by An experimental Alzheimer’s disease drug developed by drugmaker Eli Lilly and Co has successfully slowed patients’ brain cognitive decline by 35% in a carefully monitored late-stage trial, the company has said. today, raising hopes for a second effective treatment for brain-destroying disease.
The drug, called donanemab, met all of the trial’s objectives. It slowed the progression of Alzheimer’s disease by 35-36% compared to a placebo given to 1,182 people diagnosed with early-stage disease based on tests showing amyloid protein deposits and intermediate levels of T protein in the brain, Lilly noted.
The other 552 patients in the trial showed elevated levels of T in the brain, suggesting they are less likely to respond to treatment.
After combining the two groups, donanemab was shown to slow the progression of Alzheimer’s disease by 22%, based on a scale developed by Lilly to measure human cognition and activities of daily living, and 29% based on a more commonly used scale for progression of dementia. .
“This is the strongest phase 3 data for an Alzheimer’s treatment to date,” said Maria Carrillo, chief scientist of the Alzheimer’s Association of America.
Using the classic dementia scale, trial results published last year showed that two other partner companies, Eisai Co Ltd and Biogen Inc Leqembi, were able to reduce the rate of cognitive decline by 27% in patients with early-stage Alzheimer’s disease.
Today’s data sent shares of Eli Lilly up 5.6% to $427.05, while rival Biogen fell 2.5% to $301.50 in early trading.
In the donanemab treatment group, Lilly said brain swelling, a known side effect of drugs of this type, occurred in 24% of participants, of whom 6.1% experienced symptoms. Brain bleeds occurred in 31.4% of the donanemab group and 13.6% of the placebo group.
On the other hand, in Leqembi’s phase three trial, his drug was associated with brain swelling in nearly 13% of study participants.
Lilly said the incidence of severe brain swelling in the donanemab study was 1.6%, including two deaths from the disease, and a third patient experienced fatal severe brain swelling.
The benefits and the risks
Dr. Eric Reinman, executive director of the Banner Alzheimer Institute, which is conducting an Alzheimer’s disease prevention study of donanemab in presymptomatic patients, said he was “very excited” about the results. “Obviously we saw benefits here, but there is some risk that needs to be considered,” he explained.
Lilly said it plans to seek FDA approval for its drug by the end of June and will do the same with regulators in other countries in a second year.
“There are risks in medicine, but I think when you look at these results in the context of a life-threatening and life-threatening disease, (they) make a lot of sense,” Anne White, director of Lilly Neuroscience, told Reuters in an interview.
Study participants received a monthly intravenous dose of donanemab. When brain scans showed that the amyloid had been removed, treatment was stopped and the volunteers switched to the placebo arm. Half of the trial participants showed no samples of amyloid plaques after 12 months, the company said.
She also said that 47% of patients who received donanemab in the 18-month trial had no disease progression within 12 months, compared with 29% in the placebo group.
Lilly’s drug is likely to become the third in its class on the market after the FDA approved two similar drugs developed by Eisai and Biogen – Leqembi and Aduhelm – which failed to win the interest of doctors and nurses. insurers after failing to show enough evidence that they slowed cognitive decline from the disease.
Both have been approved under the FDA’s Accelerated Review Program due to their ability to remove amyloid plaques.
Leqembi’s drug is currently undergoing the FDA’s standard review process, with a decision expected by July 6.
Lilly is still working to finalize the price of donanemab and plans to price it in the same range as other similar treatments, company CEO David Ricks told CNBC.
More than 6 million Americans live with Alzheimer’s disease, and that number is expected to reach 13 million by 2050, according to the Alzheimer’s Association of America.
