Eli Lilly says it hasn’t yet decided on the future of its Alzheimer’s disease (AD) candidate solanezumab, despite the drug failing to meet either cognitive or functional primary endpoints in both of its Phase III Expedition trials in patients with mild-to-moderate disease. The firm is clinging onto data emerging from a prespecified secondary analysis of pooled results from both the Expedition1 and Expedition2 trials, which showed that treatment with the anti-amyloid beta monoclonal antibody solanezumab resulted in a statistically significant slowing of cognitive decline in patients with mild AD, but not those with moderate AD.
Lilly says these findings are the first from a Phase III study to indicate that an anti-beta amyloid agent may help slow cognitive decline. “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,” comments John C. Lechleiter, Ph.D., chairman, president and CEO. “We intend to discuss these data with regulatory authorities to gain their insights on potential next steps.”
The two 18-month placebo-controlled Expedition studies included over 2,050 patients with mild-to-moderate AD in 16 countries. An open-label extension to the studies is now fully enrolled and will continue, Lilly states.