Next-Gen Bipolar Disorder Treatment Progressing, Says Alzamend
Clinical stage biopharmaceutical company, Alzamend Neuro (Nasdaq: ALZN), has received a “Study May Proceed” letter from the FDA for a Phase IIA clinical study of AL001 for Bipolar Disorder (BD) type 1.
Alzamend previously completed a Phase IIA study of AL001 as a treatment for Alzheimer’s disease and identified a candidate dose that is unlikely to require therapeutic drug monitoring (TDM).
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 BD. We are advancing the process and expect that the first patient will be dosed in the first quarter of 2024.”
Highlights
Through study AL001-BD01, a Phase IIA clinical study of AL001 for BD, Alzamend aims to develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring. This would constitute a major improvement over current lithium-based treatments.
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.
Safety aspects of AL001 development may qualify for a Section (505)(b)(2) NDA pathway in support of FDA approval.
Bipolar disorder, previously known as manic depression, is a mood disorder characterized by periods of depression and periods of abnormally elevated happiness that last from days to weeks each.
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, proline and salicylate, and AL002 – 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.
