Clinical Development

ORION clinical development program

At The Medicines Company, we are devoted to the development of inclisiran – a small interfering RNA (siRNA) therapy being studied to evaluate its ability to lower low-density lipoprotein (LDL) cholesterol – also known as LDL-C or bad cholesterol. Inclisiran is designed to prevent the production of proprotein convertase subtilisin/kexin type 9 (PCSK9) at its primary source in the liver. Inclisiran is not yet approved for use by the FDA or any other regulatory authority.

The ORION program includes pivotal Phase 3 trials (ORION-9, ORION-10 and ORION-11), designed to evaluate the safety and efficacy of inclisiran in people with atherosclerotic cardiovascular disease (ASCVD) and elevated LDL-C despite the maximum tolerated dose of LDL-C-lowering therapies, as well as individuals with familial hypercholesterolemia (FH). We expect to release top-line data in the third quarter of 2019, to file a new drug application (NDA) with the FDA in the U.S. in the fourth quarter of 2019, and to file a marketing authorization application (MAA) in Europe in the first quarter of 2020. In these clinical trials, people receive inclisiran or placebo on Day 1 and Day 90, then an additional two doses six months apart.

In addition to these studies, the ORION-4 trial, which began enrolling in October 2018, is designed to evaluate cardiovascular outcomes in 15,000 people being treated with inclisiran or placebo.

ORION clinical trials

TrialStudy Purpose / PopulationClinical Phase
ORION-10Atherosclerotic cardiovascular disease (ASCVD) - U.S.3
ORION-11ASCVD and risk-equivalents - Europe3
ORION-9Heterozygous familial hypercholesterolemia (HeFH) - Global3
ORION-4Cardiovascular outcomes trial (CVOT) / ASCVD – United Kingdom and U.S.3
ORION-5Homozygous familial hypercholesterolemia (HoFH) - Global3
ORION-8Extension study of ORION-9, -10 and -11/ASCVD – Global3
ORION-3Long-term extension study of ORION-1 - Global2
Hepatic impairment - U.S.1
TQTc - U.S.1
ORION-11ASCVD - Global2 (Completed)
ORION-2Pilot study / Homozygous familial hypercholesterolemia (HoFH) - Global2 (Completed)
ORION-7Renal impairment - New Zealand1 (Completed)
1 Results from ORION-1 were presented at the American College of Cardiology’s 66th Annual Scientific Session and published in The New England Journal of Medicine.

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