Pharmaceutical company Novartis has partnered with the U.K.’s National Health Service (NHS) to study inclisiran, an investigational cholesterol-lowering drug that experts project could save 30,000 lives over the next decade.
Inclisiran, a twice-yearly injection, is potentially the first and only cholesterol-lowering therapy in the small-interfering RNA (siRNA) drug class, according to the NHS. It’s currently in Phase III clinical development and is expected to be filed for approval later this year as a preventive add-on treatment to statins for patients already diagnosed with CVD.
The collaboration between the NHS and Novartis, which also includes contributions from the National Institute for Health Research (NIHR) and Oxford University, was announced Jan. 13 by Lord Prior, chair of NHS England. Researchers anticipate a large-scale clinical trial of the drug will start later this year, and, in the best case scenario, inclisiran could be widely available to patients by 2021.
“This innovative and groundbreaking collaboration could transform the health outlook of tens of thousands of people suffering from heart disease, by bringing together in a unique combination our ability to organize large scale clinical trials, to address highly complex manufacturing issues and to read a large population of patients,” Prior said in a statement. “It is a great illustration of how the UK Life Sciences Strategy can help both NHS patients and the wider economy.”
Early results from clinical trials suggest that if inclisiran were given to 300,000 patients each year, it could help prevent 55,000 heart attacks and strokes, potentially saving as many as 30,000 lives over the next 10 years. The drug works by harnessing the body’s natural process of RNA interference to prevent production of PCSK9 protein in the liver, enhancing the liver’s ability to remove LDL-cholesterol from the bloodstream.
The NHS and Novartis collaboration will also include the creation of an industry and academic consortium that will ideally improve the efficiency and cost of drug manufacturing in the U.K.
“This trial provides an opportunity to demonstrate how a highly streamlined trial can be conducted within the U.K. by combining elements of patients’ already diagnosed cardiovascular disease and received treatment through the successful ORION-4 trial with the high-throughput clinics developed for UK Biobank,” Martin Landray, a professor of medicine and epidemiology at Oxford, said in a release. “The trial will provide both a very reliable test of the efficiency and safety of inclisiran to support a population-health approach to the management of cholesterol, and act as an exemplar for future trials of other treatments in the U.K.”
After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.