On November 7, Swiss pharmaceutical giant Novartis AG announced it is largely abandoning development of its experimental cardiovascular drug pelacarsen, after a seven-year Phase III clinical trial involving 8,322 patients showed that although the drug reduced blood levels of lipoprotein(a), or Lp(a), by an average of 78%, it failed to effectively reduce heart attacks, strokes, or cardiovascular deaths.
The drug had previously been highly anticipated, with the market once expecting its annual sales to potentially reach billions of dollars. The trial, named Lp(a) HORIZON, was the world's first completed Phase III cardiovascular outcomes study targeting lipoprotein(a).
Lipoprotein(a) is a type of lipoprotein primarily influenced by genetic factors and is associated with an elevated risk of atherosclerosis and thrombosis. Approximately 20% of the global population has genetically inherited high Lp(a) levels. The medical community had widely hoped that significantly lowering this marker could open up new avenues for cardiovascular disease prevention.
However, the trial results showed that although pelacarsen significantly reduced Lp(a) levels, it demonstrated no clear cardiovascular clinical benefit across all patient subgroups. Steven Nissen, a cardiovascular specialist at the Cleveland Clinic and senior author of the study, said: "The results of this trial are completely neutral. It did no harm, it did no good — it is a thoroughly neutral result."
Novartis AG stated that it will halt development of pelacarsen for atherosclerotic cardiovascular disease, retaining only one interim clinical study to continue evaluating whether the drug can slow the progression of calcific aortic valve stenosis. The failure of this trial also poses new challenges to the therapeutic strategy of preventing cardiovascular events by lowering Lp(a) levels.
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