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
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.
Although lithium products do not have an FDA-approved indication for PTSD, case reports suggest that lithium treatment may be useful for treating PTSD patients. Specifically, treatment with low doses (300-600 mg/day) of lithium carbonate have been reported to provide effective treatment in reduction of inappropriate anger, irritability, anxiety, and insomnia in patients with PTSD. Alzamend s goal is to revive the utility of lithium treatment by importantly improving the benefit-to-risk relationship of lithium treatment in clinical practice. Based on the favorable AL001 safety profile observed in the recently completed study and extensive safety data on the drug s constituent components, the AL001 development program may qualify for a Section 505(b)(2) New Drug Application ( NDA ) pathway for FDA approval, which is available to new formulations of an approved drug.
About Post-Traumatic Stress Disorder
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 on a person s life (American Psychiatric Association DSM-5-TR, 2020;
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as believes, plans, anticipates, projects, estimates, expects, intends, strategy, future, opportunity, may, will, should, could, potential, or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend s business and financial results are included in Alzamend s filings with the
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