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Pelacarsen lowered Lp(a) levels in more than 8,000 patients but did not reduce the risk of heart attacks, strokes, or cardiovascular death
Novartis announced last Thursday that pelacarsen, its experimental heart drug developed with Ionis Pharmaceuticals, failed to reduce cardiovascular risk in a large late-stage clinical trial, raising questions about a class of medicines that Amgen $AMGN and Eli Lilly $LLY are also pursuing.
The Phase III Lp(a)HORIZON trial enrolled 8,323 patients with elevated levels of lipoprotein(a), or Lp(a), and established cardiovascular disease. Although pelacarsen reduced Lp(a) levels in participants who were also receiving standard care, it did not meet its primary endpoint — a composite of cardiovascular death, non-fatal heart attack, non-fatal stroke, and urgent coronary revascularization requiring hospitalization — compared to placebo, the company said.
"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, in a statement. Full trial data will be presented at an upcoming medical congress.
