US-based Medicines Company has completed enrolling patients in a Phase III trial of inclisiran for treatment of heterozygous familial hypercholesterolemia patients.
Enrolment of 400 patients in the ORION-9 trial has been completed ahead of schedule.
ORION-9 is a double-blind, randomised multi-national trial, which aims to confirm the effectiveness and safety of inclisiran in heterozygous familial hypercholesterolemia patients with elevated LDL-C levels above 100mg/dL despite maximum tolerated doses of LDL-C lowering therapies, including statins.
As part of the trial, patients are being randomised to receive inclisiran 300mg or placebo subcutaneously on days one, 90, 270, and 450, until the end of the study at 540 days.
Primary endpoint of the trial is LDL-C reduction from baseline to day 510.
Safety and tolerability of inclisiran will also be studied in the ORION-9 study, which is one of four pivotal Phase III trials with similar designs to confirm the safety and effectiveness of inclisiran.
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Medicines Company chief medical officer David Kallend said: “We look forward to completing the follow-up of ORION-9 and the enrolment and follow-up of other pivotal trials, so that we can review the data in the second half of 2019 as part of the anticipated NDA and MAA submissions.
“We believe that the rapid pace of enrolment in ORION-11 and ORION-9, 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, and the apparent ease-of-use of the protocol and study medication.”
In addition, Medicines Company, along with Alnylam Pharmaceuticals, is set to advance the development of inclisiran under an agreement signed in 2013.