Alzamend Neuro and Massachusetts General Hospital Launch Phase II Trial of AL001 for Alzheimer's

Alzamend Neuro, Inc., a biopharmaceutical company in the clinical stage, has announced a significant development in its effort to combat Alzheimer's disease. The company has initiated a collaboration with Massachusetts General Hospital (Mass General) to conduct a Phase II clinical trial of AL001, a novel treatment for Alzheimer’s patients. This study also includes a healthy subjects cohort to compare plasma and brain pharmacokinetics between healthy individuals and those with Alzheimer's.

Mass General, a prestigious clinical education and research institution affiliated with Harvard Medical School, will serve as the contract research organization (CRO) for this trial. Dr. Ovidiu Andronesi, an Associate Professor of Radiology at Harvard University and the Director of Multinuclear Metabolic Imaging at Mass General, has been appointed as the principal investigator for the study.

The primary goal of this innovative trial is to evaluate the increase in lithium levels within the brain and its structures, comparing AL001 to a commonly used lithium salt. By analyzing lithium content in the brain during treatments, Alzamend aims to determine the minimum effective dose of AL001 that offers the same safety and efficacy as established lithium salts. The company is hopeful that the findings will help meet regulatory safety standards for approval by the U.S. Food and Drug Administration (FDA) through the Section 505(b)(2) pathway, which is intended for new formulations or delivery systems of an already approved drug.

Previously, Alzamend successfully completed a Phase IIA clinical trial, identifying a maximum tolerated dose (MTD) for AL001. This dose, equivalent to 240 mg of lithium carbonate taken three times daily, is designed to avoid the need for lithium therapeutic drug monitoring (TDM). The MTD is specifically tailored to be safe for delicate populations, including Alzheimer’s patients.

Stephan Jackman, CEO of Alzamend, expressed enthusiasm about the partnership with Mass General and Dr. Andronesi. He highlighted that developing AL001, a next-generation lithium product with an improved safety profile and enhanced brain biodistribution that does not typically require TDM, could represent a significant advancement over current lithium treatments. Such a development could positively impact the more than six million Americans suffering from Alzheimer’s disease. Jackman also mentioned that further details regarding the study's timeline and market opportunities would be shared soon.

AL001 is a unique lithium delivery system designed to offer the benefits of existing lithium salts while reducing the associated toxicities. The Phase IIA trial demonstrated that AL001 could deliver lithium effectively at a modest dose without necessitating TDM. The treatment aims to favorably distribute lithium in the brain, thereby lowering exposure to other body organs and improving the safety profile compared to current lithium salts. This could potentially eliminate the toxicity issues that have limited the broader use of lithium salts.

Alzamend Neuro's mission is to swiftly develop and market safe and effective treatments for neurological disorders, including Alzheimer's, bipolar disorder, major depressive disorder, and post-traumatic stress disorder. The company's pipeline features two innovative therapeutic candidates: AL001 and ALZN002. AL001 uses patented ionic cocrystal technology to deliver lithium via a therapeutic combination, while ALZN002 employs a cell-based therapeutic vaccine approach to restore the body’s ability to combat Alzheimer's by removing beta-amyloid from the brain. Both candidates are licensed from the University of South Florida Research Foundation under exclusive worldwide agreements.

Alzamend's efforts in developing these novel treatments underscore its commitment to addressing the unmet needs of patients with neurodegenerative and psychiatric disorders.