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.
For more information visit themedicinescompany.com.
This article originally appeared on MPR