Alzamend Neuro, Inc. (Nasdaq: ALZN), a clinical-stage biopharmaceutical company, today announced it will present a poster at the Society of Toxicology (SOT) Annual Meeting and ToxExpo, which will be held from March 16-20, 2025, in Orlando, Florida. The poster will highlight non-clinical data comparing brain and plasma lithium exposures between AL001 and lithium carbonate in Alzheimer’s transgenic mice. This study demonstrates AL001’s potential to enhance brain-specific lithium delivery while minimizing systemic exposure in an Alzheimer’s mouse model, guiding the development of safer and more effective lithium therapies for human diseases.
Stephan Jackman, CEO of Alzamend, emphasized, “Our study data supports AL001’s potential to improve lithium therapy, offering enhanced brain penetration and reduced systemic exposure, which could revolutionize the treatment of Alzheimer’s and other neurodegenerative and neuropsychiatric disorders.” He added that after successful Phase I and IIA trials, AL001 is poised for five Phase II trials in 2025, in collaboration with Massachusetts General Hospital. These trials are expected to position AL001 for approval through the U.S. Food and Drug Administration’s 505(b)(2) pathway.
The poster presentation, titled Pharmacokinetics of AL001, Lithium Salicylate/L-Proline Co-crystal: A Potentially Beneficial Lithium Sparing Treatment for Bipolar Disorder Type 1 (BD1), Alzheimer’s Disease (AD), Major Depressive Disorder (MDD) and Post-traumatic Stress Disorder (PTSD), will take place on Monday, March 17, 2025, from 9:15 AM to 11:45 AM ET at the Orange County Convention Center, ToxExpo Hall. Dr. Darrell Sawmiller, Assistant Professor at the Center of Excellence for Aging & Brain Repair at the University of South Florida, will present the data.
The study, which compared AL001 to lithium carbonate in 5XFAD mice—a well-established Alzheimer’s model—showed that AL001 had lower plasma lithium levels, indicating reduced risk of adverse systemic effects. Moreover, AL001 demonstrated superior brain penetration, particularly at lower doses, allowing for more targeted treatment of brain structures, an important feature for conditions like Alzheimer’s, bipolar disorder, and PTSD. These results suggest that AL001 could provide a safer, more effective treatment option by reducing the systemic burden often associated with traditional lithium therapies.
The study positions AL001 as a promising candidate for long-term treatments, potentially eliminating the need for routine blood lithium monitoring, which is crucial for fragile populations such as elderly and Alzheimer’s patients. By minimizing risks like thyroid and kidney complications, AL001 offers a safer alternative to current therapies.
Alzamend Neuro focuses on developing novel treatments for Alzheimer’s, bipolar disorder, major depressive disorder, and PTSD. Its pipeline includes AL001, a patented lithium-based drug, and ALZN002, a cell-based vaccine for Alzheimer’s, both licensed from the University of South Florida Research Foundation.
