ATLANTA– Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced that it is partnering with Massachusetts General Hospital (“Mass General”) as its contract research organization (“CRO”) to conduct a Phase II clinical trial of AL001 for treatment of patients with Alzheimer’s. A healthy subjects cohort will also be studied to permit comparisons of their plasma and brain pharmacokinetics to that of patients with Alzheimer’s. Mass General is the original and largest clinical education and research facility of Harvard Medical School/Harvard University and houses the world’s largest hospital-based research program.
Alzamend and Mass General have contracted with Dr. Ovidiu Andronesi MD, PhD, to be the principal investigator on the study. Dr. Andronesi is Associate Professor of Radiology at Harvard University and the Director of Multinuclear Metabolic Imaging, Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School.
The objective of this novel trial is to assess the comparative increase in lithium levels within the brain and its structures as opposed to a commonly marketed lithium salt among Alzheimer’s patients and healthy subjects. By examining the lithium content in the brains and brain structures of patients during treatments, Alzamend aims to predict the minimum dose necessary to achieve the equivalent effectiveness and safety of AL001 in contrast to established lithium salts. Alzamend is optimistic that this study will assist in meeting the regulatory safety standards through the Section 505(b)(2) pathway for approval by the U.S. Food and Drug Administration, which is specifically designed for new formulations/delivery systems of an approved drug.
Alzamend previously completed a Phase IIA multiple ascending dose clinical trial, in which it successfully identified a maximum tolerated dose (“MTD”) for development of AL001, as assessed by an independent safety review committee. This dose, providing lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily, is designed to be unlikely to require lithium therapeutic drug monitoring (“TDM”). This MTD is risk mitigated for the purpose of treating 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, Chief Executive Officer of Alzamend. “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 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.”
