PARIS (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNYNF, SNY) reported new positive results from six Phase 3 ODYSSEY trials, showing that alirocumab significantly reduced low-density lipoprotein cholesterol or LDL-C, or 'bad' cholesterol.
Alirocumab is an investigational fully human monoclonal antibody targeting the protein PCSK9, that is being evaluated for its ability to lower LDL-C.
All six trials, ODYSSEY LONG TERM, COMBO I, ALTERNATIVE, OPTIONS I, OPTIONS II, and HIGH FH, achieved their primary efficacy endpoint of a greater reduction in LDL-C at 24 weeks, versus either active comparator or placebo, which included standard-of-care therapy. Detailed results from these trials were presented during a special session on the ODYSSEY program today, and on November 17 during a late-breaker presentation at the American Heart Association (AHA) Scientific Sessions in Chicago, IL. In July, the companies had announced that all six studies met their primary efficacy endpoints.
Jennifer Robinson, M.D., M.P.H., Director of the Prevention Intervention Center, Professor, Departments of Epidemiology & Medicine, College of Public Health at the University of Iowa, said: 'New interim results from ODYSSEY LONG TERM provide further support for alirocumab's consistent safety profile, including in more than 500 patients who achieved LDL-C levels lower than 25 mg/dL.'
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