FDY-5301:
a potential reperfusion injury agent
Targeting a real-world problem for patients with STEMI
FDY-5301 is being developed to address an unmet need in cardiovascular medicine: the attenuation of reperfusion-induced damage that occurs during percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI).
Currently there are no approved therapeutics to limit IRI
Revascularization of the culprit coronary artery by PCI is standard of care for STEMI patients. However, the rapid tissue reoxygenation that follows PCI causes excessive production of reactive oxygen species (ROS). Although restoring blood flow is necessary in treating STEMI, the resulting ROS burst causes additional damage to cardiac tissue.
This phenomenon is known as ischemia-reperfusion injury (IRI). IRI may lead to increased infarct size, arrythmias, and heart failure.
Ischemia-reperfusion injury (IRI)
Reactive oxygen species are responsible for much of IRI, which progresses from cell injury to endothelial and microvascular dysfunction, to neutrophil migration and inflammation, and finally to infarct.
Our Goal:
Enhance intervention to preserve a better tomorrow
The real-world potential of FDY-5301
Ease of Use
In the acute myocardial infarction setting, FDY-5301 is administered as a convenient, single IV bolus prior to PCI that fits easily into the cath lab workflow.
Encouraging results
The Iocyte AMI Phase 2 clinical trial demonstrated that FDY-5301 reduced cardiac biomarkers of acute dysfunction, inflammation, and remodeling, and indicated a trend towards reducing infarct size and preserving ejection fraction.
Safety
In the Iocyte AMI trial, FDY-5301 showed no safety concerns, or serious drug related adverse events.
If Iocyte AMI-3 is successful, FDY-5301 might not only reduce cardiac mortality and heart failure rates but could significantly curtail associated healthcare costs.
The potential cost savings of a reduction in chronic heart failure patients and a decrease in hospitalizations is being evaluated.
Learn more about the science behind FDY-5301
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