PARIS (dpa-AFX) - French drug maker Sanofi (SNYNF, SNY) and U.S.-based Regeneron Pharmaceuticals, Inc. (REGN) announced Wednesday that nine new Phase 3 ODYSSEY trials of alirocumab in people with hypercholesterolemia met their primary efficacy endpoint.
According to the companies, the primary goal was of a greater percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at 24 weeks compared to placebo or active comparator.
Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9).
In the nine ODYSSEY trials, the mean percent reduction in LDL-C from baseline at 24 weeks in alirocumab-treated patients was consistent with results seen in previous alirocumab trials. All patients received alirocumab in addition to standard-of-care lipid-lowering therapy, with the exception of some patients in ODYSSEY ALTERNATIVE.
The company noted that Alirocumab was generally well tolerated in the 9 ODYSSEY trials. The most common adverse events were nasopharyngitis and upper respiratory tract infections.
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