Alzamend Neuro Offers Hope to 7 Million Americans with Bipolar Disorder
Alzamend Neuro (Nasdaq: ALZN) has submitted an investigational new drug (IND) application to the FDA for a Phase IIA clinical study of its lead candidate, AL001 for bipolar disorder (BD). 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.
Stephan Jackman, Chief Executive Officer of Alzamend, said, “This IND submission represents a key milestone for Alzamend as we continue to advance our proprietary pipeline. Being able to develop a next-generation lithium product that would not routinely require TDM (therapeutic drug monitoring) could positively impact the 7 million Americans afflicted with BD. We look forward to providing more details regarding the study’s timeline and market opportunity in the near future.”
Results from Alzamend’s recently completed Phase IIA multiple-ascending dose study of AL001 in Alzheimer’s and healthy patients identified a maximum tolerated dose (MTD), as assessed by an independent safety review committee.
This MTD, providing lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily, is designed to be unlikely to require therapeutic drug monitoring (TDM).
The gold standard treatment for BP is lithium, which is underutilized because of the need for TDM and the narrow treatment range that can result in toxicity at high doses and can impair effectiveness at low doses.
Once the IND is cleared by the FDA, Alzamend intends to initiate the Phase IIA study to determine relative increased lithium levels in the brain compared to a marketed lithium salt in BD patients, based on published mouse studies that predict that lithium can be given at lower doses for equivalent therapeutic benefit when treated with AL001.
Alzamend believes this program may qualify for the 505(b)(2) pathway for FDA approval.
BD is among the top 20 causes of disability worldwide. The risk of suicide is high and other mental health issues, such as anxiety disorders and substance use disorders, are commonly associated with BD.
About Alzamend Neuro
Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s, BPD, 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.