Eli Lilly and Company’s Phase III EXPEDITION3 trial of solanezumab fails to meet primary endpoint
Eli Lilly and Company has reported that it’s Phase III EXPEDITION3 clinical trial of solanezumab failed to meet its primary endpoint in treating people with mild dementia due to Alzheimer's disease (AD).
Lilly's solanezumab is a phase III, humanised monoclonal IgG1 antibody developed against the mid-domain of the Aβ peptide.
The multinational, phase III EXPEDITION3 trial has examined more than 2,100 patients diagnosed with mild dementia due to Alzheimer's disease.
It includes an 18-month placebo-controlled period with a follow-on open label extension.
Results suggested that after being administered to patients, solanezumab did not result in a significant slowing in cognitive decline compared to patients treated with placebo determined on the basis of Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog).
Lilly president and CEO John Lechleiter said: "The results of the solanezumab EXPEDITION3 trial were not what we had hoped for and we are disappointed for the millions of people waiting for a potential disease-modifying treatment for Alzheimer's disease.
"We will evaluate the impact of these results on the development plans for solanezumab and our other Alzheimer's pipeline assets."
The company will work with the investigators for an appropriate completion of EXPEDITION, EXPEDITION2 and EXPEDITION3 and will drop plans of regulatory submissions for solanezumab for the treatment of mild dementia due to Alzheimer's disease.