The Medicines Company Announces Positive Topline Results from First Pivotal Phase 3 Trial of Inclisiran

The Medicines Company (NASDAQ: MDCO) today announced positive topline results from the first pivotal Phase 3 clinical trial evaluating the efficacy, safety, and tolerability of inclisiran to decrease LDL-cholesterol (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 2019, Paris, on Monday, September 2 at 8:30 am CET / 2:30 am EDT.

“This is a momentous occasion that further reinforces our confidence in the tremendous potential of inclisiran to fundamentally change the treatment of cardiovascular disease,” said Mark Timney, Chief Executive Officer of The Medicines Company. “I am proud of our clinical development team’s commitment to expeditiously advance this first-in-class investigational therapy that could help millions of ASCVD patients achieve treatment goals and live longer, healthier lives.”

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 (ASCVD) or ASCVD-risk equivalents and elevated LDL-C despite maximum tolerated dose of statin therapy (with or without ezetimibe). The international study was conducted at 70 sites in seven countries (ex-US). 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 (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.