The Japanese drugmaker is set to present the findings from a Phase 3 clinical trial evaluating lecanemab as a treatment for people with early Alzheimer’s disease on Tuesday at 4:50 p.m. Pacific time at the Clinical Trials in Alzheimer’s Disease (CTAD) annual meeting in San Francisco.
Preliminary clinical data show that lecanemab can slow cognitive decline in patients in the early stages of Alzheimer’s diseases by 27%, a finding that sent shares in the two companies soaring — and raised the hopes of healthcare providers and of families of people with the neurological disease.
Eli Lilly & Co.’s
donanemab is currently in late-stage clinical trials, as well.
“There remains a healthy amount of debate into CTAD in terms of the details/nuances of lecanemab’s clinical profile, which could have a meaningful impact on reimbursement and potential competitive differentiation, should [Lilly’s] donanemab be successful,” UBS Securities analyst Colin Bristow wrote in an investor note on Monday.
Wall Street analysts will look at the data for lecanemab to learn how long the drug remains effective, what the reported deaths of two patients in the trial mean and whether certain high-risk patients should be excluded from receiving the drug if it is approved. (Science magazine reported Sunday that a 65-year-old woman in the study died from a brain hemorrhage “that some researchers link to the drug.”)
“It is plausible that receiving a beta-amyloid antibody like lecanemab could increase susceptibility to intracranial hemorrhage from blood thinners (as was also the case with the first reported lecanemab death …) or if there are predisposing factors such as amyloid angiopathy or pre-existing microhemorrhages,” RBC Capital Markets analyst Brian Abrahams told investors on Monday.
However, Abrahams believes lecanemab will be approved by the Food and Drug Administration and will eventually hit peak annual sales of $9.5 billion.
Here’s what else to watch for coming out of CTAD this week:
Axsome Therapeutics Inc.
reported good news on Monday, saying its Alzheimer’s treatment candidate met the primary and secondary endpoints in a Phase 3 clinical trial, with the drug delaying the time to relapse and preventing agitation among patients. The therapy, AXS-05, was tested in a double-blind, placebo-controlled, randomized study that enrolled 178 patients. There are no approved treatments for agitation caused by Alzheimer’s.
is expected to share additional data about the Alzheimer’s treatment it developed with MorphoSys
The companies announced earlier this month that gantenerumab did not reduce cognitive decline in a statistically significant way or clear the amyloid plaques commonly found in the brains of people diagnosed with the disease in a pair of Phase 3 clinical trials. Roche is set to present at 4:15 p.m. Pacific time on Wednesday.
Also on Wednesday, Lilly will share data from a study comparing donanemab with Aduhelm, the controversial Alzheimer’s drug brought to market by Eisai and Biogen in 2021. That presentation is scheduled for 3 p.m. Pacific time.