Alzamend Neuro (ALZN) Receives FDA “Study May Proceed” Letter for Phase 1 Clinical Study Under Its Investigational New Drug Application for AL001 for Dementia Related to Alzheimer’s Disease

Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced receipt of U.S. Food and Drug Administration (“FDA”) study may proceed letter for a Phase 1 study under the Company’s Investigational New Drug application for AL001, a lithium-based ionic cocrystal oral therapy for patients with dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimer’s disease.

“We are grateful to receive this timely, favorable response from the FDA to initiate a Phase 1 trial with AL001,” said Stephan Jackman, the Chief Executive Officer of Alzamend. “We are advancing the process and expect that the first patient will be dosed in September 2021.”

About AL001

AL001 is a patented ionic cocrystal technology delivering a therapeutic combination of lithium, proline and salicylate, known as AL001 or LiProSal, through two royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc.

Based 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.

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