Novartis' Phase III V-MONO Trial Demonstrates Efficacy of Leqvio in Reducing LDL-C in ASCVD Patients
Novartis has announced that its Phase III V-MONO clinical trial evaluating the small interfering RNA (siRNA) therapy Leqvio (inclisiran) in patients with low or moderate risk of atherosclerotic cardiovascular disease (ASCVD) met its primary endpoints. The trial results demonstrated that Leqvio, used as a monotherapy, achieved a clinically meaningful and statistically significant reduction in low-density lipoprotein cholesterol (LDL-C) levels compared to ezetimibe and a placebo.
The six-month, randomized, double-blind, placebo- and active-comparator controlled study enrolled 350 patients and assessed the efficacy of Leqvio as a single agent against ezetimibe and a placebo. Patients were assigned in a 2:1:1 ratio to receive Leqvio, ezetimibe, or a placebo, with the primary endpoint being the percent change in LDL-C from baseline to day 150.
The V-MONO trial is reportedly the first to evaluate an siRNA therapy as a monotherapy specifically for lowering LDL-C in patients at low or moderate risk of developing ASCVD. Based on these findings, Novartis plans to engage with regulatory authorities, including the U.S. Food and Drug Administration (FDA), to discuss potential next steps.
Leqvio is administered subcutaneously by a healthcare provider, with an initial dose followed by a second dose after three months, and subsequent doses every six months. Novartis obtained global rights to Leqvio through a licensing and collaboration agreement with Alnylam Pharmaceuticals.
Shreeram Aradhye, President of Development and Chief Medical Officer at Novartis, commented on the significance of the trial results:
“We are proud to continue advancing 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.”
In addition to this recent trial, Novartis is conducting multiple studies to explore the use of Leqvio in both primary and secondary prevention of cardiovascular events. Earlier this year, the company also reported data from two Phase III trials highlighting the sustained efficacy and long-term safety of remibrutinib, an oral Bruton’s tyrosine kinase inhibitor, in the treatment of chronic spontaneous urticaria (CSU).
Topics: Clinical Trials
