Lithium Therapeutic Drug Candidate for PTSD Proceeds in Phase IIA Clinical Trial

Alzamend Neuro, Inc. today announced receipt of a "Study May Proceed" letter from the U.S. Food and Drug Administration ("FDA") for the initiation of study AL001-PTSD01, a Phase IIA clinical study of AL001 for the treatment of patients with post-traumatic stress disorder ("PTSD").

AL001 is a novel lithium-delivery system that can potentially deliver the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium.

"Although lithium does not have an FDA-approved indication for PTSD, it has been prescribed off-label for this purpose for decades," said Stephan Jackman, Chief Executive Officer of Alzamend, in a press release on December 11, 2023.

"If we can develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring, it would constitute a major improvement over current lithium-based treatments and positively impact the 9 million Americans afflicted with PTSD."

"We are advancing the process and expect that the first patient will be dosed in the first quarter of 2024."

AL001 is designed to favorably distribute lithium in the brain resulting in lower exposure to other body organs and an improved safety profile compared to currently marketed lithium salts.

This can serve to mitigate or obviate the disadvantageously low ceiling for toxicity of marketed lithium salts that have limited their usefulness to patients and prescribers.

PTSD is a mental and behavioral disorder that can develop because of exposure to a traumatic event, such as sexual assault, warfare, traffic collisions, child abuse, domestic violence, or other threats to a person's life.

According to the U.S. NIH, about 3.6% of adults in the U.S. have PTSD in a given year, and 9% of people develop it at some point in their life. Worldwide, rates for PTSG in a given year are between 0.5% and 1% of the population.