic stress disorder. The company’s pipeline includes AL001, a patented lithium delivery technology, and ALZN002, a cell-based vaccine designed to enhance the immune system’s ability to combat Alzheimer’s. Both candidates are licensed from the University of South Florida Research Foundation.
