Eli Lilly is considering the use of maintenance doses of its Alzheimer’s disease therapy Kisunla for patients who have achieved clearance of amyloid from the brain, as announced on July 15. The company aims to determine whether ongoing low-dose treatment could help prevent the return of disease-causing plaques.
Kisunla is currently designed to be discontinued once amyloid plaques are cleared. However, long-term data from the Phase 3 TRAILBLAZER-ALZ 2 study presented at the Alzheimer’s Association International Conference showed that patients reaccumulate amyloid at a rate similar to natural accumulation. John Sims, senior medical director at 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.”
Lilly has begun an addendum study as part of the TRAILBLAZER-ALZ 6 trial to evaluate whether such a maintenance dose can sustain amyloid clearance when given at least one year after initial treatment completion. Sims said this follow-up study has just started enrollment and expects completion early next year. He added, “One of the questions physicians have is: What do we do with these as they come back?” referring to returning amyloid plaques.
Kisunla was approved in July 2024 as an intravenous anti-amyloid antibody intended for discontinuation once minimal levels are reached. This approach provides an alternative for those not seeking life-long treatment but may allow competitors such as Biogen and Eisai—makers of Leqembi—to attract patients finishing their Kisunla regimen. Alisha Alaimo, Biogen’s head of North America, previously said, “Patients in general, who are on either of the products, want to stay on product. There is a fear of coming off and having a decline in their cognition.”
Long-term extension data from TRAILBLAZER-ALZ 2 indicated that patients meeting criteria for ending treatment maintained low levels of amyloid through nearly three years of follow-up. Sims said this rebound matched natural rates seen in people with pre-dementia and suggested a slower process compared with initial disease progression.
At AAIC, Lilly also presented findings supporting a modified titration regimen for Kisunla, which starts at lower doses before ramping up; this approach reportedly reduced cases of brain swelling compared with earlier protocols.
