Novartis’ pelacarsen fails Phase III trial in 8,323 patients

  • Novartis said pelacarsen failed to reduce cardiovascular risk in the Phase III Lp(a)HORIZON trial.
  • 8,323 patients with elevated Lp(a) and established cardiovascular disease participated in the study.
  • Novartis said full trial data will be presented at an upcoming medical congress.

Novartis said pelacarsen, an experimental heart drug developed with Ionis Pharmaceuticals, failed to reduce cardiovascular risk in the Phase III Lp(a)HORIZON trial, despite lowering Lp(a) levels among patients receiving standard care. The study enrolled 8,323 people with elevated Lp(a) and established cardiovascular disease, but pelacarsen did not outperform placebo on a composite endpoint covering cardiovascular death, non-fatal heart attack, non-fatal stroke and urgent coronary revascularization requiring hospitalization. Lp(a) is an inherited cardiovascular risk factor affecting roughly one in five people worldwide, and no approved targeted treatment exists. The result is the first significant late-stage setback among the current group of Lp(a)-lowering programs, according to CNBC, and weakened but did not disprove the hypothesis that reducing Lp(a) can lower cardiovascular risk. Novartis faces additional pressure after the recent failure of del-desiran and upcoming patent expirations for key products. Full trial data will be presented at an upcoming medical congress, while Novartis said the findings may inform future approaches to cardiovascular risk management.

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