Novartis Heart Drug Pelacarsen Fails Major Trial, Casting Doubt on Lp(a) as a Treatment Target
Written by AI from finance.yahoo.com's report. Not checked by a person.
Novartis's experimental drug pelacarsen reduced Lp(a) levels in a Phase 3 trial of 8,323 patients but failed to lower the rate of heart attacks, strokes or cardiovascular deaths, raising questions about drugs in this class being developed by Amgen and Eli Lilly as well.
Novartis announced last Thursday that pelacarsen, its experimental cardiovascular drug co-developed with Ionis Pharmaceuticals, had failed the pivotal Lp(a)HORIZON Phase 3 clinical trial. The study enrolled 8,323 patients with elevated lipoprotein(a) — an inherited cardiovascular risk factor affecting roughly one in five people worldwide — who also had established cardiovascular disease. Although pelacarsen successfully reduced participants' Lp(a) levels on top of standard care, it did not meet the trial's primary endpoint: a composite of cardiovascular death, non-fatal heart attack, non-fatal stroke, and urgent coronary revascularization requiring hospitalization, compared with placebo. Full trial data will be presented at an upcoming medical congress. Citi analysts said additional data would be needed to determine whether the shortfall reflects pelacarsen's specific mechanism, the trial's design, or a broader challenge to the hypothesis that lowering Lp(a) reduces hard cardiovascular outcomes. The result also cast doubt over competing Lp(a)-targeting drugs being developed at Amgen and Eli Lilly, with Amgen shares falling roughly 5% in extended trading after the announcement, while Novartis stock dropped 3% on Monday. The failure marks the second major late-stage setback for Novartis in recent days, following the failure of del-desiran, an experimental treatment for myotonic dystrophy type 1, adding pressure on the Swiss drugmaker as it faces significant patent expirations in the coming years.
