Health

The latest findings for Lilly’s drug suggest the benefits are relatively modest, however, and may be outweighed by safety risks for some patients, said Lon Schneider, a professor of psychiatry at the University of Southern California’s Keck School of Medicine who enrolled patients in the Lilly-funded study. The study found that donanemab increased the risk of serious brain problems.

Researchers designed Lilly’s drug donanemab and Leqembi, from Eisai and Biogen, to work by targeting and reducing amyloid, a substance that forms plaque in the brain and is a prime suspect in fueling the worsening of Alzheimer’s. The approach has been controversial because many of the failed drugs also targeted amyloid, but studies in recent years of Lilly’s and Eisai-Biogen’s drugs have bolstered the evidence.

In the study of more than 1,730 patients, the drug slowed patients’ decline by 35% compared with people who received a placebo over 18 months of treatment, Lilly said. Researchers gave the drug to elderly people who testing indicated were in the early stages of Alzheimer’s. Researchers gauged the drug’s effect by assessing various measures of memory and activities of daily living including driving and managing finances.

Leqembi slowed Alzheimer’s patients’ decline by 27% versus a placebo over 18 months in a separate study, though there were differences in the studies that make direct comparisons difficult. Yet Leqembi’s safety profile might give it an advantage over donanemab with other doctors and patients, analysts said. About 24% of patients taking donanemab had amyloid-related imaging abnormalities that included findings on scans such as brain swelling, while 31% had abnormalities that included bleeding, Lilly said. A majority of cases were mild to moderate, Lilly said. About 1.6% of the abnormalities were classified as serious, including two people who died from them and a third person who died after an abnormality, Lilly said.

The rates of brain abnormalities in the donanemab study were higher than what was seen in the separate study for Eisai’s and Biogen’s Leqembi, analysts said.

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The problem that I have always had with targeting amyloid is that many do have amyloid in their brains but have never shown signs of dementia.