FDA Says Alzamend Neuro Major Depressive Disorder Study May Proceed
Alzamend Neuro, Inc. (Nasdaq: ALZN) has received a “Study May Proceed” letter from the FDA for the initiation of study AL001-MDD01, a Phase 2a clinical study of AL001 for treatment of patients with major depressive disorder (MDD). AL001 is the company’s 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. Alzamend expects the first patient in the study to be dosed in the first quarter of 2024.
Stephan Jackman, Chief Executive Officer of Alzamend, said, “We are grateful to receive this timely, favorable response from the FDA to initiate our first Phase IIA clinical study of AL001 for 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 we 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.”
Highlights
Safety aspects of AL001 development may qualify for a 505(b)(2) NDA pathway for FDA approval.
Alzamend’s recently completed Phase IIA study of AL001 in Alzheimer’s patients and healthy subjects showed a benign safety profile and identified a candidate dose that is unlikely to require therapeutic drug monitoring.
Lithium is one of the few agents that has demonstrated efficacy as a treatment for major depressive disorder (MDD) 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.
MDD, or 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.
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.
