#United States #Atlanta #Alzamend Neuro #AL001 #Lithium Therapy

Alzamend Neuro Completes Phase II Clinical Portion of AL001 Trial

Alzamend Neuro, Inc., a clinical-stage biopharmaceutical company focusing on innovative products for mental health conditions, has announced the successful completion of the clinical phase of its first Phase II trial for AL001, a novel lithium delivery system. Conducted at the prestigious Massachusetts General Hospital, the clinical trial aimed to explore the unique properties of AL001, comparing its effectiveness in delivering lithium to the brain versus that of conventional lithium salts.

Study Overview

The primary objective of this trial was to evaluate how effectively AL001 transports lithium into the brain, analyzing pharmacokinetics in healthy subjects. The study employed a distinctive head coil designed by Tesla Dynamic Coils BV. This advanced imaging technology enabled researchers to perform high-resolution, whole-brain lithium imaging, making it possible to quantify lithium distribution within specific brain areas accurately. The proprietary data generated aims to establish a reference for determining optimal dosing targets tailored to different diseases, laying groundwork for future clinical trials in conditions such as Alzheimer’s disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder, which are set to begin next year.

Transformative Potential of AL001

The innovative formulation of AL001 is designed to potentially mitigate systemic side effects, ensuring a superior safety profile compared to conventional lithium carbonate products. Previous studies indicated that AL001 facilitates higher brain lithium uptake while maintaining lower blood lithium levels. This aspect could revolutionize treatment protocols, particularly for at-risk patient populations, by reducing the dependency on therapeutic drug monitoring (TDM), a commonly required practice in traditional lithium treatments.

Lithium has long been acknowledged as a first-line treatment for manic episodes in bipolar disorder; however, its application has often been limited due to the challenges posed by TDM. With its narrow therapeutic index, traditional lithium salts necessitate frequent monitoring to prevent adverse side effects, complicating their use. Alzamend’s AL001 formulation promises a paradigm shift by reducing systemic exposure to lithium, thereby lowering risks of kidney and thyroid complications typically associated with conventional lithium therapies.

Insights from Leadership

Stephan Jackman, the Chief Executive Officer of Alzamend, expressed enthusiasm regarding the completion of the clinical part of this Phase II trial, stating, "This significant milestone underscores our commitment to developing a next-generation lithium therapy characterized by improved safety and enhanced brain penetration without the need for TDM." He further acknowledged the vital contributions of patients and investigators in bringing this study to fruition, expressing gratitude for their commitment.

Topline results from this trial are anticipated to be reported in the first quarter of 2026, marking a significant step forward in Alzamend’s ongoing development of this promising therapeutic candidate.

About AL001 and Alzamend Neuro

AL001 is a uniquely patented lithium delivery system conceived to provide the therapeutic advantages of marketed lithium products while avoiding the toxicities associated with traditional lithium therapies. The completed Phase IIA study established a maximum tolerated dose, enabling treatment without necessitating extensive monitoring while ensuring adequate lithium exposure for effectiveness.

Additionally, Alzamend Neuro is actively pursuing another candidate, ALZN002, designed to harness the body’s immune system against Alzheimer’s by removing beta-amyloid plaques from the brain. This seeks to offer a second-generation, more effective approach to immunity in Alzheimer’s treatment.

The innovative research and developments spearheaded by Alzamend hold the promise of redefined treatment protocols for mental health disorders, aiming to deliver safer, more effective options for patients desperately seeking relief from their conditions.