The Medicines Company Announces that the ORION-10 Study of Inclisiran in ASCVD Patients Showed Durable and Potent Lowering of LDL-C with Twice-Yearly Dosing - Seite 2

ORION-10 data will be submitted to a peer-reviewed medical journal. The company expects to file regulatory submissions in the U.S. in the fourth quarter of 2019 and in Europe in the first quarter of 2020.

Data from ORION-9, a Phase 3 clinical study of inclisiran in patients with heterozygous familial hypercholesterolemia (HeFH), will be presented at AHA on Monday, November 18, 9:24am EST, during Late Breaking Science VI: New Frontiers in Lipid Therapy. The company previously announced (click here) topline results of ORION-9.

ORION-10 Study Design

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 3 LDL-C lowering studies.

ORION-10 is a pivotal Phase 3, placebo-controlled, double-blind, randomized study to evaluate the efficacy and safety of inclisiran sodium 300 mg administered subcutaneously in 1,561 participants with ASCVD and elevated LDL-C, despite maximum tolerated dose of LDL-C-lowering therapies (e.g., a statin or ezetimibe). The primary endpoints are percentage change in LDL-C from baseline to day 510 (17 months) and time-adjusted percentage change in LDL-C from baseline after day 90 (three months) and up to day 540 (18 months). Key secondary endpoints include the mean absolute change at Day 510 (17 months), the average absolute reduction from Day 90 (three months) up to Day 540 (18 months), and changes in other lipids and lipoproteins. The study was conducted at 145 sites in the United States. Each study participant received inclisiran sodium 300 mg administered as a subcutaneous injection initially, again at three months and then every six months thereafter. The majority of study participants were taking inclisiran or placebo in addition to existing lipid-lowering therapy with a maximally tolerated statin (with or without ezetimibe).

Patients who have completed their respective Phase 3 studies are now enrolling into ORION-8, an open-label, long-term extension study where patients completing ORION-9, ORION-10 and ORION-11 will receive inclisiran for three years to evaluate the efficacy and safety of long-term dosing of inclisiran.

ORION-9 and ORION-10 Investor Conference Call and Webcast Information

The Medicines Company will host a conference call and webcast for investors on Monday, November 18, 2019 at 12:00 pm EST. During the call, the Company’s management and ORION program clinical investigators will discuss results of the ORION-9 and ORION-10 Phase 3 clinical studies. The dial-in information to access the call is as follows: