Positive results for Regeneron and Sanofi's SAR236553/REGN727

USA-based Regeneron (Nasdaq: REGN) and French drug major Sanofi (Euronext: SAN) presented results of their third and final Phase II study at the European Atherosclerosis Society (EAS) Congress in Milan, Italy, on May 26, adding to the recently presented results of the other two studies in patients with primary hypercholesterolemia, for their investigational cholesterol-lowering agent SAR236553/REGN727 which is part of a global development collaboration.

The EAS late-breaker presentation covered Study R727-CL1003, which assessed SAR236553/REGN727 in patients with heterozygous familial hypercholesterolemia (heFH) who remained uncontrolled despite being on stable daily statin therapy, with or without ezetimibe. A total of 76% of patients were receiving the maximum dose of their statin at baseline, with 71% also taking ezetimibe.

The trial demonstrated that after 12 weeks of treatment, patients who received one of four different dosing regimens of SAR236553/REGN727 achieved mean reductions in LDL-cholesterol (LDL-C) from baseline ranging from 28.9% to 67.9% compared to a mean reduction of 10.7% with placebo (p<0.05 for all dose groups). In addition, in the most efficacious dose tested (150 mg every two weeks), 93.8% of patients treated with SAR236553/REGN727 achieved LDL-C levels lower than 100 mg/dL (2.59 mmol/L), compared to 13.3% of patients in the placebo arm, and 81.3% reached LDL-C levels lower than 70mg/dL (1.81mmol/L), compared to none in the placebo arm. The most common adverse event was injection-site reaction, and there were no serious adverse events on active treatment.