21 May 2019 - - US-based pharmaceutical company The Medicines Company (NASDAQ: MDCO) has released 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 300 mg resulted in consistent lowering of low density lipoprotein cholesterol (LDL-C) by more than 50% with overall follow-up of up to three years, the company said.

Inclisiran 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 Scientific Sessions in Miami.

Inclisiran, the first cholesterol-lowering therapy in the siRNA class, is in Phase 3 clinical development to evaluate its ability to lower LDL-C through twice-a-year dosing. Pivotal Phase 3 readouts for inclisiran are expected in 3Q19.

ORION-3 (n=382) is an open-label extension study of the Phase 2 ORION-1 trial to assess the efficacy, safety and tolerability of long-term dosing of inclisiran.

In this interim analysis of ORION-3, inclisiran demonstrated a 51% (64.0 mg/dL, p