PlaqueTec has received approval from UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to continue its BIOPATTERN trial following recruitment of the first 10 patients with coronary artery disease.
The trial has been designed to improve understanding of the pathobiology of atherosclerotic cardiovascular diseases (ACVD) and how it varies between individuals, to aid the development of novel therapies and treatment approaches.
The BIOPATTERN trial will use PlaqueTec’s proprietary blood sampling device, the Liquid Biopsy System (LBS), to collect samples at multiple sites along a patient’s diseased coronary artery. Thousands of proteins and other blood molecules will be measured in each sample, enabling the assessment of transplaque gradients between samples. These data will be analysed and used to generate a more detailed picture of the disease and enhance clinicians’ understanding of which proteins and biomolecules play key roles in coronary artery disease progression towards heart attack.
The trial aims to recruit 300 patients with established coronary artery disease who have been scheduled for a coronary angiogram. Patients will be recruited across eight UK National Health Service (NHS) specialist cardiac centres, with four sites now open, including lead site Royal Papworth Hospital in Cambridge, UK, where chief investigator Stephen Hoole is an interventional cardiologist, and Norfolk and Norwich University Hospital, Royal Bournemouth Hospital, and the Bristol Heart Institute. The trial is managed by Papworth Trials Unit Collaboration in collaboration with PlaqueTec and is overseen by a trial steering committee chaired by Peter Libby (Harvard Medical School, Boston, USA), president of the International Atherosclerosis Society (IAS).
Cardiovascular disease is the leading cause of death worldwide, with coronary artery disease being the most common type, accounting for 49% of the 18.6 million cardiovascular disease-related deaths in 2019. The BIOPATTERN trial will establish the safety and functionality of the LBS device and confirm transplaque protein signals seen in earlier pilot studies. PlaqueTec then aims to use the data collected to generate a new data platform based on novel site-of-disease insights to enable the stratification of patients with distinct disease endotypes and the development of precision medicine approaches to improve treatment outcomes for patients with coronary artery disease.
“A population approach to managing cardiovascular risk is generally used at present to treat coronary artery disease patients and prevent progression to heart attack, whereas a more tailored, precision medicine approach that accounts for each patient’s individual disease profile and health needs has exciting potential benefits. By better targeting of new therapies to those patients at highest risk and who most need them, we hope to efficiently stabilise their disease and improve outcomes,” said Hoole. “The BIOPATTERN trial provides a novel opportunity to use the LBS device to help us better understand and characterise coronary artery disease on an individual patient level and potentially enable better patient care by identifying novel precision medicine targeted treatments to improve the outcome of patients with coronary artery disease in the future.”
Simon Williams, general manager, PlaqueTec, said: “Reaching the 10-patient landmark and securing MHRA approval to continue to recruit to the BIOPATTERN trial is a huge success and enables us to pursue our ambition of opening a new frontier of precision medicine for patients with coronary artery disease. We are very grateful to all the patients and NHS site staff who have made this landmark possible and now look forward to progressing towards the 300-patient target.”
