Amarin slips after adding second interim efficacy trial to PhIII CV trial

FDA sign

Investors knocked a few percentage points off Amarin’s ($AMRN) share price after the firm added a second interim analysis to its Phase III cardiovascular disease trial. Amarin sees the second look at the data as an opportunity to accelerate the final analysis, but, in changing the protocol, it appears to have alarmed some investors. 

Amarin had already planned to conduct an interim data analysis once 60% of the 1,612 cardiovascular events the trial is slated to include have occurred. Now, Amarin has changed the protocol to add a second interim analysis that will take place once 80% of the events have happened. Amarin is hoping the second analysis will allow it to wrap up the final analysis faster once the trial of its omega-3 drug Vascepa is fully complete. Neither of the interim looks at the data feature a futility analysis.

“Because of this important unmet clinical need, the opportunity it presents and the years invested in this study, our goal is to promptly report and broadly publish the multiple findings anticipated from the study,” Amarin CSO Steven Ketchum said in a statement. “We remain confident that REDUCE-IT is positioned for success.”

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Some investors seem to have felt less confident than Ketchum following the protocol amendment. Shares in Amarin fell by as much as 10% in premarket trading. As the day wore on, cooler heads prevailed, resulting in the stock climbing out of its slump.

The first of the analyses is pencilled in for sometime in September or October, although the exact date will depend on the rate at which cardiovascular events occur. Top-line data from the whole trial are due in 2018.

- read the release

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