PlaqueTec, a company identifying endotype-specific biomarkers to advance precision medicine for coronary artery disease (CAD), announced today that it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to proceed with the BIOPATTERN trial after recruitment of the first ten patients with CHD.
The trial is designed to improve understanding of the pathobiology of atherosclerotic cardiovascular disease (ACVD) and how it varies between individuals, to help develop new 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 points along a patient’s diseased coronary artery. Thousands of proteins and other blood molecules will be measured in each sample, allowing assessment of trans-plaque gradients between samples. These data will be analyzed and used to build a more detailed picture of the disease and improve clinicians’ understanding of which proteins and biomolecules play a key role in the progression of CAD to heart attack.
The trial aims to recruit 300 patients with established CAD scheduled for coronary angiography. Patients will be recruited in eight UK NHS specialist heart centreswith four sites now open, including the main site Royal Papworth Hospital in Cambridge, UK, where Chief Investigator Dr Stephen Hoole is an interventional cardiologist, and Norfolk and Norwich University Hospital, Royal Bournemouth Hospital and Bristol Heart Institute.
The trial is being managed by the Papworth Trials Unit Collaboration in partnership 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).
Cardiovascular disease is the leading cause of death worldwide, with CAD being the most common type, accounting for 49% of the 18.6 million deaths related to cardiovascular disease in 2019.1 The BIOPATTERN trial will determine the safety and functionality of the LBS device and confirm trans-plaque protein signals observed in previous pilot studies. PlaqueTec then aims to use the collected data to create a new data platform based on new knowledge of disease location to enable the stratification of patients with distinct disease endotypes and the development of precision medicine approaches to improve treatment outcomes for patients with CHD.
“A population-based approach to cardiovascular risk management is generally currently used to treat patients with CAD and prevent progression to heart attack, while a more tailored precision medicine approach that takes into account each patient’s individual disease profile and health needs has exciting potential benefits. By better targeting new treatments to those patients at highest risk and most in need, we hope to effectively stabilize their disease and improve outcomes.” he said Dr Stephen Hoole, Consultant Cardiologist, Royal Papworth Hospital.
“The BIOPATTERN trial provides a new opportunity to use the LBS device to help us better understand and characterize CAD at the individual patient level and potentially enable better patient care by identifying new targeted precision medicine therapies to improve outcome of CHD patients in the future. .”
Reaching the 10 patient milestone and securing MHRA approval to continue recruitment into the BIOPATTERN trial is a huge success and enables us to continue our ambition to open a new frontier of precision medicine for patients with CAD. We are very grateful to all the patients and NHS staff who have made this milestone possible and we are now looking forward to progressing towards our target of 300 patients.
Dr. Simon Williams, General Manager, PlaqueTec
PlaqueTec LBS has been successfully validated in first-in-human and proof-of-concept trials.2 To learn more about the BIOPATTERN test, visit https://www.plaquetec.com/our-research.
- World Heart Federation (2023) “World Heart Expo 2023”. Available in: World-Heart-Report-2023.pdf (world-heart-federation.org)
- West, NEJ et al. (2017) ‘Transcutaneous sampling of local gradient biomolecules in atherosclerotic coronary plaques’, JACC: Basic to Translational Science, 2(6), pp. 646–654. doi:10.1016/j.jacbts.2017.07.007
