US biotech Alzamend Neuro has started a first of its kind phase 1/2a trial of an immunotherapy vaccine aimed at helping patients suffering with mild-to-moderate Alzheimer’s dementia fight the disease.
The first-in-human, double-blind, placebo-controlled, randomised parallel group trial will enlist 20-30 participants to evaluate the safety, tolerability, and efficacy of the vaccine, known as ALZN002, in multiple ascending doses compared to an inactive drug.
Alzamend Neuro said the purpose of the study is to determine the appropriate dose of ALZN002 for the treatment of patients with Alzheimer’s before moving to a larger efficacy and safety clinical trial, expected to begin within three months of receiving data from the initial evaluation.
ALZN002 is produced from a patient’s own immune system. It is a way of using activated white blood cells engineered outside the body to attack Alzheimer’s-related amyloid-beta proteins, helping them fight the disease.
Milton Ault III, founder/chairman Emeritus of Alzamend, said: “We founded Alzamend with a mission to combat the devastating impact of Alzheimer’s disease, which has affected members of my own family.
“Our goal has always been to bring two groundbreaking treatments licensed from the University of South Florida into clinical trials and provide hope to the millions suffering from this affliction.
“Today, I am thrilled to announce that we have taken a significant step forward in achieving these objectives.”
Alzamend Neuro, an early clinical stage biopharmaceutical company, believes that strategies to strengthen the immune system in the elderly, who are most susceptible to the development of Alzheimer’s, could greatly enhance the effectiveness of immune-based approaches towards the progressive disease.
This therapy is intended to work by stimulating the body’s own immune system to stop the formation and breakdown of beta amyloids, which build up in the brain and block the neurological brain signals, eventually leading to the symptoms and onset of Alzheimer’s.
Beta amyloid protein has been directly linked to Alzheimer’s. Increased levels of extracellular plaques in the brain composed of amyloid beta peptide 1-42 are seen in Alzheimer’s patients when compared to healthy people.
Attempts have been made to help reduce the amount of amyloid beta peptide 1-42 through vaccines that generate an immune response to the protein.
The challenge has been that though effective in reducing the level of the protein, the inflammatory response has been such that the intended benefits are not seen.
These vaccines have used a substance to enhance the body’s own defence mechanism to generate the necessary immune response, But it is believed adjuvants trigger the unwanted surplus inflammation.
Alzamend has licensed rights to a vaccine using autologous cells that does not need an adjuvant and, the company believes, will trigger the immune response, which should help eliminate the amyloid beta peptide 1-42 without generating the excess inflammation and therefore, have a positive clinical effect.
The company also believes that the vaccine helps the impaired immune system that is thought to be the major issue in Alzheimer’s patients.