Novartis has shared positive top-line results from a late-stage study evaluating Leqvio (inclisiran) as a monotherapy for patients who are at risk of developing atherosclerotic cardiovascular disease (ASCVD).
The phase 3 V-MONO trial has been comparing the small interfering RNA (siRNA) therapy to both placebo and ezetimibe in patients at a low or moderate risk of developing ASCVD and who are not receiving lipid-lowering therapy.
The study met its primary endpoints, with Leqvio monotherapy demonstrating superiority to both placebo and ezetimibe in low-density lipoprotein cholesterol (LDL-C) reduction.
Cardiovascular disease, including coronary heart disease and stroke, is the leading cause of death globally, according to the World Health Organization.
ASCVD accounts for 85% of all cardiovascular deaths and is caused by the development and growth of plaques in the inner lining of the arteries, which mainly comprise LDL-C that accumulates over time.
Already approved in almost 100 countries, Leqvio is designed to reduce levels of LDL-C in the blood. The therapy is administered as a subcutaneous injection by a healthcare provider (HCP) and is given as an initial dose, again at three months, and then every six months.
It is hoped that as a twice-yearly, HCP-administered treatment, Leqvio may help to improve treatment adherence, a common issue in cholesterol management.
Shreeram Aradhye, president, development and chief medical officer at Novartis, 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.”
Novartis has outlined its plans to present results from the trial at an upcoming medical meeting and share the data with regulatory agencies, including the US Food and Drug Administration.
The company obtained global rights to develop, manufacture and commercialise Leqvio under a licence and collaboration agreement with Alnylam Pharmaceuticals and said it continues to advance multiple studies evaluating the potential use of the therapy across primary and secondary prevention.