Caristo Diagnostics Applauds FDA Approval of Colchicine as First Anti-Inflammatory Drug for Cardiovascular Disease

Colchicine's Approval Heightens the Need for Technologies Detecting Inflammation Specifically Related to Coronary Arteries

OXFORD, England, June 22, 2023 /PRNewswire/ -- Caristo Diagnostics Limited, a global leader in cardiac and vascular disease diagnostics and risk prediction, applauds the FDA's decision to approve colchicine as first anti-inflammatory drug for cardiovascular disease. Caristo reaffirms its commitment to lead innovations in CCTA based coronary inflammation detection and cardiovascular risk prediction, so every coronary inflammation patient can be identified and treated by appropriate therapy including the anti-inflammatory drug approved by the FDA.

According to the June 20 press release from AGEPHA Pharma USA, the U.S. Food and Drug Administration (FDA) has approved LODOCO® (Colchicine 0.5 mg) as the first anti-inflammatory atheroprotective cardiovascular treatment demonstrated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease. In a multi-national, randomized, double-blind, placebo-controlled clinical trial, 0.5 mg colchicine significantly reduces the overall risk of cardiovascular death, spontaneous myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization by 31% in comparison with the placebo group when added to high-intensity statins and other cardiovascular prevention therapies.

"Inflammation plays an important part in the development of atherosclerosis and is a strong predictor of cardiovascular disease progression", said Professor Charalambos Antoniades, Caristo Diagnostics Chief Scientific Officer, and British Heart Foundation Professor of Cardiovascular Medicine at the University of Oxford.  "The FDA approval of colchicine is an important tool for us to reduce coronary inflammation, a main culprit for heart attack."

Current methods used to assess inflammation include the measurement of circulating levels of inflammatory biomarkers, e.g., C-reactive protein (CRP), but these are not specific for coronary artery inflammation. Coronary computed tomography angiography (CCTA) can be used to detect anatomic high-risk plaque (HRP) features, but plaque inflammation is not visible. In contrast, Caristo Diagnostics' Ca-Ri Heart® technology applies advanced AI-driven techniques to CCTA scans to detect and quantify coronary artery inflammation with the Fat Attenuation Index (FAI) Score. This technology provides the basis to identify patients at high risk with coronary inflammation, for treatment prioritisation and monitoring. "Identifying patients with coronary artery inflammation at highest risk, independent of other clinical or CCTA features, will be crucial to achieve maximal patient benefit from newly-approved anti-inflammatory drugs," said Professor Keith Channon, Caristo Diagnostics Chief Medical Officer.

A meta-analysis published in JACC Cardiovascular Imaging¹ analysed prognostic value of common biomarkers of vascular inflammation. These biomarkers included common circulating inflammatory biomarkers (CRP, interleukin-6 and tumor necrosis factor-a), arterial positron emission tomography/ computed tomography, as well as coronary computed tomography angiography-derived biomarkers of vascular inflammation, including anatomical high-risk plaque features and perivascular adipose tissue (PVAT). The analysis concluded that among all biomarkers, PVAT exhibited the highest specificity and strongest prognostic value in predicting cardiovascular events.

Caristo Diagnostics was founded in 2018 to commercialize the proprietary CaRi-Heart® coronary inflammation diagnostic technology based on PVAT quantification. CaRi-Heart's AI algorithms allow trained health professionals to obtain measures of coronary inflammation from routine cardiac computed tomography angiography (CCTA) scans by using Caristo's Fat Attenuation Index (FAI) technology. The resulting FAI Score measures the risk of cardiac mortality due to coronary inflammation. Additionally, CaRi-Heart provides a long-term cardiac mortality risk by integrating coronary inflammation with standard clinic risk factors and the presence of coronary plaques.

About Caristo Diagnostics Limited
Caristo Diagnostics Limited is a global leader in cardiac and vascular disease diagnostics and risk prediction. Founded in 2018 as a spin-out company from the University of Oxford, the world's #1 research university, Caristo has developed a portfolio of imaging-based and AI-assisted platforms that can be applied to aid the prediction and diagnosis of heart attack, stroke, and diabetes. Caristo was highlighted by Nature in 2020 as one of the most exciting science-based companies to have emerged from academic labs. To-date Caristo has attracted over £23 million in venture capital investment (nearly US$30 million). Find Caristo online on its website, LinkedIn and Twitter.

About the CaRi-Heart® Technology
Named first of "7 Technologies That Could Change Heart Healthcare Forevermore" by the Robb Report, the CaRi-Heart technology is Caristo's flagship offering which aids coronary artery disease diagnosis with improved risk prediction. It applies advanced AI algorithms to routine cardiac CT scans to visualize and quantify coronary inflammation, which is the previously invisible root cause of the disease. Each patient's CaRi-Heart Report includes several clinical results: (1) the patient specific Fat Attenuation Index (FAI), a novel and patented biomarker for the measurement of coronary inflammation, which indicates the patient's risk in % relative to a matched peer group; (2) CaRi-Heart Risk, which assesses the absolute 8-year risk of a fatal heart attack (based on both coronary inflammation status and standard clinical risks factors); and (3) coronary plaque-specific characterization and quantification. The CaRi-Heart Analysis is supported by the CaRi-Heart software, which is cloud-based and agnostic to the type of scanner generating the routine cardiac CT images. The CaRi-Heart technology is CE Mark certified under the latest EU MDR with UKCA marking being received in September 2022. CaRi-Heart is limited to research use in the U.S. before the FDA grants marketing authorization.

Multiple patents underpinning CaRi-Heart technologies have been granted in major jurisdictions around the world. In addition, exceptional validation results showing CaRi-Heart's ability to aid the prediction of heart attacks have been published in leading medical journals including the Lancet, JACC, European Heart Journal, and Cardiovascular Research. CaRi-Heart validation and implementation projects have been supported by multiple UK government grants and awards, including the NHS AI Stage 3 Award for real-world evaluation and implementation of CaRi-Heart care pathway in multiple NHS hospitals. With its deep clinical insights, proven validity and implementation readiness, the CaRi-Heart Analysis Service and the resulting new care pathway can transform cardiac care around the world by aiding in better prediction and prevention of future heart attacks.

¹ JACC Cardiovasc Imaging. 2022 Mar;15(3):460-471. doi: 10.1016/j.jcmg.2021.09.014. Epub 2021 Nov 17

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