Mid-stage study data presented Tuesday at the American Heart Association Scientific Sessions indicated that Eli Lilly's experimental CETP inhibitor evacetrapib boosted HDL cholesterol levels whilst simultaneously lowering LDL cholesterol levels in patients. "We got everything we could hope for from this drug, and maybe more," remarked study co-author Steven Nissen, adding that "we are going to move evacetrapib forward as rapidly as possible" into a late-stage trial.
David Moller, vice president at Eli Lilly, noted that the company plans to meet with regulators "in the very near future" to discuss starting a Phase III study, which would aim to show that evacetrapib reduces heart attacks and cardiovascular deaths when given with standard cholesterol-lowering therapy. "We feel we have a very competitive molecule," Moller said.
Evacetrapib belongs to the same class of drugs as Pfizer's torcetrapib, studies of which were halted in 2006 after elevated blood pressure was seen in patients taking the drug. Merck & Co. and Roche are also developing CETP inhibitors, with their respective compounds, anacetrapib and dalcetrapib, already in late-stage development. "These could be as big as the statins were 20 years ago" if the data continue to be positive, Nissen remarked.
In the latest study, 393 patients with elevated LDL or low HDL cholesterol levels with an average age of 59 years were assigned to one of 10 groups, investigating three doses of evacetrapib alone and in combination with AstraZeneca's Crestor (rosuvastatin), Pfizer's Lipitor (atorvastatin) or simvastatin. After 12 weeks of therapy, HDL cholesterol levels in patients taking Eli Lilly's drug rose by between 53.6 percent and 128.8 percent compared with placebo, while LDL cholesterol levels fell by between 13.6 percent and 35.9 percent. The results, which were also published in JAMA, showed that blood cholesterol results improved as the dose of evacetrapib increased, while levels of triglycerides falling 16 percent at the highest dose tested compared to placebo.
Further, results demonstrated that patients taking a 100 milligram daily dose of evacetrapib in combination with a statin had an increase in HDL cholesterol levels of between 78.5 percent and 88.5 percent, with LDL cholesterol levels dropping by between 11.2 percent and to 13.9 percent. The data indicated that the changes in cholesterol levels associated with evacetrapib were significantly greater than those observed in patients taking statins alone. In addition, unlike in trials of torcetrapib, Eli Lilly’s drug didn’t raise blood pressure or levels of aldosterone or cortisol.
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