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Alzheimer’s Drug Fails to Meet Primary Endpoints in Phase III Trials
However, a prespecified 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 AD. 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 AD but not in patients with moderate AD.
Adverse events with an incidence of at least 1% that occurred statistically significantly more in the solanezumab group than in the placebo group included lethargy, rash, malaise, and angina.
An ongoing, open-label extension study, EXPEDITION-EXT, will continue as planned.
An independent analysis of the data from the EXPEDITION studies is being performed by the Alzheimer's Disease Cooperative Study (ADCS), an academic national research consortium that facilitates the discovery, development, and testing of new drugs for the treatment of AD. ADCS will present its findings at the American Neurological Association (ANA) meeting in Boston, Mass., on October 8, 2012, and at the Clinical Trials on Alzheimer's Disease (CTAD) meeting in Monte Carlo, Monaco, on October 30, 2012.
The next steps for solanezumab have not yet been decided and will be determined after discussions with regulators.
For more information, visit the Eli Lilly Web site.