Alzamend Neuro, Inc. announced receipt of a "Study May Proceed" letter from the U.S. Food and Drug Administration ("FDA") for the initiation of study AL001-MDD01, a Phase IIA clinical study of AL001 for treatment of patients with MDD. Although lithium does not have an FDA approved indication for augmentation of an antidepressant in MDD, it has been prescribed off-label for this purpose for decades. If can develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring ('TDM'), it would constitute a major improvement over current lithium-based treatments and positively impact the 21 million Americans afflicted with MDD.

About AL001 is a novel lithium-delivery system that has the potential to deliver benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. Results from 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"), as assessed by an independent safety review committee. This MTD is designed to be unlikely to require TDM while providing lithium at a relatively modest but effective dose.

AL001 is designed to favorably distribute lithium in brain resulting in lower exposure of other body organs and an improved safety profile compared to currently marketed lithium salts. This can serve to mitigate or obviate the advantageously low ceiling for toxicity of marketed lithium salts that has limited their usefulness to patients and prescribers. While a wide variety of medications have been used historically for augmentation of an antidepressants in MDD, lithium is one of the few agents that has demonstrated efficacy in multiple randomized controlled trials.

Alzamend's goal is to revive the utility of lithium treatment by importantly improving the benefit-to-risk relationship of lithium treatment in clinical practice. Based on the favorable AL001 safety profile observed in the recently completed study and extensive safety data on the drug's constituent components, the AL001 development program may qualify for a Section 505(b)(2) New Drug Application ("NDA") pathway for 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.

Those affected may also occasionally have delusions or hallucinations. Introduced by a group of U.S. clinicians in the mid- 1970s, the term was adopted by the American Psychiatric Association for this symptom cluster under mood disorders in the 1980 version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-III) and has become widely used since. It can negatively affect a person's personal life, work, or education as well as sleeping, eating habits, and general health.

According to the World Health Organization, approximately 280 million people (3.8% of the world's population) in the world suffer from MDD.