Positive inclisiran results in persistent lowering of LDL cholesterol

The Medicines Company (Nasdaq: MDCO) on Saturday announced interim results from the ongoing ORION-3 open-label extension study (Group 1, n=290) which showed that twice-a-year dosing with inclisiran sodium 300mg resulted in consistent lowering of low density lipoprotein cholesterol (LDL-C) by more than 50% with overall follow-up of up to three years.

Inclisiran, the company’s lead developmental compound, was well tolerated, and no material safety issues were observed in the study. These results were presented during a late-breaking clinical trial session at the National Lipid Association (NLA) Scientific Sessions in Miami.

Inclisiran, the first cholesterol-lowering therapy in the siRNA class, is in Phase III clinical development to evaluate its ability to lower LDL-C through twice-a-year dosing. Pivotal Phase III readouts for inclisiran are expected in the third quarter. ORION-3 (n=382) is an open-label extension study of the Phase II ORION-1 trial to assess the efficacy, safety and tolerability of long-term dosing of inclisiran.