US development-stage biophama company Anthera Pharmaceuticals (Nasdaq: ANTH) saw its shares plunge as much as 65% to $2.25 in after-hours trading on Friday, when it announced that the Data Safety Monitoring Board (DSMB) has recommended stopping the VISTA-16 clinical study of its cardiovascular drug candidate varespladib due to a lack efficacy that could not be reasonably overcome in the remainder of the trial.
The DSMB's recommendation was based on a review of the totality of the safety and efficacy data available for the VISTA-16 clinical study. Anthera has closed enrollment in the Phase III VISTA-16 clinical study and informed all investigators to remove patients from therapy immediately.
VISTA-16 is an event driven trial evaluating varespladib in combination with Pfizer’s now off patent mega-blockbuster cholesterol lowerer Lipitor (atorvastatin) to reduce secondary major adverse cardiovascular events in patients who recently experienced an acute coronary syndrome. Anthera has worldwide product rights to varespladib, except in Japan where domestic drug major Shionogi retains rights.
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