FDY-5301
With FDY-5301 we’re aiming to address an unmet clinical need: mitigating myocardial injury resulting from reperfusion during the treatment of myocardial infarction (MI)
FDY-5301 is a formulation of sodium iodide in clinical development to reduce ischemia-reperfusion injury (IRI) following myocardial infarction. MI remains a leading cause of morbidity and mortality worldwide, with IRI playing a significant role in infarct size and potentially the risk of subsequent heart failure.
Browse our clinical trial information to see FDY-5301’s steady progress toward becoming a possible first-in-class intervention attenuating IRI to reduce cardiovascular mortality and heart failure events.
FDY-8801
With FDY-8801 we’re seeking to target cachexia — a disease characterized by muscle wasting affecting millions of patients for which no FDA-approved medications exist
Cachexia, commonly associated with cancer and other severe chronic diseases, significantly impairs quality of life and prognostic outcomes for those patients suffering from it.
FDY-8801 is part of a class of agents intended for cachexia intervention.
Clinical Trials
Iocyte AMI
Phase 2
A randomized, double blind, placebo-controlled, multi-center trial
Evaluated the safety, efficacy, and pharmacokinetics of FDY-5301 in 120 patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI)
Reduction in inflammatory and cardiac biomarkers compared to placebo
FDY-5301 demonstrated reduction in:
Pro-Brain Natriuretic Peptide (NT-proBNP)— a marker of acute cardiac dysfunction
Myeloperoxidase (MPO)— a marker of inflammation
Matrix Metalloproteinase-2 (MMP2)— a marker of myocardial remodeling
Infarct size data
Ejection fraction data
Conclusions:
Ability to increase blood iodide levels by 1000-fold before reopening of the infarct-related coronary artery
Reduction in cardiac-related and inflammatory biomarkers compared to placebo
Associated with a trend towards reduced infarct size and preserved cardiac function
No drug-related serious adverse events or safety concerns
Easy one-time administration in the emergency setting of STEMI
Potential to reduce ischemia-reperfusion injury in STEMI patients, with justification for further testing in a larger, randomized clinical trial.
Iocyte AMI-3
Phase 3
A Phase 3 randomized, double-blind, placebo-controlled, multicenter study of intravenous FDY-5301
Assessing the efficacy and safety of FDY-5301 in reducing the incidence of heart failure and cardiovascular death in anterior STEMI patients undergoing primary PCI.
Targeted to enroll approximately 2,300 anterior STEMI patients across 150 centers globally, with an interim analysis that could lead to study adaptation.
Primary endpoint: The proportion of subjects who experience either cardiovascular mortality or a heart failure event within the year following STEMI.
Secondary endpoints:
- • The proportion of subjects who experience either all-cause mortality or a heart failure event through month 12
- • The total number of cardiovascular events defined as cardiovascular mortality and heart failure events through month 12
- • The proportion of subjects who experience a composite of the following specified non-fatal cardiovascular events: thromboembolic cerebral vascular accident (CVA), ventricular aneurysm/hemorrhage, recurrent myocardial infarction, or persistent arrhythmia requiring intervention through Month 12
- • Serum Troponin T at Day 3
Iocyte AMI-3 trial design
LEARN MORE about our lead program, FDY-5301
KOL Resource Center
A centralized repository of resources and up to the moment information to help keep you informed of our latest developments. Contact us for access.
