Eli Lilly said that it and the ACCELERATE study’s academic leadership have accepted the recommendation of the independent data monitoring committee to terminate its Phase 3 trial of the investigational medicine evacetrapib. The reason was insufficient efficacy.
The company announced in its press release that it will now discontinue development of evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease. The drug giant also said that it will now conclude other studies in the program.
It turns out that periodic data reviews suggested that there was a low probability the study would achieve its primary endpoint, and that was based on the trial results that have been seen so far. Lilly said:
The study is not being stopped for safety findings. After further analysis, results of the study will be presented in scientific forums in the future.
Another issue is that the company said it plans to work with investigators to appropriately conclude these trials. This decision to discontinue development will result in a fourth-quarter pretax charge to research and development expense of up to $90 million, or approximately $0.05 per share.
Eli Lilly shares were down over 9% at $78.20 in active premarket trading Monday, as well as down more than 8% just after the opening bell. Its consensus price target was $97.11 prior to the news, and its 52-week range is $60.58 to $92.85.
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