Eli Lilly has terminated development of its late-stage cardiovascular candidate evacetrapib after it failed to show efficacy in a large-scale trial.
Evacetrapib is a drug in the CETP inhibitor class designed to increase levels of high-density lipoprotein (HDL) cholesterol – which according to some studies has a protective cardiovascular effect.
The decision to terminate the ACCELERATE trial comes after Lilly had already announced a six-month extension to the protocol earlier this year which raised questions about the chances of a positive outcome.
In a statement, the pharma company said the trial’s independent data monitoring committee had recommended halting it “due to insufficient efficacy”, adding that evacetrapib’s development for the treatment of high-risk atherosclerotic cardiovascular disease would now be discontinued.
The news is a big blow to Lilly as it leaves a hole in its late-stage pipeline, even though expectations for the CETP inhibitor class as a whole – once tipped as a blockbuster category – have recently been downsized.
Late-stage failure for Roche’s dalcetrapib and Pfizer’s torcetrapib after safety issues emerged in clinical trials damaged confidence in the category. However, evacetrapib’s failure to show efficacy – even though the drug seemed safe – now suggests prospects are dim.
The outcome also casts a shadow over the other CETP inhibitors that remain in development, including Merck & Co’s anacetrapib – currently in a phase III cardiovascular outcomes study called REVEAL- as well as Bristol-Myers Squibb/Simcere’s BMS-795311 and Dezima’s TA-8995, recently acquired by Amgen.
The decision to discontinue development of evacetrapib will result in a fourth-quarter charge of up to $90m, said Lilly, although chief financial officer Derica Rice said the termination of the programme “does not change our ability to generate long-term growth.”
“Our recent string of positive data-readouts and our strong pipeline position us to grow revenue and expand margins through the remainder of this decade,” he insisted.