Eli Lilly and Co. (LLY) said Monday that pooled data from two late-stage EXPEDITION trials showed its experimental Alzheimer's disease drug solanezumab helped slow cognitive decline, compared with placebo.
In the pre-specified secondary analysis of pooled data, solanezumab had 34 percent less cognitive decline over a span of 18 months, compared with placebo.
In addition, the secondary analysis of the pooled data in patients with mild Alzheimer's disease showed a 17 percent reduction of functional decline, although not statistically significant compared with placebo.
Lilly earlier reported that the study did not meet primary endpoints, both cognitive and functional, in the two Phase 3 placebo-controlled solanezumab EXPEDITION trials in patients with mild-to-moderate Alzheimer's disease.
EXPEDITION 1 trial included 1,012 patients with Alzheimer's and focused on co-primary cognitive and functional endpoints. EXPEDITION 2 focused on a single primary endpoint of cognition. In the studies, patients received either 400 mg of solanezumab infused intravenously or placebo every four weeks for about 18 months, and patients were allowed to remain on stable standard of care.
In the EXPEDITION 1 trial, pre-specified secondary analysis showed that results in patients taking solanezumab demonstrated slowing of cognitive decline compared with placebo, representing a 42 percent reduction in decline at the endpoint of the 18-month study. The difference in functional decline was not statistically significant.
In the EXPEDITION 2 trial, there was a 20 percent reduction in cognitive decline in patients taking solanezumab, while the treatment difference was not statistically significant.
In the EXPEDITION studies, the only adverse event with an incidence of at least 1 percent that occurred statistically significantly more in the solanezumab group was angina. The incidence of vasogenic edema was about 1 percent.
Alzheimer's disease, the most common form of dementia, causes progressive decline in memory and other aspects of cognition. Alzheimer's Disease International estimates that there are currently 35.6 million people with dementia worldwide, with 7.7 million new cases each year. The number of people affected is estimated to be over 115 million by 2050. Experts suggest that as many as 5.4 million Americans may have Alzheimer's disease.
Shares of Eli Lilly are trading at $49.39, up $1.16 or 2.40%, on a volume of 11.5 million shares on the NYSE.
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