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An experimental Alzheimer's drug developed by Eli Lilly and Co slowed cognitive decline by 35% in a late-stage trial, the company said on Wednesday, providing what experts say is the strongest evidence yet that removing sticky amyloid plaques from the brain benefits patients with the fatal disease. Lilly's drug, donanemab, met all goals of the trial, the company said. It slowed progression of Alzheimer's 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 with disease progression and brain cell death. The study also evaluated the drug in 552 patients with high levels of tau and found that when both groups were combined, donanemab slowed progression by 29% based on a commonly used scale of dementia progression known as the Clinical Dementia Rating Scale (CDR-SB). Using that scale, experts said Lilly's findings were roughly on par with Eisai Co Ltd and Biogen Inc's lecanemab, sold under the brand name Leqembi, which reduced cognitive decline by 27% in patients with early Alzheimer's in a study published last year. The results drove Lilly's shares to a record high, up more than 6% at $429.85. Dr. Ronald Petersen, an Alzheimer's researcher at Mayo Clinic, said Lilly's trial is the third to show removing amyloid from the brain slows progression of the disease, which could put to rest some lingering doubts about the benefits of drugs in the class and the amyloid-lowering theory. "It's modest, but I think it's real," he said of the benefit, "and I think it's clinically meaningful." Dr. Erik Musiek, a Washington University neurologist at Barnes-Jewish Hospital, said the efficacy looks as good or better than lecanemab.

Diabetes drugs that also promote weight loss such as Novo Nordisk's Ozempic, becoming a darling of celebrities and investors, are being studied to tackle some of the most difficult-to-treat brain disorders, including Alzheimer's disease. Diabetes regimens, from Ozempic to old mainstays like insulin and metformin, appear to address several different aspects of the metabolic system implicated in Alzheimer's disease, including a protein called amyloid and inflammation, researchers say. The hope is that improving glucose utilisation and tamping down inflammation in the entire body - including the brain - could slow progression of debilitating diseases like Alzheimer's and Parkinson's. Several scientists interviewed by Reuters news agency pointed to mounting research supporting testing diabetes drugs against neurodegenerative diseases. Results are years away and success uncertain. But interest has been buoyed by recent positive data on Alzheimer's drugs developed by Eisai with partner Biogen and by Eli Lilly demonstrating that removing sticky amyloid plaques accumulated in the brain can slow cognition decline caused by the fatal mind-wasting disease. Those successes followed decades of futility that had left many questioning the validity of the amyloid theory behind most experimental Alzheimer's drugs.

The MHRA on Wednesday granted a license for Eli Lilly's new Alzheimer's treatment, donanemab, for use in adults with mild cognitive impairment or mild dementia due to Alzheimer's disease. However, the drug will not be available on the NHS, as the National Institute for Health and Care Excellence (NICE) concluded that it "does not currently demonstrate value for the NHS." The health spending watchdog explained that the costs of providing donanemab, including regular infusions and intensive monitoring for serious side effects, outweigh the relatively small benefits it offers to patients, and so it "cannot currently be considered good value for the taxpayer." Helen Knight, director of medicines evaluation at NICE, said: "For NICE to be able to approve a medicine for use in the NHS it must provide additional benefits to patients, and it must also represent a good use of NHS resources and taxpayers' money. Donanemab (also called Kisunla) is a monoclonal antibody drug given by infusion (through a drip in the arm). It targets and reduces beta-amyloid proteins, whose abnormal buildup is associated with Alzheimer's disease. Clinical trial evidence suggests that the monthly injection can slow Alzheimer's disease progression by 4 to 7 months.