A Cholesterol Drug Fail To Perform Well. On Monday, drug maker Eli Lilly announced that it was ceasing work on a new cholesterol-lowering drug, after the drug failed to perform well in a phase 3 clinical trial.
The drug, evacetrapib, was designed to prevent heart attacks and other cardiovascular problems by modifying cholesterol levels, the Wall Street Journal reports.
Interim results from a large clinical trial showed that evacetrapib was not likely to significantly reduce cardiovascular risk compared to a placebo, despite having the desired cholesterol-lowering effect. Lilly said the decision to halt the trial was not based on safety findings, according to the WSJ.
Evacetrapib is one of new class of drugs—cholesterol esterase transfer protein (CETP) inhibitors. CETP inhibitors are designed to lower LDL (“bad”) cholesterol. Thus far, Medscape reports, this class of drugs has had disappointing results for the drug makers. Previous CETP inhibitors torcetrapib and dalcetrapib were both pulled from the pipeline. In a large trial, torcetrapib showed an increased risk of mortality and cardiovascular events and dalcetrapib failed to show a benefit.
FDA Drug Approval
A phase 3 trial is the third of four phases in Food and Drug Administration (FDA) drug approval: the drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. ACCELERATE, a phase-3 randomized trial for evacetrapib, had enrolled 12,095 patients in 37 countries with diabetes, a history of acute coronary syndrome, statin-resistant dyslipidemia, and other high-risk features. The study followed the patients for the composite end point of CV death, heart attack, stroke, revascularization (stent or catheterization), or hospitalization for unstable angina. Medscape reports that the trial was scheduled to continue for another year, but the safety monitoring board recommended that it 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 a statement from Lilly.
Lilly’s stock plummeted after the announcement, the WSJ reports. Until the announcement, Lilly has been showing signs of recovering from a series of patent expirations that significantly decreased sales of older medicines like Zyprexa and Cymbalta for mental illnesses. Once a patent expires, other drug makers can enter the market with a generic version of the drug, eating into sales and bringing down the price of the brand name drug. Since the beginning of 2014, Lilly has won regulatory approval to market three new drugs, and several experimental treatments under development look promising. This helped move Lilly’s shares to a 10-year high last month, but Monday’s evacetrapib announcement caused shares to drop by 7.8 percent. Lilly is awaiting regulatory decisions on potential new drugs for lung cancer and psoriasis, and it is involved in late-stage studies of drugs for arthritis and breast cancer.
Lilly has avoided the megamergers undertaken by some of its rivals. The company’s chief executive, John Lechleiter, said he feels big mergers in the past disrupted research efforts. But for a smaller company, the failure of even one drug can have a big impact of the company’s financial outlook. And the WSJ points out that larger drug makers have the advantage of a cushion Lilly does not have when difficulties arise in their research and development efforts.