The Medicines Co's ORION-10 study of Inclisiran met primary, secondary endpoints
The Medicines Company announced detailed results from ORION-10, the second of three pivotal 18-month low-density lipoprotein cholesterol, or LDL-C, lowering Phase 3 clinical studies of inclisiran, an investigational twice-yearly therapy to reduce LDL-C and the first and only cholesterol-lowering treatment in the siRNA class. In ORION-10, twice-yearly dosing with inclisiran sodium 300 mg met all primary and secondary efficacy endpoints, was well-tolerated and again demonstrated an excellent safety profile. Full study results were presented during a late-breaking science session at the American Heart Association, or AHA, Scientific Sessions in Philadelphia. "Cumulative exposure to high LDL-C levels presents a significant risk of future heart attacks and strokes for millions of people, particularly those with ASCVD," said study principal investigator R. Scott Wright, M.D., Professor of Medicine, Consultant in Cardiology, Mayo Clinic in Rochester, Minnesota. "The data from ORION-10 show that inclisiran lowers LDL-C significantly and sustains reductions over a six-month period with a safety profile similar to placebo."