Eli Lilly’s anti-amyloid Alzheimer’s drug is designed to be stopped after patients drop below a certain amyloid level in the brain. However, at the Alzheimer’s Association International Conference on Wednesday, Lilly revealed it is studying the potential of maintenance therapy for patients who need it.
Eli Lilly is looking into the possibility of allowing maintenance doses of its Alzheimer’s disease therapy Kisunla for patients who achieve the clearance of amyloid from the brain, potentially helping keep these disease-causing plaques from returning.
Kisunla is designed to be stopped once amyloid plaques have cleared. However, long-term data from the Phase 3 TRAILBLAZER-ALZ 2 study presented at the Alzheimer’s Association International Conference (AAIC) on Wednesday showed that patients reaccumulate amyloid at a rate of 2.4 centiloid per year. This is comparable to the natural accumulation rate, Lilly said.
“Our data suggest that 1,400 mg once a year, if someone needed it, could potentially keep that amyloid down and keep it low and steady,” John Sims, senior medical director at Lilly, told BioSpace prior to the presentation. The pharma is running an addendum study of the TRAILBLAZER-ALZ 6 trial to characterize the ability of such a maintenance dose, given at least a year after original treatment completion, to sustain amyloid clearance.
“One of the questions physicians have is: What do we do with these as they come back?” Sims said, referring to amyloid plaques that return after patients have finished the Kisumla treatment regimen. This follow-up study has just begun enrollment, which Lilly expects to complete early next year, he noted.
Approved in July 2024, Kisunla is an intravenous anti-amyloid antibody that is designed to be terminated once patients’ amyloid levels drop to “minimal levels,” according to the product’s label. This dosing schedule makes Kisunla an attractive option for patients and healthcare providers who don’t want to start life-long treatment.
But a finite treatment course also gives competitors commercial openings to take advantage of. In April, for instance, Biogen and Eisai—which own Leqembi, the first anti-amyloid therapy to win full FDA approval in 2023—said they are ready to absorb patients coming off of Kisunla.
“Patients in general, who are on either of the products, want to stay on product,” Alisha Alaimo, Biogen’s head of North America, said at the time. “There is a fear of coming off and having a decline in their cognition.”
Lilly appears confident that there will be no need for that, however.
The long-term extension data from TRAILBLAZER-ALZ 2—which supported Kisunla’s approval—showed that patients who met the criteria for ending treatment at 52 weeks were able to maintain low levels of amyloid through 154 weeks of follow-up.
The rebound of amyloid in these patients matched the natural rate of amyloid buildup in people with pre-dementia, Sims told BioSpace. “So that’s encouraging, and that suggests a slower process,” as compared with the initial accumulation of amyloid in Alzheimer’s disease, he added.
The long-term readout also “reinforced the importance” of earlier intervention, which resulted in greater amyloid reductions and a more pronounced decrease in the risk of disease progression, according to Lilly’s presentation.
Also at AAIC, the company touted a modified titration regimen for Kisunla that resulted in better safety. Starting patients off with a 350-mg dose that gradually ramps up to 1,400 mg by week 4—as opposed to initiating at 700 mg and jumping straight to 1,400 mg after three weeks, as per the therapy’s original approval—significantly reduced cases of brain swelling.
Lilly had presented early findings from this analysis in October 2024. The FDA approved this adjusted titration schedule for Kisunla in July 2025.
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