Alirocumab: Phase III data
Top-line data from the double-blind, international Phase III ODYSSEY COMBO I, COMBO II, OPTIONS I and OPTIONS II trials in patients with hypercholesterolemia and high cardiovascular risk who were not adequately controlled with lipid-lowering therapy showed that subcutaneous alirocumab met the primary endpoint in all of the trials of reducing LDL-C from baseline to week 24 vs. placebo or an active comparator. COMBO I enrolled about 306 patients and compared alirocumab to placebo; COMBO II enrolled about 660 patients and compared alirocumab to ezetimibe; OPTIONS I enrolled about 350 patients receiving atorvastatin and compared alirocumab to up-titration of atorvastatin, atorvastatin plus ezetimibe or a switch from atorvastatin to rosuvastatin; and OPTIONS II enrolled about 300 patients receiving rosuvastatin and compared alirocumab to up-titration of rosuvastatin or rosuvastatin plus ezetimibe. Alirocumab was generally well tolerated with nasopharyngitis and upper respiratory tract infections reported as the most common adverse events.
Sanofi and Regeneron previously reported data from the Phase III ODYSSEY MONO trial in 103 patients with primary hypercholesterolemia and moderate cardiovascular risk showing that alirocumab met the primary endpoint of reducing mean LDL-C from baseline to week 24 vs. ezetimibe (47.2% vs. 15.6%, p<0.0001) (see BioCentury, Oct. 21, 2013 & April 7, 2014). Data from the Phase III ODYSSEY FH I, FH II, HIGH FH, LONG TERM and ALTERNATIVE trials were also reported last week. ...