The Medicines Company announced presentation of analyses of two clinical studies of inclisiran at the 87th European Atherosclerosis Society (EAS) Congress in Maastricht, Netherlands. A combined analysis (N=279) from the Phase 2 ORION-1 and Phase 1 ORION-7 trials, presented during an e-poster session, demonstrated that patients across a range of renal function levels achieved consistent reductions in low-density lipoprotein cholesterol (LDL-C) with no dose adjustment necessary for patients with renal impairment. Results from the Phase 2 ORION-2 pilot study, presented as a late-breaking abstract, showed that inclisiran provided durable reductions in LDL-C levels up to day 180 in patients with homozygous familial hypercholesterolemia (HoFH), a genetic disorder characterized by very high levels of LDL-C and early onset of cardiovascular disease, without the need to increase the dose of inclisiran. Inclisiran, the first cholesterol-lowering therapy in the siRNA class, is The Medicines Company’s investigational therapy in Phase 3 clinical development to evaluate its ability to lower LDL-C through twice-a-year dosing. The company expects pivotal Phase 3 data readouts for inclisiran in the third quarter of 2019 followed by anticipated regulatory filings in the U.S. in the fourth quarter of 2019 and in Europe in the first quarter of 2020.