Inclisiran was obtained by Novartis with the acquisition of The Medicines Company. Credit: Novartis AG.

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.

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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.

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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.