Eli Lilly said that donanemab, an investigational antibody, showed a 32% reduction in a composite measure of cognition and daily function in trial patients suffering early symptomatic Alzheimer's disease following Phase 2 trials. Eli Lilly had said on January 11 that the 32% decline rate, compared to placebo, was 'statistically significant' and met the primary endpoint of the phase 2 'Trailblazer' ALZ study.
Alzheimer's disease, a progressive brain disorder, affects more than 50 million people around the world. To date, no drug has been found to address the disease, which can accelerate into dementia and other more serious cognitive conditions.
"Given our conversations with investors when the data first came out, it was clear that expectations were relatively high, which seemed strange to us given the lack of the detailed data and the continuous disappointments in the AD space," said SVB Leerink analyst Marc Goodman. "Given our critical view of the full data set, we do think that the totality of the TRAILBLAZER-ALZ data is still supportive of the anti-Abeta hypothesis, given the significant Abeta clearance and consistently positive trend across several important endpoints, but demonstrating correlation with cognitive endpoints with a prespecified endpoint will still be a challenge."
"We look forward to Lilly’s conference call (today) about the data, as at the AD/PD meeting Lilly did not disclose potential reasons why some secondary endpoints did not hit at later timepoints," he added.
Eli Lilly shares were marked 8.3% lower in early trading Monday to change hands at $190.77 each, a move would trim the stock's six-month gain to around 27%.