Protollin: I-Mab Biopharma’s Protollin: Effectiveness & Status of Clinical Trials

Last Updated: April 26, 2022


What is I-Mab Biopharma Protollin Drug?

Protollin is a new drug that is still in clinical trials which was developed by I-Mab Biopharma with the goal of decelerating the damage caused by Alzheimer’s disease in the brain. Protollin is a nasal vaccine (spray) that targets the immune system to prevent and treat Alzheimer’s disease. How is this drug different from other drugs on the market? At this time, due to its unique nature targeting the immune system via natural response, there are no comparisons for this new Alzheimer’s drug. By increasing the body’s natural resistance and immunity to foreign substances, it slows progression and aids in prevention of the disease. Protollin is made up of bacteria’s outer membrane and lipopolysaccharides that have the ability to regulate immune cells. Protollin is a biologic.


What is a Biologic?

Biologics are naturally derived and made to focus on helping and improving a specific part of your immune system that is compromised. Containing DNA, and therefore proteins and peptides, they are sourced from living organisms and / or their extracts.


How Does Protollin work?

As the therapy (nasal spray) is administered and reaches the brain, a subsequent response to the immune system is given. The goal of the immune’s response is to prevent the accumulation of beta-amyloid protein plaques and its tau protein tangles. Both the plaques and tangles are benchmarks for Alzheimer’s disease. Protollin stimulates the formation of white blood cells found in the lymph nodes in the head and neck to amass a brain reaction that clears up the malicious beta-amyloid plaque.


Benefits and Side Effects of Protollin

While Alzheimer’s disease is incurable at this time, brain function and improved memory are being shown in patients who take the drug. Protollin´s benefits are:

-Prevention of the build up of beta-amyloid plaque
-Strengthening immune cells located in the brain

For more information on projected benefits check out the clinical trials in the section below.

At this time, there are no reported side effects because the only published study was on mice in 2012. Researchers are hoping it is safe for people because of its biological origin that regulates the immune system.


Status of Protollin Clinical Trials

FDA approval was granted in July 2021 by Brigham and Women’s Hospital in Boston, Massachusetts. Currently in Phase 1, sixteen participants were administered two doses of the vaccine (nasal spray) one week apart. Clinicians at the Ann Romney Center for Neurological Diseases measured change in patients’ immune systems through their white blood cells. Scientists are looking at the change in cell surface markers, information from particular genes and their specific proteins, and how affected cells behave.

All participants ranged in age from 60 to 85 years old, were in good overall health, and were representative of early Alzheimer’s through PET scans that showed an excess of beta-amyloid plaque. More information on the trial, its participation and enrollment, (that is open until the end of May 2022) can be seen here.

Protollin is in a very small test group in Phase1 of its clinical trials. At this point, the goal is to see its level of protection and functionality in the body. Scientists are trying to prove it would be a safe, non toxic therapy for Alzheimer’s disease.


Availability, Cost & Insurance Coverage of Protollin

Given that Protollin is in Phase 1 of the 3 clinical trials that it must pass to get FDA approval, it will be years before it would be available to the general public even if it is proven to be a safe and effective treatment for Alzheimer’s disease.

What will this new treatment cost? The cost of Protollin is unknown because the drug is too new and still in the beginning stages of its clinical trials.

The same is said for the question as to if insurance companies would cover this new treatment. Whether Protollin would be covered by Medicare, Medicaid and/or private insurance is unknown; there will not be concrete information until it receives its final FDA approval.