The North American FDA (Food and Drug Administration) has just granted the status of ‘innovative therapy’ to gantenerumab, a drug designed to slow or even prevent the cognitive decline and memory loss typical of Alzheimer’s disease. With this distinction, it is expected to speed up the timelines so that it can be made available to the public, by allowing, among other things, the priority review and supervision of clinical trials by the body.
In fact, the drug is already in phase three clinical trials , the last necessary for it to begin to be used.
What is gantenerumab?
Gantenerumab, which is being developed by the pharmaceutical company Roche, is an anti-beta amyloid antibody igG1 (immunoglobulin G1), which means that it binds to aggregated forms of beta-amyloid (a protein with important functions in the activation of kinases, protection against oxidative stress, cholesterol transport and antimicrobial activity), the main component of the so-called ‘senile plaques’ found in the brain of people with Alzheimer’s.
Thanks to this, it seems to reduce the formation of these plaques (the antibodies signal the immune system the targets to fight), which in turn seems to be related to a less drastic expression and a slower progression of the disease.
In fact, the trials carried out so far with gantenerumab have shown that it effectively reduces amyloid plaque in the brain of patients with sporadic Alzheimer’s disease (that is, it does not have a clearly identifiable genetic origin) and autosomal Alzheimer’s disease. dominant (which is clearly hereditary).
The trials that gantenerumab is currently undergoing soon, named GRADUATE 1 and 2, will observe the effects on amyloid plaque and other biomarkers, the safety and the efficacy of the drug in more than 2,000 patients with early Alzheimer’s disease. .
These patients are being treated for more than two years in 350 centers in more than 30 countries with monthly doses of 1,020mg, and there is a control group treated with placebo.
If once these studies are completed (in the second half of 2022) the results are satisfactory , gantenerumab could already be used in the clinical setting.