Solanezumab (Eli Lilly and Company), a monoclonal antibody being studied as a potential therapy for people with mild cognitive impairment due to Alzheimer's disease (AD), did not meet its primary endpoint in the EXPEDITION3 phase 3 clinical trial. Lilly says it will not pursue regulatory submissions for the medication for the treatment of mild dementia due to AD.
Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo (P = 0.095), as measured by the Alzheimer's Disease Assessment Scale–Cognitive subscale. While the study results, including many secondary clinical endpoints, directionally favored solanezumab, the magnitudes of treatment differences were small. No new safety signals were identified in the study.
"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," said John C. Lechleiter, PhD, Chairman, President, and Chief Executive Officer for Lilly. "We will evaluate the impact of these results on the development plans for solanezumab and our other Alzheimer's pipeline assets."
The 2,100-patient study includes an 18-month placebo-controlled period followed by an open-label extension. Enrollment was completed in 2015, and the last patient visit for the placebo-controlled period occurred in October 2016. Lilly will work with investigators to appropriately conclude the open-label extensions for EXPEDITION, EXPEDITION2, and EXPEDITION3. The next steps for the remaining elements of the solanezumab development program have not been determined.
Lilly will present further findings from the study at the Clinical Trials on Alzheimer's Disease Congress in December.
The EXPEDITION3 study outcome is expected to result in a fourth-quarter charge of approximately $150 million (pre-tax) or approximately $0.09 per share (after-tax).
Source: Eli Lilly; November 23, 2016.