October 13, 2015
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – After Eli Lilly and Company pulled its experimental cholesterol drug on Monday, U.S. heart doctors are now questioning if Merck’s anacetrapib will pass efficacy hurdles, Reuters reported this morning.
P.K. Shah, director of atherosclerosis research at Cedars-Sinai Heart Center in Los Angeles, told Reuters that “"CETP inhibitors as legitimate drug targets are dead as of today.” Shah added that CETP inhibitors are a cardiologist’s dream that has not come true.
On Monday, Indiana-based Eli Lilly said it was accepting the recommendation of an independent data monitoring committee to terminate the Phase III Accelerate trial studying the efficacy of evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease. The independent committee said there was a “low probability the study would achieve its primary endpoint based on results to date. During clinical trials, the drug had shown effective in cutting LDL cholesterol by 30 to 35 percent. Still, the drug did not significantly improve patient’s overall heart health.
Data for Merck & Co. ’s 30,000 study of anacetrapib is not expected until 2017, but early studies for the drug being developed as a selective inhibitor of cholesteryl ester transfer protein (CETP) have shown promise. In mid-stage clinical trials, anacetrapib boosted HDL levels of cholesterol, called the good levels, by 138 percent, while reducing LDL levels by as much as 60 percent, according to The Street. If the drug is approved by the U.S. Food and Drug Administration (FDA), analysts have predicted anacetrapib could generate $10 billion in peak annual sales, Reuters said.
Lilly is not the first drug company to terminate a CETP inhibitor trial. In 2006, Pfizer Inc. terminated its trials for torcetrapib over safety concerns and in 2012, Roche discontinued studies of dalcetrapib for efficacy, Reuters said.
Merck’s is slightly down this morning, trading at $50.67 per share.
The failure of Evacetrapib is also serving as a warning to other drugmakers working on anti-cholesterol developers. In a Monday morning note, Joel Beatty, an investment analyst with Citi Group, said Lilly’s decision could negatively impact Esperion Therapeutics, Inc. development of ETC-1002. Beatty speculated Lilly’s decision could increase the likelihood the FDA will require outcomes trial results for LDL-lowering drugs before approval. In his note, Beatty said evacetrapib’s effectiveness at lowering LDL is at about the same rate as Esperion’s experimental drug.
Both Amgen and Sanofi had anti-cholesterol drugs approved earlier this year, Repatha and Praluent, respectively. Both drugs inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood.
The effects of Repatha and Praluent on cardiovascular morbidity and mortality have not yet been determined. Sanofi is expecting data in 2016 and Amgen is expecting data to be available in 2017.
Stocks for Amgen and Sanofi were both slightly down this morning.
Eli Lilly’s is up slightly this morning, trading at $80.63 per share after it fell 10 percent on Monday following news of evacetrapib’s Phase III trial.
