This post was published on ZYX Short Sell Change Alert
The stock is likely to be very volatile, conservative investors should not enter this trade. The results of the trial are being misinterpreted by some in the market. Here are the details.
LLY announced that the primary endpoints, both cognitive and functional, were not met in either of the two Phase 3, double-blind, placebo-controlled solanezumab EXPEDITION trials in patients with mild-to-moderate Alzheimer’s disease. However, 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 disease. 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 Alzheimer’s disease, but not in patients with moderate Alzheimer’s disease. Adverse events with an incidence of at least 1% that occurred statistically significantly more in the solanezumab group than in the placebo group were lethargy, rash and malaise in EXPEDITION1 and angina in EXPEDITION2. An ongoing, open-label extension study, EXPEDITION-EXT, is fully enrolled and will continue as planned. “We recognize that the solanezumab studies did not meet their primary endpoints, but we are encouraged by the pooled data that appear to show a slowing of cognitive decline,” said John C. Lechleiter, Ph.D., chairman, president and CEO, Lilly. “We intend to discuss these data with regulatory authorities to gain their insights on potential next steps.”
Eli Lilly says primary endpoints not met in two trials of solanezumab.
