Experimental drug slows disease progression by 27%.

The Japanese pharmaceutical company Eisai has announced that the final phase of the study I was conducting with a experimental drug, lecanemabfor the treatment of Alzheimer’s disease has shown positive results in the treatment of slowing the worsening of the disease: lecanemab appears to reduce worsening by up to 27%. of Alzheimer’s symptoms. Eisai has published this Wednesday the results of the. clinical trial, the third and final phase of its analysis on this new treatment for the neurodegenerative disease that it has been investigating together with U.S. pharmaceutical company Biogen.

All the details of the final result will be presented in November, at a congress in San Francisco (USA). If these “hopeful” data are finally confirmed, it would be the “first drug that modifies the natural course of Alzheimer’s disease”, values the director of the Pasqual Maragall Foundation, Arcadi Navarro.

The clinical trial 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.

Patients were divided into two groups: members of one were given the drug once every two weeks for 18 months, while the other was given a placebo, in order to investigate changes in their cognitive functions.

After a year and a half, the group treated with lecanemab presented a 27% reduction in symptom worsening. compared to the one who received 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.

“Cautious optimism.”

“We have known for some time that this drug is being investigated. Today the Japanese company came out with this press release, they are. promising hints that we must take with caution until we have the details, in the November congress”, insists Navarro. The director of the Fundació Pasqual Maragall values the data as “very encouraging”.

“The companies say they have demonstrated a slowing of cognitive decline. If confirmed, it would be the first time that there is a drug that modifies the natural course of the disease. But we have to wait until November. We can’t judge the movie by the title.” he insists.

“We take the information with cautious optimism,” Navarro points out. At the moment there are no drugs that cure or slow down Alzheimer’s disease. But research is underway about 130 and lecanemab, if approved, would be the first to be released.

Navarro opts for prudence because he remembers what happened last year with another drug, lecanemab. aducanumab, which was the first Alzheimer’s drug approved in the U.S. in 18 years. “There was a big controversy: the FDA approved it against the vote of the experts because it its efficacy was weak and it had notable side effects.” Navarro recalls. The European Medicines Agency (EMA) rejected its approval in Europe and multinationals such as Biogen withdrew their application for authorization.

Halt to its progression

Lecanemab is designed to prevent the progression of Alzheimer’s disease. by binding an antibody to beta-amyloid (which occurs in abnormal accumulations in the brains of patients with this disease, the most common form of dementia) and eliminating it, to prevent the destruction of nerve cells.

If ultimately positive, the drug would still have to be approved by the U.S. drug agency, the FDA. Eisai plans to discuss its findings with regulatory authorities in order to apply by March 2023 for approval of the drug in the US, Japan and Europe.