On Tuesday, Alzamend Neuro, Inc. ALZN announced its plans to initiate a phase 2 clinical study of AL001 for patients with post-traumatic stress disorder (PTSD) in the fourth quarter of 2025.
The study follows Tesla Dynamic Coils BV's completion of a head coil, a key component of the clinical trial.
In collaboration with Massachusetts General Hospital as its contract research organization, Alzamend aims to explore the properties of AL001 and its effects on lithium delivery in the brain compared to marketed lithium salts.
The study could illuminate the path forward in patients with PTSD by demonstrating AL001's targeted effectiveness and reduced systemic side effects.
Previous studies in mice have shown that AL001 ensures better brain absorption while maintaining lower levels of lithium in the blood, paving the way for safer and more efficient treatments.
The company says that although lithium does not have an FDA-approved indication for PTSD, case reports suggest that lithium treatment may be useful for treating PTSD patients.
Treatment with low doses (300–600 mg/day) of lithium carbonate has been reported to provide effective treatment in the reduction of inappropriate anger, irritability, anxiety, and insomnia in those patients.
The clinical observation of mood swings beyond the normal range but milder than those associated with bipolar disorder reportedly suggested the presence of a sub-threshold mood disorder in these PTSD patients.
It has also been proposed that treatment of trauma with lithium to forestall the development of PTSD may be provided by pharmacological induction of mild transient amnesia.
In March, Alzamend Neuro announced its plans to initiate a phase 2 clinical study of AL001 for bipolar disorder, which is expected to commence in the third quarter of 2025.
Price Action: ALZN stock is up 2.99% at $0.73 during the premarket session at the last check Tuesday.
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