Novartis has reported positive data from a post-hoc analysis of pooled data from the Phase III ORION-10 and -11 clinical trials of inclisiran in adults with hyperlipidemia.
Data revealed a safety and tolerability profile similar to placebo with twice-yearly dose of the drug in individual participants with atherosclerotic cardiovascular disease (ASCVD) or risk equivalents over 17 months of therapy.
The analysis reviewed the efficacy and tolerability of inclisiran on top of a maximally tolerated dose of statins, in a total of more than 2,300 patients across the Phase III studies.
Results showed a low inter-individual variability, said Novartis. Around 99% of participants on inclisiran had a placebo-adjusted ≥30% decrease of their low-density lipoprotein cholesterol (LDL-C) levels with a mean reduction of 54.1% from baseline.
At any time point in the trial, 88.4% of patients experienced an LDL-C reduction of at least 50%. Following 17 months of treatment, 66.4% in the inclisiran arm had a reduction of at least 50% versus 2.5% in the placebo group.
Overall, the drug was well-tolerated with a safety profile similar to placebo. All patients were given an initial dose and one three months later.
Novartis Cardiovascular, Renal and Metabolic Drug Development global head David Soergel said: “This analysis reinforced our view of inclisiran’s therapeutic value and its potential as the first cholesterol-lowering siRNA.
“With a unique twice-yearly dosing, if approved, inclisiran may fit seamlessly into patients’ regular healthcare visits and help us reimagine treatment for ASCVD.”
Inclisiran is an experimental cholesterol-lowering treatment obtained by Novartis with the acquisition of The Medicines Company.
Novartis has rights to develop, manufacture and commercialise the drug as part of a licence and collaboration deal with Alnylam Pharmaceuticals.
As a small-interfering RNA (siRNA), inclisiran is believed to work by leveraging the body’s natural process of removing LDL-C from the bloodstream.
ORION-10 and -11 assessed the efficacy, safety and tolerability of inclisiran sodium 300mg given subcutaneously.
In April this year, Novartis announced a Phase III trial to assess canakinumab (Ilaris) for the treatment of patients with Covid-19 pneumonia.