Amarin Corporation plc (ADR)(NASDAQ:AMRN) reported that the data monitoring committee has completed its assessment of the planned pre-specified interim safety and efficacy evaluation for the REDUCE-IT cardiovascular outcomes trial and has recommended that the study continue as planned without any changes.
As REDUCE-IT is the preliminary prospective clinical study of any treatment in the large patient population assessed, the bars for stopping this study early for overwhelming efficacy were set high with the understanding that a stronger result, dependent on a larger count of cardiovascular events, could be acquired by the trial continuing to completion.
Data from the completed trial are anticipated in the quarter second or third of 2018. The 8,175-subject outcomes trial is assessing whether treatment with Vascepa® lowers major adverse cardiovascular events in subjects who despite stabilized statin treatment have higher triglyceride levels and other cardiovascular threat elements.
As per the trial protocol, this preliminary efficacy analysis was conducted after adjudication of almost 80% of the target 1,612 total primary cardiovascular events happened within the trial. Arrangements for a final efficacy assessment will be led by the onset of around 100% of the target total count of primary cardiovascular events.
Amarin projects that the onset of around 100% of events will likely happen in early 2018. The company is intentionally blinded to the preliminary analysis data and will stay blinded to data of the trial until after the trial is halted and the file is locked at the final assessment.
The DMC’s suggestion to continue as planned also highlights its assessment of all accessible safety data. As per the trial protocol and DMC charter, safety assessments have been performed numerous times each year since Amarin’s REDUCE-IT started in December 2011, and over 30,000 patient years of trial have been collected to date in the underway REDUCE-IT study. The recommendation and review of the DMC at this preliminary look were made independently. Neither FDA nor Amarin has assessed the interim clinical data.