New analysis confirms LDL-C lowering effect of investigational inclisiran: ESC update
EAST HANOVER, N.J. - A post-hoc analysis of pooled data from the Phase III ORION-10 and -11 trials evaluatedthe individual responses of patients on low-density lipoprotein cholesterol (LDL-C) reduction with inclisiran. The analysis showed a highly consistent effect, with a safety and tolerability profile similar to placebo, on a twice-yearly dosing schedule after an initial dose and one 3 months later, across individual patients with atherosclerotic cardiovascular disease (ASCVD) or risk equivalents over 17 months of treatment.
Inclisiran is a first-in-class investigational treatment for hyperlipidemia in adults.
Presented at the ESC Congress 2020, the annual meeting of the European Society of Cardiology, the analysis evaluated the efficacy and tolerability of inclisiran on top of a maximally tolerated dose of statins, in two studies of more than 2,300 patients (of which 1,164 were on inclisiran) from the Phase III trials. Results demonstrated a low inter-individual variability, with 99% of inclisiran-treated patients showing a placebo-adjusted ≥30% reduction of their LDL-C levels with a mean reduction of 54.1% from baseline (observed values)2 .
"This analysis confirms that as a small interfering RNA (siRNA), inclisiran provides a remarkably consistent treatment profile. Nearly all patients from these trials achieved clinically meaningful reductions of their LDL-C levels over the 17 month period, and inclisiran had a safety and tolerability profile similar to placebo," said ORION-11 principal investigator Kausik Ray, M.D., Professor of Public Health, Consultant Cardiologist, Imperial College London. "These efficacy and safety results showcase the promise of inclisiran as a therapy for those ASCVD patients who cannot reach their LDL-C goals."
An LDL-C reduction of at least 50% was reached by 88.4% of patients at any time point in the study (observed values). After 17 months, 66.4% of the inclisiran group had a reduction in LDL-C of at least 50% as compared to 2.5% from the placebo group (observed values) 2. Overall, inclisiran was well-tolerated with a safety profile similar to placebo. All patients were on twice-yearly dosing, following an initial dose and one 3 months later.
"There remains an urgent need for innovative LDL-C-lowering therapies for patients not reaching their LDL-C target goals with current standard of care. This analysis reinforced our view of inclisiran's therapeutic value and its potential as the first cholesterol-lowering siRNA," said David Soergel, M.D., Global Head of Cardiovascular, Renal and Metabolic Drug Development, Novartis. "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 currently under review by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of primary hyperlipidemia (including Heterozygous Familial Hypercholesterolemia) in adults who have elevated LDL-C while being on a maximally tolerated dose of statin therapy.
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