Novartis said that its Phase 3 V-MONO study has yielded positive topline results for Leqvio (inclisiran), a twice-yearly treatment for atherosclerotic cardiovascular disease (ASCVD).
Leqvio is said to be the first and only small interfering RNA (siRNA) therapy to lower low-density lipoprotein cholesterol (LDL-C).
It was first approved by the US Food and Drug Administration (FDA) in December 2021 to reduce LDL-C with just two doses per year, following the initial dose and an additional dose at three months.
V-MONO trial is the first to assess siRNA therapy as a monotherapy for lowering LDL-C in this patient population.
The six-month, randomised, double-blind, placebo- and active-comparator controlled that enrolled 350 patients.
The study met its primary endpoints, demonstrating that Leqvio monotherapy significantly reduced LDL-C compared to both placebo and ezetimibe.
This was observed in patients at low or moderate risk of developing ASCVD who were not on any lipid-lowering therapy.
Novartis plans to present the trial results at an upcoming medical meeting and will also share the findings with regulatory agencies, including the US Food and Drug Administration (FDA).
Novartis chief medical officer and development president Shreeram Aradhye said: “We are proud that we continue to advance the scientific understanding of using siRNA therapy to tackle one of the world’s biggest healthcare challenges, as too many people still struggle to reach their cholesterol goals.
“This trial adds to the growing body of evidence for Leqvio across the full spectrum of ASCVD as we strive to help more patients in need.”
The Swiss drugmaker is advancing several studies to explore the potential of Leqvio in both primary and secondary prevention.
The VICTORION-1-PREVENT (V1P) trial is the only study focused on a non-statin lipid-lowering therapy for high-risk primary prevention.
Enrolment for this outcomes study is expected to be completed later this year.
For secondary prevention, the ORION-4 and VICTORION-2-PREVENT (V2P) outcomes studies are progressing as planned, with results anticipated in 2026 and 2027, respectively.
The V-MONO study is part of an extensive clinical trial programme involving 60,000 patients, evaluating inclisiran for both primary and secondary prevention of ASCVD.
Leqvio is currently approved in nearly 100 countries, including the US, the European Union (EU), Japan, and China.
Novartis holds global rights to develop, manufacture, and commercialise Leqvio through a licensing and collaboration agreement with Alnylam Pharmaceuticals.
