The Medicines Company has completed enrolling patients following the randomisation of more than 1,500 patients in the Orion-10 trial in the US within 12 weeks, which is ten weeks ahead of schedule.
The ORION-10 trial is a double-blind, placebo-controlled, randomised study that aims to confirm the efficacy and safety of inclisiran in patients with atherosclerotic cardiovascular disease (ASCVD).
As part of the trial, patients have been randomised to inclisiran sodium 300mg or placebo provided subcutaneously on days one, 90, 270 and 450, and then followed to the end of the study at day 540.
Similar to two other trials ORION-9 and ORION-11, the ORION-10 study has enrolled ASCVD patients, who have elevated LDL-C levels above 70mg/dL despite maximum tolerated doses of LDL-C lowering therapies, including statins.
The primary endpoint of ORION-10 is LDL-C reduction from baseline to day 510. It will also examine the safety and tolerability of inclisiran.
The Medicines Company CEO Dr Clive Meanwell said: “Completion of enrolment in ORION-10 is one of the key milestones in our quest to confirm the promising safety and efficacy data for inclisiran, which were reported during Phase I and Phase II clinical studies.
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“We believe that the rapid pace of enrolment in the pivotal trials of the ORION programme, as well as the quality of data emerging from this and other trials, reflect the design of the studies, the effective operational support of excellent clinical sites, exceptional work by our team and our partners at PPD, and the apparent ease of use of the protocol and study medication.”
Inclisiran is an investigational GalNAc-conjugated RNA interference therapeutic and has the potential to reduce liver cell LDL-receptor turnover, and plasma LDL-C.