Making Alzheimer’s Just a Memory™
Our mission is to rapidly develop and market safe and effective treatments. We are driven by the belief that strong support of research is the foundation for true innovation and uniquely position us to understand and effectively address the unmet needs of the patients we serve.
Alzamend Neuro® , Inc., (“Alzamend® ”), a Delaware corporation with its headquarters in Atlanta, Georgia, is a clinical-stage, biopharmaceutical company. At Alzamend, we are committed to “Making Alzheimer’s Just a Memory™ ” as well as developing effective treatments for psychiatric disorders which effect over 600 million people globally. Our mission is to rapidly develop and market safe and effective treatments. We are driven by the belief that strong support of research is the foundation for true innovation and uniquely position us to understand and effectively address the unmet needs of the patients we serve. Alzamend strives to provide hope through the commercialization of existing patented intellectual properties and know-how while simultaneously funding future treatments for other neurodegenerative diseases and psychiatric disorders, through advanced research and development.
Our current pipeline consists of two novel therapeutic drug candidates, AL001 – a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, proline and salicylate, and ALZN002 – a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.
Our lead product candidate (AL001) that we have licensed and have begun clinical development in humans for the treatment of Alzheimer’s, bipolar disorder, MDD and PTSD. Based on our preclinical data, AL001 treatment prevents cognitive deficits, depression and irritability in APPSWE/PS1dE9 mice, and is superior in improving associative learning, memory, and irritability, compared with lithium carbonate treatments. Lithium has been marketed for more than 35 years and human toxicology regarding lithium use has been well characterized, potentially mitigating the regulatory burden for safety data.
ALZN002 is a proprietary “active” immunotherapy product, which means it is produced by each patient’s immune system. It consists of autologous dendritic cells (“DCs”), which are activated white blood cells taken from each individual patient that are then engineered outside of the body to attack Alzheimer’s-related amyloid-beta proteins. These DCs are pulsed with a novel amyloid-beta peptide (E22W) designed to bolster the ability of the patient’s immune system to combat Alzheimer’s; the goal of this treatment approach is to foster tolerance to treatment for safety purposes while stimulating the immune system to reduce the brain’s beta-amyloid protein burden, resulting in reduced Alzheimer’s signs and symptoms. In October 2022 we a “Study May Proceed” letter from the U.S. Food and Drug Administration (“FDA”) for a phase I/IIA clinical trial under its Investigational New Drug (“IND”) application for an immunotherapy (ALZN002) to treat mild to moderate dementia of the Alzheimer’s type. We aim to begin the trial in Q1 2023.
The Facts About Alzheimer's
Our primary target, Alzheimer’s disease, was among the most-feared diseases (second only to cancer) among Americans, according to a 2011 survey by the Harvard School of Public Health. Alzheimer’s is also the sixth leading cause of death in the United States according to a 2021 report from the Alzheimer’s Association, a nonprofit that funds research. Existing Alzheimer’s treatments only temporarily relieve symptoms but do not slow or halt the underlying worsening of the disease, which currently affects roughly 6.2 million Americans, and that number is expected to grow to 13 million individuals by 2050. Alzheimer’s also impacts more than 11 million Americans who provide an estimated 15.3 billion hours of unpaid care per year, valued at $257 billion, according to data provided by the Alzheimer’s Association. In 2021, the estimated healthcare costs for treating individuals with Alzheimer’s in the United States will be $355 billion, including $239 billion in Medicare and Medicaid payments. These costs could rise to as high as $1.1 trillion per year by 2050 if no permanent treatment or cure for Alzheimer’s is found, the Alzheimer’s Association reported.