- Phase 3 study shows solanezumab didn’t meet the primary endpoint in the EXPEDITION3 clinical trial for the treatment of mild dementia due to Alzheimer's disease.
Eli Lilly announces that solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial for the treatment of mild dementia due to Alzheimer's disease :
Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo (p=.095), as measured by the ADAS-Cog14 (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.
- There were no new safety signals identified in the study.
- Co will not pursue regulatory submissions for solanezumab for the treatment of mild dementia due to Alzheimer's disease.
- Co 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 yet been determined.
- The EXPEDITION3 study outcome is expected to result in a fourth-quarter charge of ~$150 million (pre-tax), or ~$0.09/share (after-tax).
- The company will provide updated 2016 financial guidance and announce its 2017 financial guidance on December 15, 2016
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