If the data is confirmed, “it would be the first treatment that modifies the natural course of the disease”, specifies the Pasqual Maragall Foundation.
The Japanese pharmaceutical company Eisai has announced that the final phase of the study I was leading with a experimental drug, lecanemabfor the treatment of Alzheimer’s disease has shown positive results in the treatment of slow down the worsening of the disease: lecanemab seems reduce aggravation by up to 27%. Alzheimer’s symptoms. Eisai published this Wednesday the results of the. clinical test, the third and final phase of its analysis on this new treatment for the neurodegenerative disease that he is studying in collaboration with an American pharmaceutical company Biogenic.
All the details of the final result will be presented in November, at a congress in San Francisco (USA). If these “hopeful” data were finally confirmed, it would be the “first drug that modifies the natural evolution of Alzheimer’s disease”, appreciates the director of the Pasqual Maragall Foundation, Arcadi Navarro.
The clinical test began in March 2019 and involved 1,795 people from Japan, the United States and Europe with mild cognitive impairment (dementia) or early-stage Alzheimer’s with abnormalities of beta-amyloid (a key peptide in its development) confirmed.
Changes in cognitive functions.
The patients were divided into two groups: members of one received the drug once every two weeks for 18 months, while the other received a placebo, to study changes in their cognitive functions.
After a year and a half, the group dealt with lecanemab presented a 27% reduction in symptom aggravation. compared to the one who received the placebo, and already after six months “the treatment showed statistically significant changes” in cognitive evolution, according to the results of the study.
Another trial involving 111 patients in China is currently underway.
“We have known for some time that this drug is under investigation. Today the Japanese company released this press release, they are. promising clues which we have to take with caution until we have the details, at the November congress,” insists Navarro. The director of the Fundació Pasqual Maragall considers the data as “very encouraging”.
“Companies say they have demonstrated a slowing cognitive decline. If confirmed, it would be the first time there has been a drug that alters the natural course of the disease. But we have to wait until November. We can’t judge the film by the title. He insists.
“We take the news with cautious optimism,” Navarro said. Currently, there is no drug that cures or slows down Alzheimer’s disease. But research is ongoing about 130 and lecanemab, if approved, would be the first to be released.
Navarro opts for caution because he remembers what happened last year with another drug, lecanemab. aducanumab, which was the first Alzheimer’s drug approved in the United States in 18 years. “There was a big controversy: the FDA approved it against the experts’ vote because it its effectiveness was low and it had noticeable side effects. recalls Navarro. The European Medicines Agency (EMA) has rejected its approval in Europe and multinationals such as Biogen withdrew their request for authorization.
Stopping its progress
Lecanemab is designed to prevent the progression of Alzheimer’s disease. by binding an antibody to beta-amyloid (which occurs in abnormal buildups in the brains of patients with this disease, the most common form of dementia) and removing it, to prevent nerve cell destruction.
If ultimately positive, the drug will still need to be approved by the US drug agency, the FDA. Eisai plans to discuss its findings with regulatory authorities in order to seek approval of the drug in the United States, Japan and Europe by March 2023.