Novartis reports that pelacarsen failed to reduce cardiovascular risk in late-stage heart disease trial
Novartis reported that the pelacarsen phase III Lp(a)HORIZON trial failed to meet its primary endpoint of reducing the risk of cardiovascular events. The study tested 8,323 people with established cardiovascular disease and elevated lipoprotein (a), a genetically driven blood fat that affects approximately one in five people worldwide. While pelacarsen successfully lowered Lp(a) levels in the study population, it did not significantly reduce the combined risk of cardiovascular death, non-fatal heart attack, or non-fatal stroke compared to a placebo. Shreeram Aradhye, the chief medical officer of Novartis, stated that these were not the results the company hoped for, but the data still provide important evidence regarding the relationship between Lp(a) lowering and cardiovascular outcomes. The company obtained global rights to develop and commercialize pelacarsen under a license from Ionis Pharmaceuticals. The failure of the trial is a significant development for Novartis as it works to replace older blockbusters facing generic competition. Full results of the trial will be presented at an upcoming medical congress.