Start of the first clinical trial of a nasal vaccine against Alzheimer’s disease

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It is the culmination of almost 20 years of research. Brigham and Women’s Hospital in Boston just announced that it is beginning a clinical trial to test the safety and efficacy of a new nasal vaccine. This vaccine, formulated from a substance that stimulates immunity (Protollin), aims to prevent and slow the progression of Alzheimer’s disease, a form of dementia that affects more than 50 million people in the world.

Alzheimer’s disease is the most common cause of dementia. It is the result of an accumulation of amyloid deposits and the progressive degeneration of neurons; It is characterized by impaired memory and executive functions, impaired reasoning skills, and disorientation. To date, there is no treatment, but research in this area, which has been particularly prolific in recent years, has provided a better understanding of the disease, in particular its risk factors and the physiological mechanisms involved.

This phase 1 trial will involve 16 participants, ages 60 to 85, all with early-stage Alzheimer’s disease, but generally in good health. They will receive two doses of the vaccine a week apart, the hospital said. Like any phase 1 trial, the goal here is to determine the safety and tolerability of the nasal vaccine. The researchers will also evaluate the effects of Protollin on the immune response of the participants.

An adjuvant that stimulates the immune system.

The vaccine uses the immune modulator Protollin, an experimental intranasal agent that stimulates the immune system, which can help fight certain diseases. A study published in 2004 showed that this adjuvant, combined with influenza antigens, increased serum immunoglobulin levels up to 250 times compared to immunization with antigens alone. Composed of proteins derived from bacteria, it has already been used safely in humans as an adjuvant to other vaccines.

Scientists hope that it can similarly activate the body’s immune system to attack beta-amyloid protein plaques, one of the hallmarks of Alzheimer’s disease. “The immune system plays a very important role in all neurological diseases,” said Howard Weiner, who led the research. If this trial is successful, the researchers believe this new approach could help treat other neurodegenerative diseases.

Protollin is developed, manufactured and marketed by I-Mab Biopharma and Jiangsu Nhwa Pharmaceutical, two Chinese pharmaceutical companies (which are also funding this trial). The product has been designed to activate the white blood cells found in the lymph nodes on the sides and back of the neck (hence the nasal spray method of administration) to migrate to the brain and remove beta-amyloid plaques. . “Over the past 20 years, there has been growing evidence that the immune system plays a key role in the removal of beta-amyloid. This vaccine harnesses a new arm of the immune system to treat Alzheimer’s disease, ”said Tanuja Chitnis, professor of neurology at Brigham and Women’s Hospital and principal investigator on the trial.

This first landmark human trial will provide an opportunity for the research team to measure the effect of nasal protolin on the immune response, in particular its effects on white blood cells, by examining cell surface markers, genetic profiles and functional tests. . “If human clinical trials show that the vaccine is safe and effective, it could represent a non-toxic treatment for people with Alzheimer’s disease, and it could also be given early to help prevent Alzheimer’s disease in people at risk,” he says Howard Weiner.

Various treatments in development

According to the National Institute on Aging, Alzheimer’s disease is the sixth leading cause of death in the United States. In France, almost a million people are affected by the disease and it is estimated that 225,000 new cases are diagnosed each year. Researchers around the world have been working for years developing new drugs to treat or delay Alzheimer’s disease. Often times, experimental drugs can eliminate amyloid plaques, but they do not resolve the symptoms of patients with many disabilities on a daily basis, namely loss of autonomy and reduced cognitive abilities.

Recently, researchers have developed a treatment and a vaccine for the disease. Tested only on mice, their products look very promising. Their approach differs from other experimental treatments in that they target a very specific form of the beta-amyloid protein. If your results are very encouraging, it will probably take years of research before receiving a treatment for humans.

In June, the Food and Drug Administration approved the first new drug against Alzheimer’s disease in 20 years: it is Aduhelm (or aducanumab), developed by the American laboratory Biogen in collaboration with the Japanese company Eisai Co .; It was designed to destroy amyloid plaques that build up in the brain. That is, in 2019, Biogen announced the end of its two phase 3 clinical trials, after negative results. Then, six months later, the lab announced that their treatment was finally effective for a subset of participants.

Therefore, the FDA’s decision generated controversy, especially after warnings from independent advisers that the drug had not been shown to actually help delay the disease. It would also carry the risk of serious side effects. The European Medicines Agency has so far opposed the treatment; he is expected to make his final decision in mid-December. According to CBS News, the FDA has asked Biogen to conduct a follow-up study to confirm the drug’s benefits; If this study is not conclusive, the US authority could withdraw it from the market.

Brigham and Women’s Hospital

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