Alzamend Neuro Receives FDA “Study May Proceed” Notification for a Phase IIA Clinical Trial of AL001, a Next‑Generation Lithium Therapeutic Drug Candidate, in Post-Traumatic Stress Disorder Patients

Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), 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 treatment of patients with PTSD.

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“We are grateful to receive this timely, favorable response from the FDA to initiate our first Phase IIA clinical study of AL001 for PTSD. 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. “If we can develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring ('TDM'), 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. We have now received ‘Study May Proceed’ letters from the FDA during the last three months for Phase IIA clinical studies of AL001 for treatment of patients with BD, MDD and PTSD.”

About AL001

AL001 is a novel lithium-delivery system that has the potential to deliver benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. Results from Alzamend’s recently completed Phase IIA multiple-ascending dose study of AL001 in Alzheimer’s patients and healthy subjects identified a maximum tolerated dose (“MTD”), as assessed by an independent safety review committee. This MTD is designed to be unlikely to require TDM while providing lithium at a relatively modest but effective dose. AL001 is designed to favorably distribute lithium in brain resulting in lower exposure of 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 has limited their usefulness to patients and prescribers.