Harris James Associates Compiled News: Anthera Pharmaceuticals Successfully Completes Interim Biomarker Analysis

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Anthera Pharmaceuticals Successfully Completes Interim Biomarker Analysis of VISTA-16 Study and Third Safety Review of Varespladib Methyl
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VISTA-16 Study to Continue Global Enrollment
HAYWARD, Calif., April 18, 2011 /PRNewswire/ — Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced that enrollment in the Phase 3 VISTA-16 study of varespladib in Acute Coronary Syndromes (ACS) will continue based on the positive outcome of an interim biomarker analysis and review of available patient safety data.
An independent statistician completed an analysis of various biomarkers of cardiovascular risk and determined that treatment with once-daily varespladib met the pre-specified criteria for the study to proceed. The analysis required patients on varespladib to demonstrate pre-defined treatment effects versus placebo at relevant time points on a collection of biomarkers including: secretory phospholipase A2 (sPLA2), low density lipoprotein cholesterol (LDL-C), C-reactive protein (CRP), interleukin-6 (IL-6), and a composite responder endpoint defined as patients achieving LDL-C less than 70 mg/dL and CRP below 1.0 mg/L.
In parallel with the biomarker analysis, the VISTA-16 independent Data Safety and Monitoring Board (DSMB) completed a review of the available safety database including all reported adverse events and serious adverse events and recommended the continuation of the VISTA-16 clinical study without modification. This represents the third meeting of DSMB since the start of the study.
“We continue to believe that positive changes in patient biomarkers similar to changes seen in the FRANCIS Phase 2 clinical study will correlate to a reduction in major adverse cardiovascular events in patients treated with varespladib for 16 weeks,” said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals. “We are hopeful this approach will eventually prove that rapid and safe reduction of inflammation following an acute coronary syndrome will translate into better treatment options for this high-risk patient population.”
“VISTA-16 represents an innovative approach based on years of extensive study of the negative effects of inflammation in patients with ACS”, commented Stephen J. Nicholls, M.D., Ph.D., Cardiovascular Director of C5 Research at the Cleveland Clinic and Chairman of the VISTA-16 Executive Committee.