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Lilly Ends Development of Experimental Cholesterol Drug
Eli Lilly and the ACCELERATE study’s academic leadership have decided to terminate the phase III trial of evacetrapib as a result of a recommendation by an independent data monitoring committee. Evacetrapib was being studied for the treatment of high-risk artherosclerotic cardiovascular disease (ASCVD).
According to Lilly, the independent data monitoring committee based its recommendation on periodic data reviews that suggested there was a low probability the study would achieve its primary endpoint. The study is not being stopped because of safety findings. After further analysis, results of the study will be presented at scientific forums in the future.
The ACCELERATE study was designed to evaluate the efficacy and safety of evacetrapib in ASCVD patients. The pivotal phase III trial — Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High Risk for Vascular Outcomes — was designed as a randomized, double-blind, placebo-controlled trial being conducted at 540 sites in 37 countries, with 12,095 patients enrolled.
The primary outcome measure was designed to be time to first occurrence of any component of the composite cardiovascular events of cardiovascular death, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina.
The decision to discontinue development of evacetrapib is expected to result in a fourth-quarter charge to research and development expense of up to $90 million (pretax), or approximately $0.05 per share (after tax). Lily will incorporate this estimated charge into its updated 2015 guidance, which will be provided as part of its third-quarter 2015 earnings announcement on Thursday, Oct. 22.
The Wall Street Journal reported that Lilly’s own expectations for evacetrapib had been tempered by past failures of similar drugs from other companies — most notably Pfizer’s 2006 halt to a study of torcetrapib because of safety woes. But more recently the company and its investors had become more optimistic that evacetrapib would work.
Sources: Eli Lilly; October 12, 2015; The Wall Street Journal; October 12, 2015.