Historic moment in Alzheimer’s drug development
Words by GOLD newsdesk
Eisai and Biogen have announced positive results from their trial of lecanemab – the first Alzheimer’s drug in a generation to successfully meet primary endpoints in a phase 3 clinical trial.
During the Clarity AD trial, the drug was able to slow the rate of decline in participants’ memory, thinking and function by 27% over an 18-month period, and was also found to help participants with their usual day-to-day activities. The trial included 1,795 people with early-stage Alzheimer’s and mild cognitive impairment due to the disease who received either Lecanemab or a placebo.
“The positive result of the lecanemab, an anti-Aβ protofibril antibody, pivotal study after almost 25 years since Aricept’s launch is an important milestone for Eisai in fulfilling our mission to meet the expectations of the Alzheimer’s disease community,” stated Haruo Naito, Chief Executive Officer, Eisai. “Alzheimer’s disease not only presents a great challenge for patients and their families, but it also negatively impacts society, including decreased productivity, increased social costs and disease-related anxiety. We believe that helping to alleviate these burdens will positively impact society as a whole.”
Dr Susan Kohlhaas, Director of Research, Alzheimer’s Research UK, commented that these results demonstrate a major breakthrough in dementia research. “This is the first drug that’s been shown to not only remove the build-up of a protein called amyloid in the brain, but to have a small but statistically significant impact on cognitive decline in people with early-stage disease,” she explained.
The FDA has additionally agreed that the results of Clarity AD can serve as a confirmation to verify the clinical benefit of lecanemab. Data from Alzheimer’s Disease International shows that the global figure for people with Alzheimer’s could grow to 139 million by 2050 without an effective treatment available, so this landmark breakthrough could spell a positive step toward reducing this figure.