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news.Sanofi and Regeneron Pharmaceuticals have announced the data from two Phase II trials with SAR236553/REGN727, an investigational subcutaneously administered, fully-human antibody targeting PCSK9.
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Study 11565 administered 183 patients with one of five different dose regimens of SAR236553/REGN727, either 50mg, 100mg, or 150mg Q2W, or 200mg or 300mg Q4W alternating with placebo at two weeks, plus continued atorvastatin or placebo.
In the study 11566, 92 patients were randomised to either titration from atorvastatin 10mg to atorvastatin 80mg plus SAR236553/REGN727 150mg Q2W, titration from atorvastatin 10mg to atorvastatin 80mg plus placebo, or continued atorvastatin 10mg plus SAR236553/REGN727 150mg Q2W.
The primary endpoint of study 11565 was the change in LDL-cholesterol from baseline over the 12-week study period
The primary end point of study 11566 it was the change in LDL-cholesterol from baseline over the eight-week study period.
Both trials showed that treatment with SAR236553/REGN727 over eight to 12 weeks considerably reduced mean low-density lipoprotein-cholesterol by 40% to 72% in patients with elevated LDL-C on a stable dose of statins.
Sanofi global research and development president Elias Zerhouni said genetic data has shown that patients with natural loss-of-function mutations in PCSK9 have lower LDL-C and a lower risk of coronary heart disease.