Sanofi reports on Phase-II PCSK9 trial
Sanofi reported positive results from the Phase-II trial it conducted in Japan of PCSK9 inhibitor alirocumab. The trial was designed to demonstrate reduction of LDL or bad cholesterol from baseline to week 12. At week 12, average LDL reduction was 55% at 50mg, 62% at 75mg, and 72% at 150mg. The placebo group saw an average LDL reduction of 3%.
Regeneron's chief scientific officer, George Yancopoulous, commented, “Not only was alirocumab shown, in this study, to significantly reduce LDL-C in this patent population, the results of this study also demonstrate the potential efficacy of alirocumab at a range of doses.”
Dosing differences could play a bigger role if drugs like alirocumab reach market. With other mid-to-late-stage trials having demonstrated their ability to lower cholesterol, questions surrounding the emergent PCSK9 class are now commercial not clinical, analysts said recently.