TAMPA, Fla.– 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 confirmation that topline data for its Phase 1 clinical trial for AL001 for dementia related to Alzheimer’s will be delivered mid- to late-December 2021. The Phase 1 first-in-human study is for the purpose of determining potential clinically safe and appropriate dosing for AL001 in a planned Phase 2 multiple ascending dose study. AL001 is a lithium-delivering ionic cocrystal under development as an oral treatment for patients with dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimer’s.
“We are very excited about this important milestone for Alzamend,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We believe these data will confirm AL001’s potential as a replacement of the current lithium-based treatments and may provide a treatment to the over 40 million Americans suffering from Alzheimer’s and other neurodegenerative diseases and psychiatric disorders. We look forward to utilizing these data to move swiftly into a Phase 2 multiple ascending dose study involving Alzheimer’s patients in the first quarter of 2022.”
In late September 2021, Alzamend received positive feedback from the U.S. Food and Drug Administration (“FDA”) regarding the AL002 clinical development plan, including Alzamend’s proposal, to which the FDA agreed, to conduct a combined Phase 1/2 study. 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. The FDA agreeing to the combined Phase 1/2 study has extended the timeline for the submission on the investigational new drug (“IND”) application to be submitted to the FDA.
“We have augmented our clinical trial preparations and executions related to the AL002 combined Phase 1/2 study,” said Stephan Jackman. “The unique nature of our therapeutic is difficult to produce and has required an extended timeline to identify the right manufacturing partner to provide our study drug materials. We also appreciate the FDA’s thorough response, which provided us with significant clarity and advice. We believe it is important to incorporate all of the FDA’s recommendations and guidance, and now anticipate submitting our IND for AL002 in the second quarter of 2022 and commencing a combined Phase 1/2 clinical trial as soon as possible after approval of the IND from the FDA.”
