PARIS (dpa-AFX) - French drugmaker Sanofi (SNYNF, SNY) and New York based Regeneron Pharmaceuticals, Inc. (REGN) said Wednesday that the Phase 3 ODYSSEY MONO trial with alirocumab, an investigational monoclonal antibody targeting PCSK9, met its primary efficacy endpoint. The mean low-density lipoprotein-cholesterol reduction from baseline to week 24, the primary efficacy endpoint of the study, was significantly greater in patients randomized to alirocumab, as compared to patients randomized to ezetimibe. According to the study, Alirocumab monotherapy reduced 'bad' cholesterol three times more than ezetimibe.
'We are excited with the findings from the first Phase 3 trial with alirocumab. While the majority of our clinical program is investigating alirocumab in combination with lipid-lowering therapies, these monotherapy results are encouraging,' said Jay Edelberg M.D., Ph.D., Head of the PCSK9 Development and Launch Unit, Sanofi Group.
'We look forward to results from the remaining Phase 3 trials, which are investigating alirocumab in a variety of patient populations, combinations with different background therapies, and dosing regimens, ' he added.
The percentage of patients who reported treatment emergent adverse events was 78.4% in the ezetimibe group and 69.2% in the alirocumab group. The most common class of adverse events was infections, which included nasopharyngitis, influenza, and upper respiratory tract infection.
ODYSSEY MONO is the first study to report data from the 12 Phase 3 trials, been initiated so far as part of over 23,000 patient ODYSSEY clinical trial program
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