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Alzamend Neuro Reports Positive Topline Data from Phase II Clinical Trial of AL001 "Lithium in Brain" Study; AL001 Achieves Bioequivalence and Demonstrates Superior Brain Delivery Across All Measured Brain Regions
Bioequivalence Confirmed: AL001 delivered 101% of total lithium blood exposure and 97% of peak lithium levels vs. standard lithium carbonateSuperior Brain
About this update from Alzamend Neuro, Inc.
[{"type":"text","content":"Bioequivalence Confirmed: AL001 delivered 101% of total lithium blood exposure and 97% of peak lithium levels vs. standard lithium carbonateSuperior Brain Penetration: AL001 showed numerically higher lithium concentrations in all measured brain regions, including whole brainFaster Brain Uptake: AL001 reached peak brain concentration in 6.7 hours vs. 8.4 hours for standard lithium carbonateATLANTA, March 26, 2026 /PRNewswire/ -- 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 type 1 (\"BD\"), major depressive disorder (\"MDD\") and post-traumatic stress disorder (\"PTSD\"), today announced positive topline data from its first Phase II \"Lithium in Brain\" clinical trial in healthy human subjects, demonstrating that AL001 meets bioequivalence standards while also showing numerically superior lithium delivery to the brain compared to standard lithium carbonate across all 26 measured brain regions including whole brain. These results suggest a promising differentiated pharmacological profile with significant implications for patients with Alzheimer's, BD, MDD and PTSD. The trial was conducted at Massachusetts General Hospital (\"MGH\") and represents a meaningful clinical and regulatory advance for AL001.\n \n \n \n \n \n \n \nPhase II Topline ResultsAL001 Achieves Bioequivalence with Standard Lithium Carbonate:The U.S. Food and Drug Administration (the \"FDA\") requires a new formulation to deliver between 80% to 125% of the reference drug to the bloodstream to support equivalent systemic safety. AL001 delivered 101% of total lithium exposure and 97% of peak lithium levels compared to standard lithium carbonate, which are both squarely within the required FDA range. Achieving bioequivalence supports a Section 505(b)2 new drug application submission for safety, potentially mitigating non-clinical requirements.Superior Brain Penetration Across all 26 Measured Regions, Including Whole Brain:Using a one-of-a-kind Tesla head coil that provides advanced magnetic resonance imaging (\"MRI\") and magnetic resonance spectroscopy (\"MRS\") neuroimaging, researchers quantified lithium in 25 discrete brain regions as well as the whole brain. AL001 showed numerically higher lithium conce...