December 2, 2016
Lessons Learned from Recent Failed Drug Trial
According to a recent press release from drug manufacturer Eli Lilly, Solanezumab, did not produce a statistically significant benefit as compared to placebo (no drug) in a recent clinical trial titled, Expedition3. Trends on several measurements favored solanezumab over placebo but the differences were small. Researchers found no safety concerns.
Expedition3, a multinational Phase 3 Study, involved over 2,100 patients diagnosed with mild Alzheimer’s dementia. Solanezumab is an experimental monoclonal antibody therapy intended to target the build-up of beta-amyloid protein in the brain which scientist suspect is a culprit in the development of Alzheimer’s disease.
So What Does this Mean?
According to Cleveland Clinic Lou Ruvo Center for Brain Health Director, Dr. Jeffrey Cummings, patients in the early stage of the disease (those with mild Alzheimer’s) have had the Alzheimer’s protein building up in the brain for many years. Therefore, it may be necessary and more beneficial to administer the treatment earlier in the disease course. In the ongoing, nationwide A4 study, Solanezumab is being tested in over 1,000 participants who are not experiencing memory symptoms but are believed to be at an increased risk of developing the disease.
“Although the results of the Expedition3 study are disappointing, there is an enormous amount of important knowledge gained from each trial, no matter the outcome. We will learn more as the trial results are more thoroughly analyzed,” said Dr. Cummings.
“More importantly”, added Dr. Cummings, “the need to find new treatments for Alzheimer’s disease is urgent and the search will not stop because of this set-back. We owe all clinical trial participants and their families; past, present and future, tremendous gratitude for their contribution towards Alzheimer’s research. We must learn from each trial and continue to move forward.”