ALZN News & Events

Alzamend Neuro announced "encouraging" pharmacodynamic findings from a brain magnetic resonance spectroscopy, or MRS, analysis conducted in six healthy human subjects in a trial conducted at Massachusetts General Hospital. The study assessed changes in five key brain metabolites across 18 brain regions when participants received two-weeks of blood bioequivalent and lithium-dose equivalent AL001 or lithium carbonate relative to baseline. Early data suggest AL001 may work like lithium carbonate by selectively impacting brain chemicals where needed, however, AL001 appears to be leaving other, healthy brain chemicals more undisturbed than lithium carbonate, a potentially meaningful tolerability advantage. These interpretations need to be further statistically confirmed in additional patient populations, the first of which is currently underway. When participants took AL001, multiple brain chemicals trended downward, while the same chemicals trended upward in those same participants when they took lithium carbonate. Keeping glutamate stable is important for long-term brain health, which suggests AL001 may have fewer side effects than lithium carbonate over time, however, this needs confirmation over a longer duration of exposure. Alzamend has identified pharmacodynamic hypotheses to be tested in future confirmatory studies involving subjects with Alzheimer's, BD, MDD and PTSD. Unlike lithium carbonate, AL001 may help preserve the health of brain cell membranes in healthy tissue, the protective outer layer of brain cells that play a critical role in how they function and communicate.

Alzamend Neuro 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 and represents a meaningful clinical and regulatory advance for AL001. Bioequivalence Confirmed: AL001 delivered 101% of total lithium blood exposure and 97% of peak lithium levels vs. standard lithium carbonate. Superior Brain Penetration: AL001 showed numerically higher lithium concentrations in all measured brain regions, including whole brain. Faster Brain Uptake: AL001 reached peak brain concentration in 6.7 hours vs. 8.4 hours for standard lithium carbonate.

Alzamend Neuro announced the initiation of its Phase II clinical trial evaluating AL001 in patients diagnosed with BD type 1. The trial is being conducted at Massachusetts General Hospital and represents a significant step toward advancement of AL001 as a potentially safer and more effective lithium-based therapy. This Phase II study builds upon Alzamend's prior "Lithium in Brain" clinical trial in healthy subjects, for which the clinical portion was completed in November 2025. Topline data from that study are expected by the end of March 2026. Following completion in healthy volunteers, Alzamend and MGH are now expanding the program to subjects with BD type I, with plans to also initiate further trials in the near future in MDD, Alzheimer's and PTSD.

Alzamend Neuro will have a poster presentation at the Military Health System Research Symposium, being held from August 4-7, 2025, in Orlando, Florida. Title: Quantitate Differences in Lithium Brain-to-Plasma Exposure in PTSD Subjects Between AL001 and Lithium Carbonate: Summary: The current study is designed to quantitate differences in lithium brain-to-plasma exposure in PTSD subjects between AL001 and lithium carbonate for the purpose of contributing to a composite database of analogously studied brain-plasma assessments that include data from healthy subjects and multiple additional neurodegenerative, neurological and neuropsychiatric disorders. Currently, AL001 is targeted for treatment of Alzheimer's, BD type 1, MDD and PTSD. It's anticipated that this study design may help target appropriate AL001 lithium systemic dosing for these indications in future studies. Using this study design, comparable target organ lithium concentrations may be quantitated between AL001 and lithium carbonate and, by equivalence inference, lithium citrate solution and syrup.