Ionis Pharmaceuticals announced that its partner, Novartis, reported that the Phase 3 Lp(a)HORIZON study for the drug pelacarsen did not meet its primary endpoint. The trial was designed to evaluate the reduction of cardiovascular event risk in patients with elevated lipoprotein (a) (Lp(a)). While the drug successfully lowered Lp(a) levels, this did not translate to a statistically significant reduction in major adverse cardiovascular events compared to placebo.
Key Details
- Primary Endpoint Failure: The study failed to reduce the risk of its composite primary endpoint, which included cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and urgent coronary revascularization.
- Drug Performance: Pelacarsen substantially lowered Lp(a) levels, consistent with previous studies, and demonstrated an acceptable safety profile, but this did not result in the desired clinical benefit.
- Partnership: Pelacarsen was discovered and initially developed by Ionis. Novartis licensed the rights to develop and commercialize the drug in February 2019.