Sanofi and Regeneron's alirocumab was found to be significantly better at lowering levels of LDL cholesterol than ezetimibe (Merck's Zetia) in a late-stage trial, raising hopes that the drug, which is largely being tested in combo with other lipid lowers, also has potential as a standalone agent.
The drugmakers have unveiled data from the Phase III ODYSSEY MONO trial showing that alirocumab - an investigational monoclonal antibody targeting PCSK9 - slashed levels of LDL-C by 47.2% all by itself, a significantly greater reduction than the 15.6% achieved by ezetimibe.
The drug also fared slightly better on the safety side, with 69.2% of patients taking alirocumab reported treatment emergent adverse events compared to 78.4% in the ezetimibe group.
More detailed results from the study are due to be presented an upcoming medical conference next year, but given that previous trials have shown that alirocumab 150mg cut LDL-C by up to 72% when added to the now off-patent blockbuster Lipitor (atorvastatin), there is already growing excitement over its potential, and the inhibition of PCSK9 as a mechanism for lipid management.
Others are also testing PCSK9 inhibitors in trials, including alirocumab's closest rival in the race to market, Amgen's AMG145. Analysts believe that, if successful, PCSK9 blockers could rack up sales of more than $3 billion a year each, reports Reuters.
ODYSSEY MONO is the first study to report data from Regeneron/Amgen's 12 Phase III trials that have been initiated so far as part of the more than 23,000 patient ODYSSEY clinical trial program.