ELI LILLY DRUG SHOWS PROMISE IN TREATING ALZHEIMER’S

The race to bring Alzheimer’s drugs to patients heated up Monday when Eli Lilly released promising new clinical findings for a treatment that will compete head to head with one developed by Cambridge-based Biogen and its Japanese business partner that won full US approval this month. Lilly, the pharma giant based in Indianapolis, said its experimental drug, called donanemab, slowed cognitive and functional decline by 35 percent in a late-stage clinical trial of Alzheimer’s patients with beta amyloid deposits in their brains, one common marker of the memory-robbing disorder. The drug extended the time before early-stage patients progress to the next stage of the disease by four and a half to seven and a half months, the study found. Fortyseven percent of a segment of earlystage trial participants showed no disease progression after one year on donanemab. The results were released Monday morning at the 2023 Alzheimer’s Association International Convention in Amsterdam and simultaneously published in the Journal of the American Medical Association. Lilly’s data, which relied on multiple scales of cognition and brain function for subgroups of those participating, showed one of the largest gaps seen in any trial in disease progression between the earliest-stage patients taking Lilly’s drug and those taking a placebo, said Mark A. Mintun, the Lilly group vice president for neuroscience research and development. Tellingly, those earlieststage patients taking Lilly’s drug showed a 60 percent slowing of cognitive decline compared to those taking a placebo. Some of the Alzheimer’s patients whose amyloid deposits had been completely removed were even switched to a placebo during the trial, Mintun said. The latest results also marked the first time any company had replicated positive data seen in an earlier Alzheimer’s trial, he said. Lilly has applied for Food and Drug Administration approval of donanemab, and the agency is expected to rule on the drug by year-end. FDA officials granted full approval to Leqembi, the drug being marketed by Biogen and Eisai of Japan, on July 6. It was priced at $26,500 annually per patient. Executives at Lilly have not yet said what they plan to charge for donanemab. — ROBERT WEISMAN