Cardio Diagnostics Holdings Inc. (NASDAQ: CDIO) announced an agreement with AGEPHA Pharma to validate a precision-guided approach for treating inflammation-driven coronary heart disease (CHD). The collaboration will enable AGEPHA Pharma to supply LODOCO® (low-dose colchicine), its FDA-approved anti-inflammatory medication, for a Cardio Diagnostics-sponsored clinical study exploring the use of the company's PrecisionCHD™ blood test to identify patients with inflammation-driven CHD and assess their response to treatment over time.
Addressing the Growing Recognition of Inflammation in Cardiovascular Disease
Inflammation is increasingly recognized as a key driver of atherosclerosis and adverse cardiac events, prompting the clinical community to seek more informative tools to guide targeted treatment approaches. This need is particularly acute for conditions like INOCA (Ischemia with No Obstructive Coronary Arteries), which is gaining attention for its inflammatory underpinnings and diagnostic complexity.
The PrecisionCHD™ test represents an AI-powered integrated genetic-epigenetic diagnostic tool designed to aid in the diagnosis and management of CHD. The test evaluates six DNA methylation markers that map to modifiable drivers of CHD, including inflammation. For each patient, the PrecisionCHD™ test provides personalized insights into their specific molecular drivers that could help inform more targeted treatment and clinical decision making.
Leveraging Epigenetic Markers for Dynamic Monitoring
The dynamic nature of DNA methylation makes the PrecisionCHD™ test uniquely suited for non-invasive, repeatable monitoring of inflammation, offering a significant advantage over traditional imaging-based approaches. This capability positions the test as a potentially valuable tool for tracking treatment response and adjusting therapeutic strategies based on molecular changes.
Cardio Diagnostics is currently evaluating potential clinical sites for the study. The sponsored study will use PrecisionCHD™ to identify patients with inflammation-driven CHD who will be prescribed LODOCO® by a physician if clinically warranted. Patients will then be re-tested to examine changes in inflammation via DNA methylation signatures. The final study design will be outlined in partnership with the Principal Investigator of the clinical site(s) and registered as a clinical trial.
Precision Medicine Model for Cardiovascular Care
"This study reflects a precision medicine model where diagnosis and treatment are both guided by the patient's unique molecular insights," said Robert Philibert MD PhD, Chief Medical Officer at Cardio Diagnostics. "All interventions have potential adverse events. Fortunately, through the use of PrecisionCHD™, forward leaning clinicians can maximize the therapeutic index of cardiovascular treatment plans for their patients."
The collaboration between Cardio Diagnostics and AGEPHA Pharma represents a significant step toward implementing precision medicine approaches in cardiovascular care, potentially enabling clinicians to identify patients most likely to benefit from anti-inflammatory therapy while monitoring treatment response through molecular biomarkers.
