© Reuters. FILE PHOTO: Dr. Seth Gill points to evidence of Alzheimer’s disease in positron emission tomography scans at the Center for Alzheimer’s Disease Research and Treatment (CART) at Brigham and Women’s Hospital in Boston, Massachusetts, US, March 30, 2023.
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Written by Julie Stenhuysen and Dina Beasley
CHICAGO (Reuters) – An experimental Alzheimer’s drug developed by Eli Lilly and Co. (NYSE: NYSE) slowed cognitive decline by 35% in closely monitored late-stage trials, the company said on Wednesday, raising hopes for an effective treatment. second for the brain. Wasting disease.
Donanimab met all of the trial’s objectives. Lilly said it slowed the progression of Alzheimer’s disease by 35% to 36% compared to a placebo in 1,182 people diagnosed with early-stage disease based on scans showing brain deposits of amyloid and intermediate levels of tau.
Another 552 patients in the trial had high levels of tau, indicating that they would be less likely to respond to treatment.
After combining the two groups, dunanimab was shown to slow the progression of Alzheimer’s disease by 22% using a measure developed by Lilly to measure cognition and activities of daily living, and by 29% based on a more common measure of dementia progression.
“This is the strongest Phase 3 data for the treatment of Alzheimer’s disease to date,” said Maria Carrillo, chief scientific officer of the Alzheimer’s Society.
Using a commonly used dementia measure, results from trials published last year showed that Eisai Co (OTC:) Ltd and Biogen Inc’s Leqembi (NASDAQ::) reduced the rate of cognitive decline by 27% in patients with early-onset Alzheimer’s disease.
Wednesday’s data sent Eli Lilly shares up 5.6% to $427.05, while rival Biogen fell 2.5% to $301.50 in premarket trading.
In the donanemab treatment group, Lilly said brain swelling, a known side effect of drugs of this type, occurred in 24% of the participants, with 6.1% experiencing symptoms. Cerebral hemorrhage occurred in 31.4% of the donanimab group and 13.6% of the placebo group.
In the Leqembi Phase 3 trial, the drug was associated with brain swelling in approximately 13% of study participants.
The incidence of serious brain swelling in the dunanimab study was 1.6%, Lilly said, including two deaths attributed to the condition, and a third following an incident of serious brain swelling.
“Dunanimab is the new gold standard for efficacy in Alzheimer’s disease,” Citi analyst Andrew Baum said in a research note. “Need to educate neurologists to reduce safety risks.”
Dr. Eric Riemann, executive director of the Alzheimer’s Institute (NASDAQ:), which is running an Alzheimer’s prevention study of donanimab in asymptomatic patients, said he was “very excited” about the results. “Obviously one saw the benefits here, but there are some risks that need to be taken into account.”
Lilly said it plans to file for traditional US approval by the end of June, and with regulators from other countries shortly thereafter.
“There are risks in medicine, but I think when you look at these findings in the context of a potentially fatal, life-threatening disease, they are very meaningful,” Ann White, executive director of neuroscience at Lilly, told Reuters in an interview.
Study participants received a monthly intravenous infusion of donanimab. When subsequent brain scans showed that the amyloid had been removed, treatment was stopped and the volunteers were transferred to the dummy arm of the study. The company said half of the trial participants had no evidence of amyloid plaques at 12 months.
She also said that 47% of patients with donanimab in the 18-month trial had no disease progression at 12 months, compared with 29% in the placebo group.
Lilly’s drug is likely to become third in its class on the market after the US approval of two similar drugs developed by partners Eisai and Biogen – Leqembi and Aduhelm, which failed to gain traction with doctors or insurance companies after showing little evidence that they slowed cognitive decline. . .
Both are approved under the US Food and Drug Administration’s accelerated review program, based on their ability to remove amyloid plaques.
Leqembi is currently going through the FDA’s standard review process, with a decision due by July 6.
More than 6 million Americans are living with Alzheimer’s disease, and the number is expected to rise to nearly 13 million by 2050, according to the Alzheimer’s Association.