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 onlypeople
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.
Source : DNA -27th November,2016
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