Novartis pelacarsen trial fails to meet primary endpoint

Novartis (NYSE: NVS) announced that its phase III Lp(a)HORIZON cardiovascular outcomes trial for pelacarsen did not meet its primary endpoint of reducing the risk of major cardiovascular events compared to placebo.

The trial's primary endpoint measured a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and urgent coronary revascularization requiring hospitalization. The study enrolled more than 8,000 participants who were receiving guideline-directed treatments, including lipid-lowering and antihypertensive therapies.

While pelacarsen did achieve lower lipoprotein(a), or Lp(a), levels in the study population, Novartis said this reduction did not translate into reduced cardiovascular risk in the overall study population.

"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," said Shreeram Aradhye, President of Development and Chief Medical Officer at Novartis.

Elevated Lp(a) is an inherited cardiovascular risk factor that affects approximately one in five people worldwide, according to the company's statement. No approved targeted treatment currently exists for the condition.

Novartis said the trial data will be presented at an upcoming medical congress.

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