The Medicines Company has reported positive results from the Phase III ORION-10 clinical trial, where cholesterol-lowering drug inclisiran met all primary and secondary endpoints in atherosclerotic cardiovascular disease (ASCVD) patients.
Inclisiran is a small-interfering RNA (siRNA) therapy that uses the body’s RNA interference process to prevent the production of the PCSK9 protein in the liver.
The mechanism is said to improve the liver’s ability to remove and reduce the levels of low-density lipoprotein cholesterol (LDL-C) in the blood.
In the ORION-10 study, 300mg inclisiran sodium’s safety, efficacy and tolerability were evaluated in 1,561 ASCVD patients with increased LDL-C even after receiving a maximum tolerated dose of LDL-C-lowering drugs.
The trial was performed at 145 US sites and involved subcutaneous administration of the drug.
The primary endpoints were a percentage change in LDL-C to day 510 and time-adjusted percentage change in LDL-C after day 90 and up to day 540.
The trial’s key secondary endpoints also included the mean absolute change at day 510, the average absolute decrease from day 90 and up to day 540, and in other lipids and lipoprotein changes.
According to the top-line data, inclisiran showed a safety, efficacy and tolerability profile that was at least as favourable as that found in ORION-11, which is a separate Phase III trial of the drug candidate conducted in ASCVD patients.
In ORION-10, investigators did not report any treatment-related liver or renal laboratory abnormalities.
The Medicines Company CEO Mark Timney said: “The results seen in ORION-10 again demonstrate inclisiran’s outstanding efficacy, tolerability and safety.
“This is further validation of the potential of this first and only investigational cholesterol-lowering therapy in the siRNA class to transform the treatment of cardiovascular disease for millions of people with ASCVD.”
The company plans to submit applications seeking regulatory approval for inclisiran in the US and Europe in the fourth quarter of this year and the first quarter of next year, respectively.