Early clinical-stage biopharmaceutical company Alzamend Neuro Inc. (ALZN:NASDAQ), which concentrates its efforts on the development of therapeutics to treat neurodegenerative diseases and psychiatric disorders, today announced that "it has received a written response to its meeting request relating to its Type B Pre‑Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) providing a path for Alzamend's planned clinical development of AL002."
"Preclinical work supports AL002 being associated with a positive anti-inflammatory response and a decrease in brain amyloid contents."
The company indicated that "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 Disease (AD)." The firm advised that AL002 works essentially by reducing beta-amyloid plaque.
The company's CEO Stephan Jackman stated, "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…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," CEO Jackman added.
Alzamend Neuro advised that based upon written feedback from the FDA, it expects that it will file its IND by the end of November 2021 and would then target commencement of the AL002 clinical trial in Q1/22.
"Alzamend Neuro started off the day with a market cap of around $198.1 million with approximately 86.9 million shares outstanding."
The company explained further that AL002 is engineered to prevent the formation and break down of beta-amyloids which can form build up in the brain to form plaque. Alzamend noted that this build-up of plaque subsequently blocks neurological brain signals and ultimately leads to symptoms and onset of AD.
According to the company's website, AD affects more than 6.2 million people in the U.S. and is expected to increase to as many as 13 million by 2050. In addition, the disease impacts an even higher number of individuals and family members who serve as caregivers.
Alzamend Neuro is a preclinical stage biopharmaceutical company headquartered in Tampa, Fla. The firm is engaged in creating new medicines and treatments for psychiatric disorders and neurodegenerative diseases. The firm listed that its investigative drug pipeline currently includes AL001, which it described as "a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, proline and salicylate" and AL002 as discussed for AD. The company advised that it licensed each of these product candidates from the University of South Florida Research Foundation Inc.
Alzamend Neuro started off the day with a market cap of around $198.1 million with approximately 86.9 million shares outstanding. ALZN shares opened only slightly higher today at $2.29 (+$0.01, +0.44%) over yesterday's $2.28 closing price. The stock has traded today between $2.2201 to $3.57 per share and closed at $3.08 (+$0.80, +35.09%).
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