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Sanofi and Regeneron Report Positive Preliminary Phase 2 Program Results for Anti-PCSK9 Antibody in Hypercholesterolemia
Date:11/9/2011

st-treatment monitoring period will be presented at a future medical congress upon final analysis.

Another Phase 2 trial studied patients with primary hypercholesterolemia with elevated cholesterol (LDL-C>/= 100mg/dL) who were on a stable low dose of atorvastatin (10 mg).  The primary objective of the study was to compare the effect of switching to a high dose of atorvastatin alone (80mg) versus a high dose of atorvastatin combined with REGN727/SAR236553.  In the primary endpoint of the study, after eight weeks of treatment, patients who received REGN727/SAR236553 plus atorvastatin 80mg achieved a greater than 65% reduction in mean LDL-C compared to a mean reduction of 17% for atorvastatin 80mg only (p<0.001).  The study also included a third arm in which REGN727/SAR236553 was added to the stable low dose of atorvastatin and the patients achieved a greater than 65% reduction in mean LDL-C.  Patients in the study were followed for a total of 16 weeks for safety.

In this trial, REGN727/SAR236553 was generally well tolerated over 16 weeks.  There was one serious adverse event of dehydration in the REGN727/SAR236553 + atorvastatin 80mg group that was deemed not treatment related.  One patient in the REGN727/SAR236553 + atorvastatin 80mg group with mildly elevated AST prior to randomization (>ULN and </= 3ULN) experienced an elevation of AST>3ULN and </=5ULN and one patient discontinued therapy due to a hypersensitivity reaction (rash).

A third study of this Phase 2 program is still ongoing.

"The preliminary Phase 2 results with our anti-PCSK9 antibody are very encouraging," said Elias Zerhouni, President, Global Research & Development, Sanofi.  "We look forward to analyzing and presenting the complete data set and remain committed to advancing this program into Phase 3 development as soon as possible."

"Despite the availability of statins, elevated cholesterol and coronary artery
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SOURCE Regeneron Pharmaceuticals, Inc.
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