FDY-5301:
The first step in solving the reperfusion problem
Our lead compound,
FDY-5301, is a formulation of sodium iodide designed to reduce ischemia-reperfusion injury (IRI)
a phenomenon that occurs during revascularization of an ischemic tissue. Although restoring blood flow is necessary, the process of tissue reoxygenation paradoxically creates more tissue damage due to reactive oxygen species production and inflammation. In the case of a heart attack from an occluded coronary artery, IRI leads to increased infarct size, which may increase the risk of cardiovascular death or heart failure.
There is currently no approved therapeutic agent to limit IRI
FDY-5301 reduced tissue damage, infarct size, and inflammation in preclinical models of IRI and was studied in a Phase 2 clinical trial with encouraging results
Anterior STEMI typically represents an acute occlusion of the most vital coronary artery, the left anterior descending, and its reperfusion by PCI is believed to have the most IRI-mediated damage among heart attacks as well as risk of subsequent heart failure. A Phase 3 trial of FDY-5301 is now underway in anterior STEMI patients, representing an opportunity to be a first-in-class intervention for reducing cardiovascular mortality and heart failure.
