Researchers from Brigham and Women’s Hospital have initiated a clinical trial that will analyze and evaluate an intranasal vaccine to prevent Alzheimer’s disease, according to BioSpace.
The experimental vaccine uses Protollin – the new intranasal immunotherapy made of proteins derived from the outer membrane of certain bacteria.
Protollin works by stimulating the innate immune system — the part of the immune system that serves as the body’s first line of defense — to clear amyloid-beta plaques and tau tangles from the brain, according to Alzheimer’s News Today.
The accumulation of amyloid-beta plaques is one of the hallmarks of Alzheimer’s.
Chinese drug manufacturers I-Mab Biopharma and Jiangsu Nhwa Pharmaceutical (Nhwa) entered an agreement in 2019 for exclusive licenses to develop, manufacture, and commercialize Protollin.
Nhwa will develop and commercialize the vaccine in China, Hong Kong, Macau, and Taiwan, while I-Mab will do so in the rest of the world.
Lead researchers Dr. Howard Weiner said, “Where others have triggered antibody creation by amyloid vaccination or artificially put anti-amyloid antibodies into the patient intravenously, what we’re doing is stimulating the immune system in a natural way not only to clear the beta-amyloid but also to address other abnormalities in the brain.”
In August, I-Mab announced that the Food and Drug Administration (FDA) approved its investigational new drug (IND) application for Protollin.
I-Mab founder, chair and director Dr. JingwuZang said, “Advancing Protollin into clinic is a critical milestone in the search to develop novel therapies for this devastating disease, and we are honored to be engaging in a planning process with partners around the globe and contributing our expertise.”
The FDA approved human trials of Protollin after analyzing its safety and efficacy in animal studies. The investigational vaccine’s immunological approach has presented a significant milestone in the treatment of Alzheimer’s.
In the first human trial, the researchers will enroll 16 participants who are diagnosed with early, symptomatic Alzheimer’s disease. The participants will receive two doses of the experimental vaccine, which will be administered nasally, one week apart.
Dr. Weiner said, “Over the last two decades, we’ve amassed preclinical evidence suggesting the potential of this nasal vaccine for AD.”
“If clinical trials in humans show that the vaccine is safe and effective, this could represent a nontoxic treatment for people with Alzheimer’s, and it could also be given early to help prevent Alzheimer’s in people at risk,” he added.
Over the last 20 years, Dr. Weiner published three papers on the vaccine’s ability to prevent Alzheimer’s.