Phase II Trial of AL001 for MDD Set to Begin Later this Year
Alzamend Neuro Inc., Atlanta, Georgia, has announced plans for a phase II clinical study of the investigational lithium therapy AL001 in patients with major depressive disorder (MDD). The head-to-head trial of AL001 with a lithium carbonate product currently on the market is scheduled to begin in the fourth quarter of 2025 at Massachusetts General Hospital, Boston, Massachusetts.
The study aims to investigate the unique properties of AL001 and its effect on lithium delivery in the brain compared with marketed lithium salts. Studies in mice have found better brain absorption with AL001 and reduced levels of lithium in the blood.
“With AL001, we can potentially introduce a next-generation lithium treatment that offers enhanced safety, better brain targeting, and no need for TDM [therapeutic drug monitoring], promising a leap forward from the current, burdensome options,” said Alzamend Neuro chief executive officer Stephan Jackman.
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Current lithium salts (carbonate and citrate) approved by the US Food and Drug Administration are limited by a narrow therapeutic window that requires monitoring of plasma lithium levels and blood chemistry to reduce adverse events, the company explained. AL001 is a novel lithium-delivery system that aims to provide the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. AL001 is designed to favorably distribute lithium in the brain, resulting in lower exposure to other body organs and an improved safety profile.
Although lithium is not approved for antidepressant augmentation in patients with MDD, it is often prescribed off-label and has demonstrated efficacy in randomized controlled trials, Alzamend Neuro explained in the news release.
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