Alzamend Neuro completes clinical portion of Phase II clinical study of AL001

Alzamend Neuro (ALZN) announced completion of the clinical portion of its first Phase II clinical study of AL001, in healthy human subjects. In collaboration with Massachusetts General Hospital as the clinical trial site, Alzamend is investigating the distinctive characteristics of AL001. The primary objective is to assess how AL001 delivers lithium to the brain compared to marketed lithium salts, evaluating its ability to achieve better therapeutic efficacy while minimizing systemic side effects. This clinical study utilized a unique, engineered head coil developed by Tesla Dynamic Coils BV. This one-of-a-kind technology grants the capability for high-resolution, whole-brain lithium imaging, which allows for the precise quantification of lithium within specific brain structures. The resulting proprietary imaging data sets will be used to establish a foundational reference, helping Alzamend accurately identify the optimal, disease-specific target doses of AL001. These findings will inform the planned Phase II clinical trials in Alzheimer’s, BD, MDD, and PTSD, which are all expected to be initiated next year, and confirm that AL001 offers a superior balance of safety and efficacy compared to conventional lithium carbonate. By potentially removing the requirement for lithium therapeutic drug monitoring, or TDM, AL001 could transform treatment for at-risk patient groups and enhance clinical outcomes. Lithium is widely recognized as a highly effective first-line option for managing manic episodes and maintenance in BD, yet its adoption has been limited by TDM challenges. Lithium salts approved by the FDA currently face a narrow therapeutic index, necessitating frequent clinician-monitored plasma lithium and blood chemistry tests to prevent adverse effects.