Here is some analysis and perspective, not to mention a few burning questions, about the Phase 2 data Eli Lilly disclosed on its experimental Alzheimer’s therapy donanemab on Saturday.
STAT earlier asked five independent scientists involved in Alzheimer’s research about the study; unsurprisingly, their opinions were quite mixed, with the data representing a Rorschah test for their views on Alzheimer’s drug development. The study was also published in the New England Journal of Medicine.
Lilly has already answered a few major questions about Trailblazer-Alz 2, an ongoing Phase 3 trial that will test donanemab in a larger group of patients. That study will now enroll up to 1,500 people, nearly tripling its previously planned size, Lilly said on a conference call Monday. The company also changed the primary endpoint of the trial from a cognitive test preferred by the Food and Drug Administration to the Lilly-developed metric used in the successful Phase 2 study.
“argues that it might have been ARIA-induced patient dropouts and not the drug. ” I would argue the exact opposite. ARIA is a sign that amyloid is being removed & ApoE4 patients progress faster. Pts progressing faster allows more opportunity to separate tx effect of drug vs PBO. those ARIA droputs may have hurt the efficacy, and may be the reason that the curves stopped separating