Novartis has revealed that its Phase III V-MONO clinical trial of a small interfering RNA (siRNA) therapy, Leqvio (inclisiran), in people at low or moderate risk of atherosclerotic cardiovascular disease (ASCVD) met the primary endpoints.
The six-month, randomised, double-blind, placebo- and active-comparator controlled V-MONO trial involved 350 patients.
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It compared the efficacy of Leqvio as a single agent against ezetimibe and a placebo.
Patients were randomised into a 2:1:1 ratio to receive either Leqvio, ezetimibe, or a placebo.
The percent change in LDL-C from baseline to day 150 for Leqvio treatment versus the placebo and ezetimibe was the trial’s primary endpoints.
Trial findings showed that Leqvio monotherapy led to clinically meaningful and statistically significant low-density lipoprotein cholesterol (LDL-C) reduction compared to the other treatments.
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By GlobalDataThis study is claimed to be the first to evaluate an siRNA therapy used as a monotherapy to lower LDL-C in people at low or moderate risk of developing ASCVD.
Novartis plans to discuss these findings with regulatory authorities, including the US Food and Drug Administration (FDA).
The company is actively conducting multiple studies to explore the use of Leqvio in both primary and secondary prevention of cardiovascular events.
Leqvio is administered subcutaneously by a healthcare provider, initially, with another dose at three months, followed by a dose every six months.
Novartis secured worldwide rights to Leqvio under a licensing and collaboration agreement with Alnylam Pharmaceuticals.
Novartis Development president and chief medical officer 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.”
In May this year, the company released data from two Phase III trials confirming the sustained efficacy and long-term safety of remibrutinib, an oral Bruton’s tyrosine kinase inhibitor, in treating chronic spontaneous urticaria (CSU).
