INDIANAPOLIS, IN — The company behind the cholesterol esterase transfer protein (CETP) inhibitor evacetrapib will no longer be behind it. Eli Lilly announced today that it will stop development of the lipid-modifying drug after independent monitors urged a halt to the ACCELERATE phase 3 randomized trial in patients with "high-risk" coronary artery disease, due to "insufficient efficacy," the company announced today.
CETP inhibitors are a closely watched class of agents with potent LDL-lowering prowess but a disappointing development history. The first drug in the class to reach advanced clinical testing, torcetrapib, was pulled out of the pipeline after a large trial revealed an increased risk of mortality and cardiovascular events. Another drug in the family, dalcetrapib, failed after an interim analysis of a major outcomes trial showed no benefit.
ACCELERATE, conducted at 540 sites in 37 countries, had enrolled 12,095 patients with diabetes, a history of acute coronary syndrome, statin-resistant dyslipidemia, and other high-risk features. It was following them for the composite end point of CV death, MI, stroke, revascularization, or hospitalization for unstable angina. It had been scheduled to go on for another year.
However, the trial's data safety monitoring board recommended the trial be stopped based on a prespecified data review that "suggested there was a low probability the study would achieve its primary end point based on results to date," according to Lilly. "The study is not being stopped for safety findings," it said in its announcement aimed at the investment community.
Heartwire from Medscape © 2015 Medscape, LLC
Cite this: Lilly Pulls Plug on Its CETP Inhibitor Evacetrapib - Medscape - Oct 12, 2015.