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The Medicines Co. announces ORION-11 study meets primary, secondary endpoints.

The Medicines Co. announced topline results from the first pivotal Phase 3 clinical trial evaluating the efficacy, safety and tolerability of inclisiran to decrease LDL-cholesterol, or LDL-C, through twice-yearly dosing. The ORION-11 study of inclisiran sodium 300 mg met all primary and secondary endpoints with efficacy consistent with findings from Phase 1 and 2 studies. The trial showed that inclisiran was well tolerated and confirmed that the safety profile was at least as favorable as that demonstrated in the ORION-1 Phase 2 and ORION-3 open label extension studies. Detailed efficacy, tolerability and safety data from ORION-11 will be presented during a late-breaking science session at the European Society of Cardiology's ESC Congress. ORION-11 is a pivotal Phase 3, placebo-controlled, double-blind, randomized study to evaluate the efficacy, safety and tolerability of inclisiran sodium 300 mg administered subcutaneously in 1,617 patients with atherosclerotic cardiovascular disease, or ASCVD, or ASCVD-risk equivalents and elevated LDL-C despite maximum tolerated dose of statin therapy. The international study was conducted at 70 sites in seven countries. 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 primary endpoints are percentage change in LDL-C from baseline to day 510 and time-adjusted percentage change in LDL-C from baseline after day 90 and up to day 540. Key secondary endpoints include the mean absolute change at Day 510, the average absolute reduction from Day 90 up to Day 540 and changes in other lipids and lipoproteins. The sequential release of topline Phase 3 data readouts for the ORION-9 and ORION-10 studies are expected to continue later in Q3 in advance of anticipated regulatory submissions in the U.S. in the Q4 and in Europe in Q1 of 2020. 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, safety and tolerability of long-term dosing of inclisiran.

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Publication:The Fly
Date:Aug 26, 2019
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