Lilly drug boosts good cholesterol
Orlando, Florida, November 15, 2011
An experimental heart drug from Eli Lilly and Co dramatically boosted levels of "good" cholesterol and appeared to be safe, according to data from a clinical trial.
The report provides new hope for a class of medicines with a troubled past.
The drug, evacetrapib, increased HDL cholesterol by 53.6 percent at the lowest dose and by a whopping 128.8 percent at the higher dose in the mid-stage study, according to the data, presented at the American Heart Association meeting in Orlando on Tuesday.
It also cut levels of "bad" LDL cholesterol as much as 36 percent when used alone, and as much as 14 percent when taken on top of statins, the widely used pills for lowering cholesterol.
Researchers said evacetrapib showed none of the safety signals found with a similar drug developed by Pfizer. That drug, torcetrapib, also showed robust increases in HDL, but Pfizer stopped development of the medicine in 2006 after it was found to increase deaths.
"This is highly encouraging data that you've got an agent (evacetrapib) that has phenomenal effects on lipids and the safety profile looks clean," said Dr Stephen Nicholls, the study's lead researcher and director of cardiovascular trials at the Cleveland Clinic, who presented the data at meeting in Orlando.
Statins and a raft of blood pressure medicines have dramatically reduced the number of heart attacks and strokes suffered by the population at large. But heart disease remains the No. 1 killer in the world, creating an opening for more effective medicines.
Researchers recommended that evacetrapib begin a large, Phase III study that will show whether the drug prevents heart attacks and stroke.
David Moller, Lilly's head of endocrinology and cardiovascular research, said the company intends to begin its Phase III program "as soon as possible."
Two other so-called CETP drugs -- Merck & Co's anacetrapib and Roche AG's dalcetrapib -- are already being tested among thousands of patients to see if they show such a benefit.
Those drugs are seen as being further along in development than Lilly's version. But Moller said, "At this stage, it's not clear who is going to be first in class or who is going to be best in class."
All of the drugs are designed to block the cholesteryl ester transfer protein, or CETP. Wall Street analysts have said the CETP drugs could reap $10 billion in annual sales, but they are skeptical at the drugs will ever reach the market given the fate of torcetrapib, one of the highest-profile flameouts in the history of drug development. -Reuters