Alirocumab (Sanofi) success in Phase III trial for Dyslipidaemia

Sanofi and Regeneron announced Phase III ODYSSEY MONO trial results with alirocumab,, an investigational monoclonal antibody, targeting PCSK 9 (proprotein convertase subtilisin kexin type 9)which met its primary efficacy endpoint.The mean low density lipoprotein cholesterol (LDL-C or "bad" cholesterol) reduction from baseline to week 24 was significantly greater in patients randomised to alirocumab compared to patients randomised to ezetimibe (47.2% vs. 15.6%).In the trial which employed a dose increase, up titration, for patients who did not achieve an LDL-C level of 70 milligram/declitre, the majority of patients remained on the initial dose of alirocumab of 75 milligrams(mg).

The percentage of patients who reported treatment emergent adverse events was 74.8% in the ezetimibe group and 69.2% in the alirocumab group.The most common class of adverse events was infections (39.3% with ezetimibe vs. 42.3% with alirocumab). ODYSSEY MONO was the first trial to report from the 12 Phase III trials of the ODYSSEY clinical trial program.