Amarin Corp plc (AMRN) Completes REDUCE-IT Patient Randomization
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Amarin Corporation plc (Nasdaq: AMRN) announced that randomization of patients into the REDUCE-IT cardiovascular outcomes study has been completed with 8,175 individual patients randomized, in accordance with the study protocol, on a 1:1 basis between Vascepa® (icosapent ethyl) and placebo, slightly exceeding the 8,000 patients targeted for the trial.
The REDUCE-IT study is evaluating whether treatment with Vascepa reduces cardiovascular events in patients who despite stabilized statin therapy have elevated triglyceride levels and other cardiovascular risk factors. Amarin closed enrollment at all global clinical sites in June 2016. Before randomization, patients enrolled in the trial went through a protocol-specified monitoring period to ensure that their LDL-cholesterol was well-controlled on statin therapy and that they were washed out of exclusionary non-statin lipid modifying therapies.
“We are pleased to have completed the randomization of all patients into REDUCE-IT,” said Steven Ketchum, Ph.D., president of R&D and chief scientific officer of Amarin. “Our remaining focus is on ensuring that this important study continues to progress as planned. While we were confident in the design of the study at the target of 8,000 patients, the yield of additional patients from the screening and randomization process is consistent with our efforts throughout this study to ensure that the trial results are robust.”
Amarin continues to expect the onset of the final primary cardiovascular event to occur in the second half of 2017 with publication of trial results likely in 2018. An independent Data Monitoring Committee (DMC) is expected to complete a protocol pre-specified interim efficacy and safety analysis after approximately 60% of the target aggregate primary cardiovascular events have occurred within the study. This interim analysis is most likely to occur in September 2016. A second interim efficacy and safety analysis with approximately 80% of the primary cardiovascular events is expected in mid-2017.
While it is possible that the study could terminate early for overwhelming efficacy at either the 60% or 80% interim analysis, guidelines for the independent DMC to recommend stopping the study for overwhelming efficacy require that the study achieve a high level of statistical significance on the primary endpoint and generate other robust findings including on certain, pre-specified secondary outcome measures to support an overall favorable benefit/risk profile. Given the high threshold of overwhelming efficacy required for a DMC to recommend an early stop to a cardiovascular outcomes trial like REDUCE-IT, Amarin continues to expect that the DMC’s interim analysis will result in a recommendation to continue the REDUCE-IT study as planned. REDUCE-IT is designed for Amarin to remain blinded to results of the study until after the study is stopped at either of the interim analyses or for the final analysis.
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