ASCVD drug trial terminated due to insufficient efficacy

US healthcare company Eli Lilly and Company (Lilly) will terminate its phase 3 trial of the investigational medicine evacetrapib — and, in turn, development of the drug itself —  due to insufficient efficacy. The study was designed to evaluate the efficacy and safety of evacetrapib in participants with high-risk atherosclerotic cardiovascular disease (ASCVD).

The phase 3 trial, named ACCELERATE, was designed as a multicentre, randomised, double-blind, placebo-controlled trial 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 revascularisation or hospitalisation for unstable angina.

The independent data monitoring committee which recommended the study’s termination based its proposal on data from periodic data reviews, which suggested there was a low probability the study would achieve its primary endpoint based on results to date. Safety findings played no part in the decision.

“We’re obviously disappointed in this outcome, as we hoped that evacetrapib would offer an advance in treatment for people with high-risk cardiovascular disease,” said David Ricks, Lilly senior vice president and president of Lilly Bio-Medicines. “We’ll be working with investigators to appropriately conclude these trials.”

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 (pre-tax), or approximately $0.05 per share (after tax). The company will incorporate this estimated charge into its updated 2015 guidance, which will be provided as part of its third-quarter 2015 earnings press release on 22 October.

“This unfortunate outcome for evacetrapib does not change our ability to generate long-term growth,” said Derica Rice, Lilly executive vice president and chief financial officer. “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.”

Results of the ACCELERATE study will be presented in scientific forums in the future.