EXCLUSIVE: Alzamend Neuro Starts Phase 1/2A Trial For Its Alzheimer's Immunotherapy Vaccine

Alzamend Neuro Inc ALZN has initiated a Phase 1/2A trial for its immunotherapy vaccine (ALZN002) to treat mild to moderate dementia of Alzheimer’s type.

What Happened: The trial will assess the safety, tolerability, and efficacy of multiple ascending doses of ALZN002 compared with a placebo in 20-30 subjects with mild to moderate morbidity. 

The primary goal of this trial is to determine an appropriate dose of ALZN002 for a larger Phase 2B efficacy and safety trial, which Alzamend expects to initiate within three months of receiving data from the initial trial. 

Why It Matters: “Intermittent use of our immunotherapeutic vaccine (ALZN002) may be expected to limit the number of infusions needed, may reduce the potential for adverse reactions, and provide more substantive cognitive and functional outcomes to the millions of Americans afflicted with this devastating disease,” said Stephan Jackman, CEO of Alzamend. 

ALZN002 is a proprietary “active” immunotherapy product, which means each patient’s immune system produces it.

It consists of autologous dendritic cells (DCs), activated white blood cells taken from each patient that are engineered outside the body to attack Alzheimer’s-related amyloid-beta proteins. 

These DCs are pulsed with a novel amyloid-beta peptide designed to bolster the ability of the patient’s immune system to combat Alzheimer’s. 

Most recently, Alzamend Neuro completed the clinical portion of its Phase 2A multiple ascending dose (MAD) study of AL001 in subjects with dementia related to Alzheimer’s. 

Price Action: ALZN shares closed at $0.43 on Friday.