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Alzamend Neuro Announces Full Data Set from its Nonclinical Study: Comparing Brain and Plasma Lithium Exposures between AL001 and Lithium Carbonate in Alzheimer’s Transgenic Mice
Alzamend is developing AL001, a lithium product designed for enhanced safety and efficacy compared to currently available FDA-approved and marketed lithium
About this update from Alzamend Neuro, Inc.
[{"type":"text","content":"\n\nAlzamend is developing AL001, a lithium product designed for enhanced safety and efficacy compared to currently available FDA-approved and marketed lithium therapies\n\n\n\nAt a low dose, AL001 evidenced consistently higher lithium concentrations than lithium carbonate within critical brain regions comprising target tissue for efficacy, which may provide therapeutic benefits with less risk in multiple neurological disorders\n\n\n\nData will guide upcoming “Lithium in Brain” Phase II clinical trials in partnership with Massachusetts General Hospital\n\n\n\n ATLANTA--(BUSINESS WIRE)--\nAlzamend 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 that it has finished analyzing the final full data set from a nonclinical study comparing brain and plasma lithium exposures between AL001 and lithium carbonate in Alzheimer’s transgenic mice. The study was conducted at the University of South Florida and the bioanalytical procedures for determination of lithium concentration in the brain and plasma samples were conducted under good laboratory practice standards by Sannova Analytical LLC.\n\n\nThe study involved administering AL001, a good manufacturing practices-quality active pharmaceutical ingredient (“API”) to 5XFAD mice, a recognized model for Alzheimer’s research, to compare its effects against lithium carbonate, a U.S. Food and Drug Administration (“FDA”) approved and marketed API. Mice received either high or low doses scaled to humans of both AL001 and lithium carbonate over a 14-day period to observe pharmacokinetic steady-state drug conditions. On the 15th day, the mice were analyzed to assess how the treatments affected lithium concentrations in different brain regions and in their plasma.\n\n\nKey Findings:\n\n\n\nNo Undue Adverse Effects: Both treatments had no negative impact on the mice's body weight or clinical signs during the treatment period.\n\n\n\nReduced Systemic Exposure: AL001 showed lower plasma lithium levels than lithium carbonate, reducing the risk of adverse systemic effects, suggesting an expansion for safety of lithium’s therapeutic index.\n\n\n\nEnhanced Brain ...