Novartis has updated the timeline for its Phase 3 cardiovascular outcomes trial of pelacarsen, with data now expected in the first half of 2026. The announcement came as part of the company's year-end earnings report, pushing regulatory submissions to the second half of that year.
The timeline adjustment reflects the current accrual rate of blinded events in the ongoing Lp(a)HORIZON study, a landmark cardiovascular outcomes trial involving more than 8,000 patients. Despite the extended timeline, Ionis Pharmaceuticals, which discovered and initially developed pelacarsen, maintains strong confidence in both the drug candidate and the trial's potential to demonstrate cardiovascular benefits.
Groundbreaking Study Design and Market Potential
The Lp(a)HORIZON trial holds particular significance as it is positioned to become the first cardiovascular outcomes trial to report results on how Lp(a) reduction affects cardiovascular risk. This pioneering position could establish pelacarsen as a first-in-class therapy for this specific cardiovascular risk factor.
Pelacarsen, an investigational antisense medicine, was specifically designed to lower lipoprotein(a) levels, addressing a critical unmet need in cardiovascular medicine. The drug's potential market is substantial, with more than eight million people worldwide estimated to have both elevated Lp(a) levels and cardiovascular disease.
Strategic Partnership and Development History
The development of pelacarsen represents a successful collaboration between biotech innovation and pharmaceutical scale. Following its discovery at Ionis Pharmaceuticals, the drug candidate was licensed to Novartis in 2019, combining Ionis's expertise in antisense technology with Novartis's global development and commercialization capabilities.
The partnership continues to advance pelacarsen through late-stage development, with both companies maintaining optimism about its potential to address a significant gap in cardiovascular treatment options. The focus remains on generating robust evidence through the Lp(a)HORIZON trial to demonstrate the clinical benefit of Lp(a) lowering in reducing cardiovascular risk.
