ALZN Stock – Alzamend Neuro Teams Up with Massachusetts General Hospital for Groundbreaking AL001 PTSD Trial

ALZN Stock – ATLANTA–(BUSINESS WIRE)–Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company dedicated to advancing innovative treatments for Alzheimer’s disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder (PTSD), has announced a pivotal partnership with Massachusetts General Hospital. This collaboration aims to conduct a groundbreaking Phase II clinical study of AL001, targeting PTSD patients. Massachusetts General Hospital, a leading institution affiliated with Harvard Medical School and home to the world’s largest hospital-based research program, will serve as the contract research organization (CRO) for this study.

Dr. Ovidiu Andronesi to Lead Phase II Study

Dr. Ovidiu Andronesi, MD, PhD, an Associate Professor of Radiology at Harvard University and Director of Multinuclear Metabolic Imaging at the Martinos Center for Biomedical Imaging, Massachusetts General Hospital, has been appointed as the principal investigator. Dr. Andronesi brings significant expertise to the study, which seeks to evaluate the effects of AL001 on PTSD.

Investigating Lithium’s Potential for PTSD Treatment

Lithium, the first mood stabilizer approved by the U.S. Food and Drug Administration (FDA), remains a key treatment option for bipolar disorder. Despite its longstanding use and well-characterized safety profile, lithium does not currently have an FDA-approved indication for PTSD. However, case reports suggest that lithium may offer benefits for PTSD patients, particularly in low doses (300–600 mg/day) to address symptoms such as inappropriate anger, irritability, anxiety, and insomnia. The new study will explore the comparative effectiveness of AL001, a novel lithium-delivery system, by assessing lithium levels in the brain and its structures in PTSD patients. This research aims to predict the minimum effective dose of AL001, potentially improving upon traditional lithium salts.

Key Objectives and Study Goals

The primary objective of this Phase II trial is to compare lithium levels in the brain with those achieved using commonly marketed lithium salts. By investigating how AL001 affects brain lithium concentrations, Alzamend hopes to establish a dosing regimen that matches the effectiveness and safety of existing lithium treatments while avoiding the narrow therapeutic window and associated monitoring requirements.

Alzamend’s Previous Success and Future Prospects

Alzamend previously completed a Phase IIA trial, identifying a maximum tolerated dose (MTD) for AL001. This dose, equivalent to 240 mg of lithium carbonate administered three times daily, is designed to avoid the need for routine therapeutic drug monitoring (TDM). Traditional lithium salts, including carbonate and citrate, require regular TDM due to their narrow therapeutic index and potential for chronic toxicity. Alzamend’s AL001 aims to address these issues by offering improved safety and brain bioavailability.

CEO Statement and Study Outlook

Stephan Jackman, CEO of Alzamend, expressed enthusiasm about the partnership with Massachusetts General Hospital and Dr. Andronesi. “We are elated to collaborate on this pivotal study for AL001,” said Jackman. “If we can develop a next-generation lithium product with a better safety profile and enhanced biodistribution, it would represent a significant advancement over current treatments and benefit the over 9 million Americans affected by PTSD.”

About AL001 and Alzamend Neuro

AL001 is a novel lithium-delivery system designed to mitigate toxicities associated with traditional lithium treatments while providing effective mood stabilization. Alzamend Neuro’s pipeline includes AL001 and ALZN002, a cell-based therapeutic vaccine for Alzheimer’s disease. Both candidates are licensed from the University of South Florida Research Foundation under exclusive worldwide licenses.

Forward-Looking Statements

This press release contains forward-looking statements within the meanings of relevant securities laws. These statements involve risks and uncertainties that may cause actual results to differ. Alzamend Neuro undertakes no obligation to update these statements publicly. For more information on potential risks, please refer to Alzamend’s filings with the U.S. Securities and Exchange Commission, available at www.sec.gov and on Alzamend’s website at www.Alzamend.com.

FAQ