Alzamend Neuro, Inc. has announced a collaboration with Massachusetts General Hospital (MGH) to conduct a Phase II clinical trial of AL001, a next-generation lithium therapeutic drug candidate, for patients with bipolar disorder (BD). The study aims to compare AL001 against a marketed lithium carbonate product to identify an optimal, safe, and effective dose.
Study Design and Objectives
The Phase II trial will be led by Dr. Ovidiu Andronesi, an Associate Professor of Radiology at Harvard University and Director of Multinuclear Metabolic Imaging at MGH. The study will focus on assessing the comparative increase in lithium levels within the brain and its structures using AL001 versus a standard lithium salt in BD patients. By examining lithium content in the brain, Alzamend aims to determine the minimum dose of AL001 needed to achieve equivalent effectiveness and safety as current lithium treatments.
AL001: A Next-Generation Lithium Therapy
AL001 is designed as a novel lithium-delivery system intended to provide the benefits of marketed lithium salts while reducing the associated toxicities. Alzamend has previously completed a Phase IIa multiple ascending dose clinical trial, identifying a maximum tolerated dose (MTD) for AL001. This MTD, equivalent to 240 mg of lithium carbonate three times daily, is designed to minimize the need for therapeutic drug monitoring (TDM).
Addressing the Limitations of Current Lithium Treatments
Currently approved lithium salts, such as lithium carbonate and citrate, require regular TDM due to their narrow therapeutic window and potential for adverse events. These conventional lithium salts are eliminated quickly, necessitating multiple daily administrations to maintain therapeutic plasma concentrations. AL001 aims to overcome these limitations by improving brain bioavailability and reducing exposure to other organs, potentially leading to a better safety profile.
Clinical and Market Implications
Stephan Jackman, CEO of Alzamend, stated, "If we can develop a next-generation lithium product (AL001) with an improved safety profile and enhanced biodistribution in the brain that would not routinely require TDM, it would constitute a major improvement over current lithium-based treatments and positively impact the 7+ million Americans afflicted with BD."
The development of AL001 is particularly relevant given that lithium remains a first-line treatment for bipolar disorder, despite its limitations. A safer, more effective lithium therapy could significantly improve the management of this condition.
