The Medicines Company has announced that inclisiran met all primary and secondary efficacy endpoints in the Phase III ORION-11 clinical trial for lowering LDL-cholesterol (LDL-C).
Inclisiran is a small-interfering RNA (siRNA) therapy that uses the body’s RNA interference process to selectively block the production of the PCSK9 protein in the liver.
This mechanism boosts the liver’s ability to eliminate LDL-C from the bloodstream and lowers cholesterol levels.
The placebo-controlled, double-blind, randomised ORION-11 study investigated the safety, efficacy and tolerability of subcutaneous inclisiran in 1,617 patients at 70 sites across seven countries.
Participants had atherosclerotic cardiovascular disease (ASCVD) or its risk equivalents and high LDL-C even after receiving the maximum tolerated dose of statin therapy.
Inclisiran sodium 300mg was given initially, then at three months and every six months thereafter.
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The trial’s primary endpoints are the percentage change from baseline in LDL-C to day 510 and time-adjusted percentage change after day 90 and up to day 540.
Key secondary endpoints of the study include the mean absolute change at day 510, the average absolute decrease from day 90 and up to day 540, as well as changes in additional lipids and lipoproteins.
Top-line results showed that the efficacy of twice-yearly 300mg inclisiran sodium was consistent with Phase I and II data.
In addition, the drug was well tolerated and its safety profile was claimed to be ‘at least as favourable’ as the previous open-label extension studies.
The Medicines Company CEO Mark Timney said: “This is a momentous occasion that further reinforces our confidence in the tremendous potential of inclisiran to fundamentally change the treatment of cardiovascular disease.
“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.”
Top-line data from the Phase III ORION-9 and ORION-10 trials are expected to be available over the coming months. The company intends to file for regulatory approval in the US by the end of this year and in Europe in the first quarter of next year.
The Medicines Company licenced the drug from Alnylam Pharmaceuticals.
The company is currently assessing the long-term efficacy, safety and tolerability of inclisiran in an open-label extension study.