(Bloomberg) -- Eli Lilly & Co. said that a small change in dosing its Alzheimer’s drug Kisunla cut patients’ rate of brain-swelling side effects in preliminary results from a study.
A more gradual increase in the size of the first three infusions of the drug cut the rate of brain swelling over six months of treatment to 14%, Lilly said Tuesday in a statement, compared with 24% among people getting standard doses. Brain swelling can lead to confusion, stroke-like symptoms and, in rare cases, death. Lilly plans to submit the data to drug regulators, seeking a potential label update.
Patients looking for new treatments for incurable Alzheimer’s disease are cautious of swelling and bleeding in the brain linked to both Kisunla and rival medicine Leqembi from Eisai Co. and Biogen Inc. While the side effects don’t always cause symptoms, researchers and doctors are looking for ways to avert them or prevent their most dangerous, life-threatening outcomes.
The difference in brain bleeding, a secondary goal of the trial, wasn’t as dramatic as the impact on swelling. A quarter of those who got the standard dosing regimen showed signs of bleeding, compared with 20% among those getting the new regimen.
The dosing change didn’t eliminate serious side effects. One patient receiving the modified regimen developed brain swelling with seizures and stroke-like symptoms after six doses. The patient died from a brain hemorrhage two days after being treated with a clot-dissolving drug, according to slides presented at the conference.
Before Kisunla was approved, Lilly had begun testing a variety of new strategies — including skipping some doses and administering smaller amounts of the drug more frequently — to see if any helped reduce brain swelling and bleeding. The trial included one group of patients that got the standard dosing regimen, allowing for direct comparisons of side effect rates.
Lilly described the subtle dosing change that had the most favorable impact in a presentation on Tuesday at the Clinical Trials on Alzheimer’s Disease conference in Madrid. In the standard regimen, doctors infuse two vials of the drug monthly for three months, then move up to the full four-vial dose in the fourth month. In Lilly’s experimental approach, patients got one vial the first month, two in the second month and three in the third before moving to the four-vial dose.
Kisunla and Leqembi are the first drugs approved to slow the progression of Alzheimer’s. Both remove a toxic protein called amyloid from patients’ brains. The drugs slow cognitive decline modestly, and multiple brain scans are needed to detect swelling and bleeding early.
The trial is ongoing, and results for a year of treatment with the modified regimen should be available early next year, Lilly said in a statement.
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