US drug major Eli Lilly (NYSE: LLY) revealed last Friday that the primary endpoints, both cognitive and functional, were not met in either of the two Phase III, double-blind, placebo-controlled solanezumab EXPEDITION trials in patients with mild-to-moderate Alzheimer's disease. Nevertheless, Lilly’s shares rose 3.4% on Friday to $43.86, as the company indicated that the drug showed some potential to help in mild cases of the disease.
It said that a pre-specified secondary analysis of pooled data across both trials showed statistically significant slowing of cognitive decline in the overall study population of patients with mild-to-moderate Alzheimer's. In addition, pre-specified secondary subgroup analyses of pooled data across both studies showed a statistically significant slowing of cognitive decline in patients with mild disease, but not in patients with moderate Alzheimer's.
This is the second AD disappointment this month: Pfizer and Johnson & Johnson said they will drop development of bapineuzumab, an intravenous version of their potential Alzheimer's treatment, after two late-stage studies showed it worked no better than a placebo in patients with mild-to-moderate cases (The Pharma Letter August 7).
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