Positive results for inclisiran in ORION-10 study to treat atherosclerotic cardiovascular disease.-The Medicines Company

The Medicines Company announced positive topline results for the ORION-10 Phase III clinical study in patients with atherosclerotic cardiovascular disease (ASCVD), successfully completing the pivotal Phase III LDL-cholesterol (LDL-C) lowering clinical trials for inclisiran. ORION-10 met all primary and secondary endpoints, and inclisiran demonstrated efficacy, tolerability and safety that were at least as favorable as observed in ORION-11, with no treatment-related liver or renal laboratory abnormalities.

Detailed efficacy, tolerability and safety data from ORION-10 will be presented at the American Heart Association (AHA) Scientific Sessions in Philadelphia on Saturday, November 16, 11:06 am EST, during Late Breaking Science I: Outside the Box: New Approaches to CVD Risk Reduction. The company will also present data from the ORION-9 study in patients with Heterozygous Familial Hypercholesterolemia (HeFH) at the AHA congress on Monday, November 18, 9:24am EST, during Late Breaking Science VI: New Frontiers in Lipid Therapy.

The ORION program is studying the efficacy and safety of inclisiran in patients with ASCVD and FH, with ORION-9, ORION-10 and ORION-11 comprising the pivotal Phase III LDL-C lowering studies.

Comment; Inclisiran lowers low-density lipoprotein (LDL),( bad cholesterol), using a pathway similar to Repatha (evolocumab) and Praluent (alirocumab). Inclisiran differs as it blocks genetic expression of a protein called PCSK9, while Repatha and Praluent block it after it has already been produced in the body. Inclisiran is injected once every six months, while Repatha and Praluent must be dosed at least once a month.