Alzamend Neuro Submits IND Application for Study in Major Depressive Disorder

Biopharmaceutical company, Alzamend Neuro (Nasdaq: ALZN) has submitted an investigational new drug application to the FDA for the initiation of a Phase IIA clinical study of AL001 for adjunctive treatment of patients with Major Depressive Disorder (MDD). AL001 is a novel lithium-delivery system that has the potential to provide benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium.

280 million people worldwide are currently living with MDD.

Stephan Jackman, Chief Executive Officer of Alzamend, “This IND submission represents the next key milestone for Alzamend as we further advance our proprietary pipeline. We look forward to providing more details regarding the study’s timeline and market opportunity in the near future.”

Highlights

Alzamend’s recently completed Phase IIA multiple-ascending dose study of AL001 in Alzheimer’s patients and healthy subjects identified a maximum tolerated dose (MTD) which is designed to distribute more lithium to the brain but at lower systemic exposure, resulting in an improved safety profile compared to currently marketed lithium salts.

The company anticipates that its program may qualify for a 505(b)(2) NDA pathway to FDA approval, which is available to new formulations of an approved drug.

MDD, also known simply as depression, is a mental disorder characterized by at least two weeks of pervasive low mood, low self-esteem, and loss of interest or pleasure in normally enjoyable activities.

The disorder is believed to be caused by a combination of genetic, environmental, and psychological factors, with about 40% of the risk being genetic.

About Alzamend Neuro

Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s, BD, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 – a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, salicylate and L-proline, 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.