The investigational treatment inclisiran (The Medicines Company) was associated with a sustained reduction in low density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents and elevated LDL-C despite maximum tolerated doses of LDL-C lowering therapies.
Inclisiran is a chemically synthesized small interfering RNA (siRNA) that targets proprotein convertase subtilisin-kexin type 9 (PCSK9) messenger RNA. The injectable is being investigated for its ability to lower LDL-C through twice-a-year dosing. The latest findings come from the interim analysis of the ORION-3, phase 3 trial, an extension study of ORION-1.
In this study, a total of 290 patients (Group 1) previously treated with inclisiran in ORION-1, received twice-a-year injections of inclisiran 300mg, with a follow up at day 210 (the primary endpoint). Results showed a 51% (64.mg/dL, P <.001) reduction in LDL-C through day 210; the time-averaged absolute LDL-C reduction with inclisiran was 59.4mg/dL (P <.001). The overall safety profile of inclisiran during ORION-3 was comparable to that seen in ORION-1.
“These new data from ORION-3 provide further evidence of inclisiran’s unprecedented ability to deliver persistent LDL-C reductions over a prolonged period, which can help more patients reliably achieve LDL-C goals,” said John J.P. Kastelein, MD, PhD, and study chair of ORION-3.
Follow up data from Group 2 (n=92) of the ORION-3 study, in which patients who received placebo in ORION-1 are being treated for 1 year with evolocumab followed by 3 years of inclisiran, are expected in 2022.
The study will assess the safety and efficacy of switching from evolocumab to inclisiran.
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