New hopes for the one million Alzheimer’s patients in Italy and the 47 million worldwide. An experimental new drug has been shown to significantly slow the progression of the disease. Approximately 35% the cognitive decline related to the same and 40% the ability to carry out daily activities. The results of an experimental study were announced by the pharmaceutical company Eli Lilly, which has been engaged in research against this disease for years and is ready to soon request authorization for marketing.
In a “double-blind” controlled study, i.e. with volunteers treated partly with the monoclonal drug and partly with a simple placebo, on almost 1,182 people with early forms of Alzheimer’s, donanemab, this is the name of the product, slowed down the progression of symptoms by 35% over an 18-month period. This effect was measured by comparing ability to perform daily activities such as handling money, driving, engaging in hobbies, and having conversations about current events. Side effects included micro-hemorrhaging.
In Alzheimer’s disease, two key proteins, tau and amyloid beta, build up in tangles and plaques, collectively known as clumps, which cause brain cells to die. donanemab targets amyloid-beta, as does lecanemab, another drug developed by Biogen and Eisai, which showed a decline of 27% and was approved by the United States last January.
Lilly said it will quickly submit the results of the new study to the U.S. Food and Drug Administration and other global regulators.
“We are pleased that donanemab has delivered positive clinical results with compelling statistical significance,” Lilly chief scientist and chief physician Daniel Skovronsky said in a statement. “This is the first Phase 3 study of any investigational Alzheimer’s drug to provide a 35% slowing of clinical and functional decline,” he adds. These results, for Mark Mintun, vice president of the Eli Lilly research group, “suggest that people in the early stage of the disease may be the most responsive to amyloid-targeted therapies.”
Donanemab would be added to another drug with the same mechanism of action, lecanemab, approved urgently by the FDA. Although also designed to eliminate the “sticky” substance of the brain called “beta amyloid” which causes brain plaques which causes Alzheimer’s, the drug already approved in the US would however have lower benefits than those now announced by Eli Lilly for its monoclonal. Even if the announcements will now have to be followed by the publication of data on which the scientific community will be called to have its say. Also because these are high-cost drugs for public health services running out of oxygen, not only in Italy.