Enrollment was completed in 2015 and the last patient visit for the placebo-controlled period was in October 2016.
Solanezumab, a drug anticipated to potentially aid patients suffering from Alzheimer’s has failed clinical trials, pharma major Eli Lilly on Saturday. A release stated that it did not meet the primary endpoint in the phase three clinical trials of people with mild dementia due to Alzheimer’s disease (AD). Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo.
More than 2,100 patients diagnosed with mild dementia due to Alzheimer’s disease were enrolled across countries in a study that lasted over eighteen months. Enrollment was completed in 2015 and the last patient visit for the placebo-controlled period was in October 2016. It was the first phase 3 trial to evaluate only people with mild dementia due to Alzheimer’s disease.
While the study results, including many secondary clinical endpoints, directionally favoured solanezumab, the magnitudes of treatment differences were small. There were no new safety signals identified in the study. Lilly will not pursue regulatory submissions for solanezumab for the treatment of mild dementia due to Alzheimer’s disease. “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, Lilly.
“We will evaluate the impact of these results on the development plans for solanezumab and our other Alzheimer’s pipeline assets,” he said.“Lilly is grateful for the dedication of the patients, their families, and the clinical investigators who participated in this study,” said Jan Lundberg, PhD, Executive Vice President of science and technology and President, Lilly Research Laboratories.
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