CHICAGO, May 3 (Reuters) – An experimental Alzheimer’s drug developed by Eli Lilly and Co (LLY.N) slowed cognitive decline by 35% in a late-stage trial, the company said on Wednesday. , providing what experts say is the strongest evidence yet, clearing sticky amyloid plaques from the brain benefits patients with the deadly disease.
Lilly’s drug, donanemab, met all trial objectives, the company said. It slowed the progression of Alzheimer’s disease by 35% compared to a placebo in 1,182 people with early-stage disease whose brains had deposits of two key Alzheimer’s proteins, beta -amyloid as well as intermediate levels of tau, a protein linked to disease progression and brain cell death. .
The study also evaluated the drug in 552 patients with elevated tau levels and found that when the two groups were combined, donanemab slowed progression by 29% based on a commonly used dementia progression scale. known as the Clinical Dementia Rating Scale (CDR-SB).
Using this scale, experts said Lilly’s findings were roughly equivalent to those of Eisai Co Ltd (4523.T) and Biogen Inc’s lecanemab (BIIB.O), sold under the brand name Leqembi. , which reduced cognitive decline by 27% in patients with early-stage Alzheimer’s disease. in a study published last year.
The results propelled Lilly shares to a record high, up more than 6% to $429.85.
Dr Ronald Petersen, an Alzheimer’s disease researcher at the Mayo Clinic, said Lilly’s trial is the third to show that removing amyloid from the brain slows the progression of the disease, which could dispel some lingering doubts about the benefits of class and amyloid drugs. -lowering theory.
“It’s modest, but I think it’s real,” he said of the benefit, “and I think it’s clinically significant.”
Dr. Erik Musiek, a University of Washington neurologist at Barnes-Jewish Hospital, said the efficacy appears to be as good or better than lecanemab.
“The evidence is really starting to pile up that these drugs work,” he said.
Musiek said the results also offer some of the first evidence of the benefit of earlier treatment. “It really suggests that you need to remove these plaques early, before the tau really starts,” he said.
“RISK WHICH MUST BE CONSIDERED”
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. Cerebral haemorrhages occurred in 31.4% of the donanemab group and 13.6% of the placebo group.
In Leqembi’s Phase 3 trial, the 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%, with two deaths attributed to the disease and a third, after an incident of severe brain swelling.
A research note from SVB Securities analyst David Risinger was titled: “Donanemab succeeds, but safety remains a concern.”
“Obviously we’ve seen benefits here, but there’s some risk that needs to be considered,” said Dr. Eric Reiman, executive director of the Banner Alzheimer’s Institute, which is conducting a study of donanemab in patients. presymptomatic patients.
Lilly said it plans to file for traditional approval in the United States by the end of June, and with regulators in other countries soon after. A company spokesperson said a U.S. approval decision is expected by the end of the year or early 2024.
Alzheimer’s disease experts said they are eager to see the full results of the study, including data on the drug’s performance in people who carry an Alzheimer’s risk gene called APOE4, who were prone to an increased risk of side effects in previous trials.
These results are expected to be presented at a meeting on Alzheimer’s disease in Amsterdam this summer.
Study participants received a monthly intravenous infusion of donanemab. At 12 months, half had no evidence of amyloid plaques, the company said.
It also said that 47% of patients on donanemab in the 18-month trial had no disease progression at 12 months, compared with 29% of the placebo group.
Lilly’s drug is set to become the third in its class on the market following US approval of two similar drugs developed by partners Eisai and Biogen – Leqembi as well as Aduhelm, which have no managed to gain traction with doctors or insurers after showing little evidence that it slowed cognitive decline.
Both have been approved under the FDA’s Accelerated Review Program, based on their ability to clear amyloid plaques.
Leqembi is currently undergoing the standard FDA review process, with a decision expected by July 6.
Lilly is still working on finalizing the price of donanemab and expects it to be in the same range as other similar therapies, CEO David Ricks told CNBC.
More than 6 million Americans live with Alzheimer’s disease, and that number is expected to reach nearly 13 million by 2050, according to the Alzheimer’s Association.
Reporting by Julie Steenhuysen in Chicago and Deena Beasley in Los Angeles; Editing by Bill Berkrot
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