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Alzheimer’s, eyes on a new monoclonal antibody

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A NEW experimental drug for the treatment of Alzheimer’s disease has just received the designation of “Breakthrough Therapy” by the Food and Drug Administration (Fda), the procedure by which the US regulatory agency indicates the most promising therapies, the development of which should therefore be accelerated. It is gantenerumab, a monoclonal antibody that can be administered by injection under the skin, directed against the plaques of beta-amyloid, the toxic protein that accumulates in the brain, a hallmark of Alzheimer’s and considered the cause of the disease.

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Studies in progress

According to reports from the company that developed the drug, Roche, the FDA’s decision is based on several clinical studies (notably the extensions of the SCarlet RoAD and Marguerite RoAD studies) in which gantenerumab has been shown to significantly reduce plaque of beta-amyloid in both sporadic and hereditary forms. Based on this information, two other clinical trials – GRADUATE 1 and 2 – have been designed and are currently underway in over 350 centers in more than 30 countries: they will evaluate the efficacy and safety of gantenerumab in approximately two thousand patients and the results are expected for the second half of 2022. The aim of these studies is to understand the effect of the new antibody on the amyloid load and on the biomarkers of disease progression, both in the advanced and early phase (from prodromal to mild).

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Alzheimer’s immunotherapy

The news comes a few months after the US agency’s (discussed) approval of the first monoclonal antibody, aducanumab, for patients with early Alzheimer’s. Even in that case, the antibody binds to the aggregates of the beta-amyloid protein and, thanks to an inflammatory process, “dissolves” them.

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This immunotherapy strategy based on monoclonal antibodies is one of the many ways that have been tested for some time against this disease, which affects about 600,000 people in Italy alone: ​​an increasing number, given the progressive aging of the population. Other strategies involve hyperphosphorylation of the tau protein, which also forms clusters responsible for neurodegeneration, or the reduction of inflammation and oxidative stress.

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