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Alzamend Neuro Submits IND Application for AL001 for Dementia Related to Alzheimer’s Disease
TAMPA, Fla.--(BUSINESS WIRE)-- Alzamend Neuro®, Inc. (Nasdaq: ALZN) (“Alzamend”), a preclinical stage biopharmaceutical company, today announced that it
About this update from Alzamend Neuro, Inc.
[{"type":"text","content":" TAMPA, Fla.--(BUSINESS WIRE)--\nAlzamend Neuro®, Inc. (Nasdaq: ALZN) (“Alzamend”), a preclinical stage biopharmaceutical company, today announced that it submitted an investigational new drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for the initiation of a Phase 1 clinical study of AL001 on June 30, 2021. The Phase 1, first-in-human study is for the purpose of determining potential clinically safe and appropriate AL001 dosing in future studies. AL001 is a lithium-based ionic cocrystal oral therapy for patients with dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimer’s disease.\n\nFollowing completion of this initial study, Alzamend intends to initiate a Phase 1/2a clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AL001 in Alzheimer’s disease patients. Presuming favorable data, a subsequent Phase 2b program is planned to target appropriate doses for the pivotal Phase 3 safety/efficacy clinical program required for regulatory approval.\n\n“This IND submission represents a key milestone for Alzamend as we continue to advance our proprietary pipeline. We believe AL001 could potentially provide clinicians with a major improvement over current lithium-based treatments and may constitute a means of treating Alzheimer’s disease and other neurodegenerative diseases and psychiatric disorders. We look forward to providing more details on the timeline and market opportunity following FDA clearance of the IND, if obtained,” commented Stephan Jackman, Chief Executive Officer of Alzamend.\n\nBased on preclinical data, AL001 treatment prevents cognitive deficits, depression, and irritability in APPSWE/PS1dE9 mice, and has shown an improvement of associative learning and memory and irritability compared with lithium carbonate treatments, supporting the potential of this lithium formulation for the treatment of Alzheimer’s disease and psychiatric disorders. Lithium has been marketed for more than 35 years and human toxicology regarding lithium use has been well characterized, potentially allowing Alzamend to rely upon this existing data, potentially reducing the regulatory burden for safety data.\n\nAlzamend’s mission is to help the Alzheimer’s disease community by supporting the full product developme...