Novartis has reported that the Phase III Lp(a)HORIZON trial of pelacarsen failed to meet its primary endpoint in patients with elevated Lp(a) and established cardiovascular disease (CVD).
The study did not show a reduction in the risk of cardiovascular events compared with placebo.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The primary endpoint was a composite measure covering cardiovascular death, non-fatal myocardial infarction, stroke and urgent coronary revascularisation requiring hospitalisation.
Patients taking pelacarsen achieved lower Lp(a) levels. All trial participants were already receiving guideline-directed care, including lipid-lowering and antihypertensive medicines.
Novartis development president and chief medical officer Shreeram Aradhye said: “Lp(a)HORIZON was a pioneering cardiovascular outcomes trial designed to answer one of the most important unanswered questions in cardiovascular medicine by evaluating whether lowering Lp(a) can reduce residual cardiovascular risk beyond optimised, guideline-directed care, when other major cardiovascular risk factors are already being managed.
“Although lower Lp(a) levels were observed with pelacarsen, the findings did not demonstrate that this translated into reduced cardiovascular risk in the overall study population.
“These are not the results we hoped for, but they provide important evidence that advances scientific understanding of the relationship between Lp(a) lowering and cardiovascular outcomes and may help inform future approaches to cardiovascular risk management.”
The double-blind, randomised, multi-centre, placebo-controlled trial enrolled 8,323 patients.
It assessed four-point major adverse cardiovascular events in an overall population with Lp(a) of 70mg/dL or above, and in a subpopulation with levels of 90mg/dL or above.
Pelacarsen is an antisense oligonucleotide designed to inhibit Lp(a) production. Novartis holds global development, manufacturing and commercialisation rights under a licence and collaboration agreement with Ionis Pharmaceuticals.
Prior to this, Novartis reported that its oral Bruton’s tyrosinekinase (BTK) inhibitor, remibrutinib, met its primary endpoint in two Phase III trials, REMODEL-1 and REMODEL-2, for adults with relapsing multiple sclerosis.
