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, EnglandJune 22, 2023 — 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.