Anthera Pharmaceuticals, a biopharmaceutical developer of drugs to treat diseases associated with inflammation and autoimmune disorders, has announced that the Data Safety Monitoring Board (DSMB) for VISTA-16 clinical trial has recommended stopping the study due to a lack efficacy that could not be reasonably overcome in the remainder of the trial.
The objective of this study was to evaluate the safety and efficacy of short-term varespladib treatment on morbidity and mortality when added to atorvastatin (Lipitor, Pfizer) and standard of care in subjects with an acute coronary syndrome. 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, according to the Hayward, Calif.-based company.
"Based on all the evidence we have seen regarding varespladib and secretory phospholipase and in light of previous study results, we were surprised by the recommendation from the DSMB," said Stephen J. Nicholls, MD, PhD, cardiovascular director of the Cleveland Clinic's Coordinating Center for Clinical Research and chairman of the executive committee overseeing the VISTA-16 trial. "We believed that the study was coming along as expected, and this new information was totally unexpected and disappointing given the potential benefits of this drug."
Based on the DSMB's recommendation, Anthera said it has closed enrollment in the phase 3 VISTA-16 clinical study and informed all investigators to remove patients from therapy immediately.