Benzinga | Sep 30, 2021 10:12AM EDT

Alzamend Neuro Receives Pre-IND Response from FDA for AL002, a Cell-Based Therapeutic Vaccine That Seeks to Restore the Ability of Patients' Immunological System to Combat Alzheimer's Disease

FDA Agrees to Alzamend's Plan to Conduct a Combined Phase 1 and 2 Clinical Trial for AL002

Alzamend Neuro, Inc. (NASDAQ:ALZN) ("Alzamend"), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that it has received a written response to its meeting request relating to its Type B PreInvestigational New Drug ("IND") application from the U.S. Food and Drug Administration (the "FDA") providing a path for Alzamend's planned clinical development of AL002. AL002 is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient's immunological system to combat Alzheimer's.

"We appreciate the thorough and meaningful response from the FDA, which provides us with the information and clarity needed to submit the IND application to initiate a clinical trial for AL002," said Stephan Jackman, Alzamend's Chief Executive Officer. "Preclinical work supports AL002 being associated with a positive anti-inflammatory response and a decrease in brain amyloid contents. Based on AL002's positive toxicology results, the biologic nature of this product and the urgent need to deliver treatments for Alzheimer's to patients, Alzamend proposed, and the FDA agreed, to conduct a combined Phase 1/2 study. We appreciate the FDA's recommendations, guidance and other helpful advice. We plan to augment our proposed clinical trial protocols and proceed accordingly."

Based on the FDA's written feedback, Alzamend anticipates filing the IND by the end of November 2021 and initiating the clinical trial of AL002 in the first quarter of 2022.