Alzamend Neuro, a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for Alzheimer’s disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder, announced its partnership with Massachusetts General Hospital (Mass General) to conduct a Phase II clinical trial of AL001 for Alzheimer’s patients. The trial will also include a healthy subjects cohort to compare their plasma and brain pharmacokinetics with those of Alzheimer’s patients.
Mass General, the largest clinical education and research facility of Harvard Medical School, houses the world’s largest hospital-based research program. Dr. Ovidiu Andronesi, MD, PhD, Associate Professor of Radiology at Harvard University and Director of Multinuclear Metabolic Imaging at the Martinos Center for Biomedical Imaging, will be the principal investigator of the study.
The trial aims to compare the increase in lithium levels within the brain and its structures in Alzheimer’s patients to a commonly marketed lithium salt. By examining the lithium content in the brains of patients during treatments, Alzamend aims to determine the minimum effective dose of AL001. The goal is to meet the regulatory safety standards for approval by the U.S. Food and Drug Administration through the Section 505(b)(2) pathway, which is designed for new formulations of approved drugs.
Alzamend previously completed a Phase IIA multiple ascending dose clinical trial, identifying a maximum tolerated dose (MTD) for AL001, which provides lithium at an equivalent dose of 240 mg three times daily. This dose is designed to avoid the need for lithium therapeutic drug monitoring (TDM) and is considered safe for fragile populations, such as Alzheimer’s patients.
“We are elated to partner with Mass General and Dr. Andronesi in this pivotal study for our lead therapeutic candidate AL001,” said Stephan Jackman, CEO of Alzamend. “If we can develop a next-generation lithium product with an improved safety profile and enhanced biodistribution in the brain that does not routinely require TDM, it would constitute a major improvement over current lithium-based treatments and positively impact the 6+ million Americans afflicted with Alzheimer’s. We look forward to providing more details regarding the study’s timeline and market opportunity in the near future.”
About AL001
AL001 is a novel lithium-delivery system designed to deliver the benefits of marketed lithium salts while reducing or avoiding current lithium toxicities. Results from Alzamend’s completed Phase IIA study identified an MTD unlikely to require TDM, providing lithium at a modest but effective dose. AL001 is designed to favorably distribute lithium in the brain, resulting in lower exposure to other body organs and an improved safety profile compared to currently marketed lithium salts. This innovation aims to mitigate the low toxicity ceiling of current lithium salts, enhancing their usefulness to patients and prescribers.
