Results of the phase 3 trial show that inclisiran reduced LDL cholesterol in patients with atherosclerotic cardiovascular disease.
The Medicines Company has announced the ORION-11 study, which examined the use of inclisiran to decrease LDL-cholesterol, met primary and secondary efficacy endpoints.
Revealed at the European Society of Cardiology’s ESC Congress 2019 in Paris, results of the international phase 3 trial showed inclisiran sodium 300 mg administered subcutaneously dosed twice-yearly reduced LDL-C from baseline.
“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 fficer 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 was a phase 3, placebo-controlled, double-blind, randomized trial designed to evaluate the safety, efficacy and tolerability in patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents and LDL-C despite maximum tolerated doses of statin therapy. A total of 1617 patients from 70 sites in 7 different countries were included in the study.
Patients in the study received inclisiran as an injection, then again at 3 months and, following that, every 6 months. The primary endpoint of the study was LDL-C change from baseline to day 510 and time-adjusted percentage change in LDL-C from baseline after 3 months and up to day 540 of the study. Secondary endpoints included mean absolute change in LDL-C at day 510, the average absolute reduction from day 90 up to day 540, and changes in other lipids and lipoproteins.
In addition to meeting primary and secondary efficacy endpoints, a press release from The Medicines Company noted inclisiran was well-tolerated and confirmed the safety profile was at least favorable — as demonstrated in the ORION-1 and ORION-3 open-label extension studies. Additionally, phase 3 data readouts for the ORION-9 and ORION-10 studies are expected in the third quarter in a dance of regulatory submissions in the US in the fourth quarter of 2019.
“The Medicines Company thanks the many patients, investigators and their colleagues at the clinical trial sites for their participation in ORION-11,” said Peter Wijngaard, PhD, Chief Development Officer of The Medicines Company. “We look forward to presenting detailed study results during the ESC Congress 2019 and also submitting data for publication in a peer-reviewed journal.”
Results of the ORION-11 study were presented on Monday, September 2, 2019 at the European Society of Cardiology’s ESC Congress 2019 in Paris.