Amarin Corporation plc (AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, today announced that the last patient study visit has occurred in its potential landmark cardiovascular outcomes study, REDUCE-IT™. The company also reiterated that it anticipates having top-line results for this important study reported before the end of Q3 2018.
REDUCE-IT Status Update
In March 2018, patients commenced their last study visits as participants in the REDUCE-IT study. Completion of last patient visits is an important step towards finalizing the REDUCE-IT study and announcing results. As previously described, other important steps needed to complete the study include finalizing adjudication of reported events, including major adverse cardiovascular events (MACE) within the primary endpoint, securing final vital status data from inactive patients, and completing the review of data for consistency and completeness across more than 35,000 patient years in the trial.
The company reported that adjudication of all identified potential endpoints is approaching completion. As part of their last site visits in the study, patients underwent non-invasive diagnostic testing to determine whether silent myocardial infarctions or other clinical events had occurred. Until this testing was completed at the last patient visits, some cardiovascular events could not be finally adjudicated, even if these potential study endpoints occurred much earlier in the trial.
As is typical of large, multi-national, long-term outcomes studies, the final steps preceding REDUCE-IT completion include resolving remaining queries to contribute to a robust and accurate database. This “cleaning” process is characteristically intensive and time consuming. Progress is being made at a pace consistent with the company’s guidance of having top-line results to report before the end of Q3 2018.
Amarin continues to be intentionally blinded to the results of the study and will remain blinded to such results until after the study is completed and the database is locked.
Communication of REDUCE-IT Progress and Results
The series of steps being followed to complete the REDUCE-IT study is intended to support a robust understanding and reporting of results from this potentially landmark study. Amarin is highly motivated to announce the REDUCE-IT top-line results as soon as is practical. In parallel, the company is continuing its preparations for commercial expansion on the assumption of positive study results.
Once the REDUCE-IT database is locked, consistent with other outcomes studies, the company and a team of experts plan to confidentially review and analyze the data and promptly announce top-line results publicly. Broader reporting of results is targeted for a scientific conference in Q4 2018. The time between the database lock and reporting top-line results is intended to be as brief as is possible to support both timely and accurate reporting of the results. Consistent with the practices of most other companies, it is unlikely that Amarin will separately announce the date the database is locked. Rather, the company will focus on reporting the top-line results promptly after top-line results are known following database lock.
The time between commencing last patient study visits and reporting top-line results in other large outcomes studies reviewed by the company has been approximately five to seven months. There is no reliable correlation between the length of time needed to wind down a study (i.e., the time interval between commencement of patient last site visits and reporting top-line results) and the outcome of reported results of a study. Amarin’s anticipation of reporting top-line results before the end of Q3 2018 is consistent with the wind-down timing of these other outcomes studies, each of which were conducted by companies much larger than Amarin.