Head-to-head studies of AL001 versus a marketed lithium carbonate product will be conducted for comparisons of lithium blood and brain/brain-structure pharmacokinetics in healthy, Alzheimer’s disease, BD, MDD, and PTSD subjects
Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced the completion of a groundbreaking head coil by Tesla Dynamic Coils BV (“Tesla”). The development of the head coil was necessary to facilitate the five upcoming Phase II clinical trials to be conducted by Alzamend.
In collaboration with Massachusetts General Hospital as its contract research organization, Alzamend intends to undertake pioneering clinical trials, with a goal to assess how lithium levels in the brain differ when using AL001 compared to marketed lithium salts, both in healthy individuals and patients with Alzheimer’s, BD, MDD and PTSD. The one-of-a-kind engineered head coil will enable whole-brain imaging of lithium with remarkable resolution, allowing precise quantification within brain structures. The coil will be used to help identify the disease-specific target doses of AL001 that improve the balance of safety and efficacy compared to lithium carbonate. The coil will also be used to scan the entire brain, helping us clearly identify the different structures and important areas necessary for understanding how lithium works and moves within the brain.
These studies are expected to provide greater clarity on how lithium treatments reach the brain, showcasing AL001’s superior ability to target brain structures while reducing systemic exposures. Nonclinical (mouse) studies have already demonstrated that AL001 optimizes brain absorption with lower blood concentration levels when compared to lithium carbonate, suggesting promising human applications. This cutting-edge approach ensures that lithium via AL001 remains effective in the brain with significantly reduced risks of harmful side effects on the kidneys and thyroid. By enabling safer dosing, expanding the therapeutic index, and potentially removing the need for lithium therapeutic drug monitoring (“TDM”), AL001 represents a potential groundbreaking advance. These innovations could deliver more effective and secure treatments to vulnerable groups, such as Alzheimer’s patients, highlighting AL001’s potential in improving patient care and treatment efficacy.
“We want to thank Tesla for working with us to create this one-of-a-kind lithium head coil,” stated Stephan Jackman, Chief Executive Officer of Alzamend. “The development of the coil was a long time coming, but we believe the time and effort was necessary to allow us unprecedented knowledge as to how lithium interacts within our brains. We believe that our upcoming studies, utilizing the head coil, has the potential to broaden the application of lithium treatment across numerous neurodegenerative diseases and psychiatric disorders. Its completion allows us to solidify our timeline for the forthcoming clinical trials in collaboration with Massachusetts General Hospital. We look forward to sharing additional details regarding these trials soon.”
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