Pharma Focus Europe

Alzamend Neuro Granted FDA Authorization for Phase IIA Clinical Trial of AL001, an Innovative Lithium-based Therapeutic, in Bipolar Disorder Patients

Monday, October 02, 2023

Alzamend Neuro, Inc. (Nasdaq: ALZN) has received a positive response from the U.S. Food and Drug Administration (FDA) to proceed with their Phase IIA clinical study, designated as AL001-BD01, for Bipolar Disorder type 1. This clinical-stage biopharmaceutical company is dedicated to developing innovative treatments for Alzheimer's disease, Bipolar Disorder, Major Depressive Disorder, and Post-Traumatic Stress Disorder.

Stephan Jackman, Alzamend's Chief Executive Officer, expressed gratitude for the FDA's timely approval to initiate the Phase IIA study of AL001 for Bipolar Disorder type 1. He emphasized the significance of lithium as the first FDA-approved mood stabilizer, often considered the "gold standard" for Bipolar Disorder type 1 treatment. Alzamend's goal is to develop a next-generation lithium product, AL001, that can potentially eliminate the need for routine therapeutic drug monitoring, thus improving upon current lithium-based treatments. This advancement could greatly benefit the 7 million Americans affected by Bipolar Disorder type 1, with the first patient expected to receive treatment in the first quarter of 2024.

AL001 is an innovative lithium-delivery system designed to harness the therapeutic benefits of existing lithium salts while mitigating or avoiding the toxicities commonly associated with lithium treatment. A recent Phase IIA study by Alzamend in Alzheimer's patients and healthy subjects identified a maximum tolerated dose (MTD) for AL001. Importantly, this MTD is expected to provide effective lithium levels without the need for frequent therapeutic drug monitoring. AL001 is engineered to optimize the distribution of lithium in the brain, reducing exposure to other body organs and thereby improving safety compared to current lithium salts. This can address the limitations of existing lithium treatments, which often have a low threshold for toxicity, limiting their usefulness.

Lithium has a well-established track record of efficacy in treating Bipolar Disorder type 1. Alzamend aims to enhance the benefit-to-risk ratio of lithium treatment through AL001, leveraging the positive safety profile observed in recent studies and extensive safety data on its components. The AL001 development program may qualify for a Section 505(b)(2) New Drug Application (NDA) pathway for FDA approval, typically available for new formulations of approved drugs.

Bipolar Disorder, formerly known as manic depression, is a mood disorder characterized by alternating periods of depression and episodes of abnormally elevated mood or mania, each lasting from days to weeks. It is categorized as Bipolar Disorder type 1 if there has been at least one manic episode, with or without depressive episodes, and as Bipolar Disorder type 2 if there has been at least one hypomanic episode (but no full manic episodes) and one major depressive episode. In the United States, approximately 3% of the population is estimated to experience Bipolar Disorder at some point in their lives. This condition ranks among the top 20 causes of global disability and imposes significant societal costs. Individuals with Bipolar Disorder face a high risk of suicide, with 6% dying by suicide over a 20-year period and 30% to 40% engaging in self-harm. Additionally, other mental health issues such as anxiety disorders and substance use disorders are commonly associated with Bipolar Disorder.

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