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Novartis announced today that its Phase 3 V-MONO clinical trial has achieved its primary endpoint. The twice-yearly small interfering RNA (siRNA) therapy, Leqvio (inclisiran), as a monotherapy, significantly reduced low-density lipoprotein cholesterol (LDL-C) levels in patients with moderate to low-risk atherosclerotic cardiovascular disease (ASCVD) who had not previously received lipid-lowering treatment. This positive data supports the submission of an expanded indication for Leqvio as a cardiovascular disease prevention therapy. Novartis will submit the trial results to regulatory authorities, including the U.S. FDA, and will present detailed data at upcoming medical conferences. According to the press release, V-MONO is the first trial to evaluate siRNA therapy as a monotherapy for reducing LDL-C levels in moderate to low-risk ASCVD patients.
Atherosclerosis is a medical condition where plaque, a sticky substance made of cholesterol, fat, blood cells, and other elements, builds up inside your arteries. This leads to a narrowing of the arteries, reducing blood flow and oxygen supply to vital organs, and is a significant cause of heart disease. Atherosclerosis-related diseases are the leading cause of death in the United States. Atherosclerosis progresses slowly as the plaque accumulates within the artery walls. Over time, the buildup causes the arteries to harden and narrow, limiting blood flow. This reduced blood flow can deprive the body's tissues and organs of oxygen, leading to severe complications.
The V-MONO trial is a 6-month, randomized, double-blind Phase III study with a placebo and active comparator (ezetimibe) designed to assess the efficacy and safety of Leqvio as a monotherapy in moderate to low-risk ASCVD patients who have not received lipid-lowering treatment. A total of 350 patients were randomly assigned in a 2:1:1 ratio to receive Leqvio (n=174), the active comparator (n=89), or placebo (n=87). The primary endpoint was the percentage change in LDL-C levels from baseline to day 150 for Leqvio compared to placebo and the active comparator.
Leqvio is a "first-in-class" RNA interference (RNAi) therapy targeting the mRNA of the PCSK9 protein, initially approved by the U.S. FDA in December 2021 as an adjunct to diet and statin therapy for treating adult patients with primary hyperlipidemia, including those with heterozygous familial hypercholesterolemia (HeFH), to lower their LDL-C levels. Leqvio binds to the mRNA that encodes the PCSK9 protein and reduces its levels through RNA interference, preventing the liver from producing PCSK9 protein. The role of PCSK9 is to inhibit the recycling and reutilization of low-density lipoprotein (LDL) receptors. Therefore, lowering the levels of PCSK9 allows more LDL receptors to return to the surface of liver cells, where they can bind to and remove more LDL from the bloodstream. According to the press release, it is the first siRNA therapy that can effectively lower LDL-C.
The FDA's approval of Leqvio was based on the results of three Phase III clinical trials: ORION-9, ORION-10, and ORION-11, which enrolled 3,457 participants with atherosclerotic cardiovascular disease or HeFH, whose LDL-C levels remained elevated despite receiving the maximum tolerated dose of statins. At 17 months into the trials, Leqvio effectively and persistently reduced LDL-C levels by up to 52% compared to placebo, with good tolerability. These clinical results were also published in the New England Journal of Medicine. Long-term data from the ORION-8 Phase III trial, published last August, showed that administering Leqvio biannually in addition to statin therapy led to sustained reductions in LDL-C for over six years in patients at increased risk for ASCVD or HeFH.
Leqvio must be administered via subcutaneous injection by a healthcare professional, with an initial dose followed by a second dose three months later, and then a dose every six months. The biannual dosing schedule of Leqvio may help improve patient adherence to treatment, a common issue in cholesterol management. Leqvio has currently been approved in nearly 100 countries and regions, including the United States, European Union, Japan, and China. Originally developed by Alnylam Pharmaceuticals, Novartis later acquired the global rights for the development, manufacturing, and commercialization of Leqvio.
BOC Sciences offers comprehensive RNA interference (RNAi) services dedicated to providing high-quality solutions for research and drug development. Our services include the design and synthesis of small interfering RNAs (siRNA), functional validation of miRNAs, and support for RNAi-related experiments. With advanced technology platforms and extensive experience, we can meet diverse customer needs in gene expression regulation and disease model research. We look forward to collaborating with partners to advance research and applications in the RNAi field and achieve greater scientific breakthroughs!
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