PlaqueTec Recruits First 10 Patients in BIOPATTERN Trial

PlaqueTec has received the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) approval to continue its BIOPATTERN trial after recruiting the first 10 patients with coronary artery disease (CAD). The trial aims to better understand the pathobiology of atherosclerotic cardiovascular diseases (ACVD) and the ways it varies between individuals, to help develop 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 trans-plaque gradients between samples. These data will be analyzed and used to generate a more detailed picture of the disease and enhance clinicians’ understanding of the specific proteins and biomolecules that play key roles in CAD progression towards a heart attack.
 
The trial will recruit 300 CAD patients who have been scheduled for a coronary angiogram. Patients will be recruited across eight U.K. National Health Service specialist cardiac centers—with four sites now open—including lead site Royal Papworth Hospital in Cambridge, U.K., where Chief Investigator Dr. 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 Professor Peter Libby (Mallinckrodt Professor of Medicine, Harvard Medical School, and president of the International Atherosclerosis Society).
 
CVD is the leading cause of death worldwide, with CAD being the most common type, accounting for 49% of the 18.6 million CVD-related deaths in 2019.¹ The BIOPATTERN trial will establish the safety and functionality of the LBS device and confirm trans-plaque 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 CAD.
 
“A population approach to managing cardiovascular risk is generally used at present to treat CAD 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, a consultant cardiologist, Royal Papworth Hospital. “The BIOPATTERN trial provides a novel opportunity to use the LBS device to help us better understand and characterise CAD 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 CAD in the future.”
 
“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 CAD. 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,” PlaqueTec General Manager Dr. Simon Williams stated.
 
The PlaqueTec LBS has been successfully validated in first-in-human and proof-of-concept trials.² 
 
References
¹ World Heart Federation (2023) ‘World Heart Report 2023’. Available at: World-Heart-Report-2023.pdf (world-heart-federation.org)
² West, N.E.J. et al. (2017) ‘Percutaneous sampling of local biomolecule gradients across coronary artery atherosclerotic plaques’, JACC: Basic to Translational Science, 2(6), pp. 646–654. doi:10.1016/j.jacbts.2017.07.007