Alzamend Neuro and Massachusetts General Hospital Launch Phase II Trial for AL001 in Bipolar Disorder Patients

Alzamend Neuro, Inc. (Nasdaq: ALZN), a biopharmaceutical company in the clinical stage, has announced a collaboration with Massachusetts General Hospital for a pioneering Phase II clinical trial of AL001 aimed at treating bipolar disorder (BD). Massachusetts General Hospital, affiliated with Harvard Medical School/Harvard University, is renowned for being the largest clinical education and research facility, and it plays a pivotal role in this innovative study.

The principal investigator for this study is Dr. Ovidiu Andronesi, an Associate Professor of Radiology at Harvard University and the Director of Multinuclear Metabolic Imaging at the Martinos Center for Biomedical Imaging within Massachusetts General Hospital. His expertise is expected to significantly contribute to the study’s success.

Lithium, which has been utilized for over 35 years and is widely regarded as the "gold standard" for BD treatment, is the cornerstone of this research. The primary goal of the trial is to measure the increase in lithium levels within the brain and its structures in patients treated with AL001, compared to traditional lithium salts. This comparison aims to identify the minimum effective dose of AL001 that maintains the same efficacy and safety as existing lithium treatments.

The study is designed to mitigate regulatory challenges associated with safety data by leveraging existing human toxicology knowledge of lithium, thereby potentially easing the approval process under the U.S. FDA's Section 505(b)(2) pathway. This pathway is intended for new formulations or delivery systems of already approved drugs.

Alzamend has already completed a Phase IIA multiple ascending dose clinical trial, which successfully determined a maximum tolerated dose (MTD) for AL001. This dose equates to a lithium carbonate equivalent of 240 mg administered three times daily and is believed to not require routine therapeutic drug monitoring (TDM). This is a significant improvement over current lithium treatments, which have a narrow therapeutic window necessitating regular monitoring to avoid adverse effects. Conventional lithium salts are rapidly eliminated from the body, requiring multiple daily doses to maintain therapeutic levels, and are associated with chronic toxicity and poor brain bioavailability.

Stephan Jackman, CEO of Alzamend, expressed enthusiasm about the partnership with Massachusetts General Hospital and Dr. Andronesi. He highlighted the potential impact of AL001, which, if successful, could offer a safer lithium product with better brain distribution and no need for frequent TDM. This advancement could benefit over seven million Americans suffering from BD.

AL001 is a novel lithium-delivery system developed to offer the benefits of traditional lithium salts while avoiding their associated toxicities. The data from the Phase IIA trial indicated that the MTD of AL001 does not require TDM, providing lithium at a lower but effective dose and favoring brain distribution. This characteristic could reduce exposure to other organs and improve the safety profile compared to existing lithium salts, which are limited by their toxicity.

Alzamend Neuro, dedicated to developing treatments for Alzheimer’s, BD, major depressive disorder (MDD), and post-traumatic stress disorder (PTSD), aims to bring safe and effective products to market swiftly. Besides AL001, Alzamend’s pipeline includes ALZN002, a cell-based therapeutic vaccine for Alzheimer’s. This approach seeks to restore the immune system's ability to fight Alzheimer’s by removing beta-amyloid from the brain, potentially offering a more cost-effective and less frequent dosing alternative to current antibody treatments.

Both AL001 and ALZN002 are licensed from the University of South Florida Research Foundation, Inc., under exclusive worldwide licenses. Alzamend continues to focus on addressing the unmet needs in neurological disorders through innovative therapeutic approaches.

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