Authors: Lauren Pulling
Eli Lilly and Company (IN, USA) have today announced that the monoclonal antibody solanezumab has not met the primary endpoint in the EXPEDITION3 clinical trial. The Phase III trial was studying the use of solanezumab in patients with mild dementia due to Alzheimer’s disease (AD).
EXPEDITION3 is a multinational, Phase III trial of solanezumab in over 2100 patients diagnosed with mild dementia due to AD. The study included an 18-month placebo-controlled period followed by an open-label extension, and is the first Phase III trial to evaluate only individuals with mild dementia due to AD.
While some study results, including several secondary endpoints, directionally favored the drug, magnitudes in treatment differences were small and the primary endpoints were not met – results demonstrated that patients treated with solanezumab did not experience a significant slowing in cognitive decline compared with those treated with a placebo.
Cognitive measures were recorded using the ADAS-Cog14 (Alzheimer’s Disease Assessment Scale-Cognitive subscale). As a result of these findings, Eli Lilly will not pursue regulatory submissions for solanezumab as a treatment for mild dementia due to AD.
“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 AD,” said John Lechleiter (chairman, president and chief executive officer, Eli Lilly). “We will evaluate the impact of these results on the development plans for solanezumab and our other Alzheimer’s pipeline assets.”
Next, Ely Lilly aim to conclude the open-label extensions for EXPEDITION, EXPEDITION2 and EXPEDITION3, though the next steps for the remaining elements of the solanezumab development program have not yet been determined.