Phase 3 Randomized Double-Blind Placebo-Controlled Study of Intravenous Sodium Iodide (FDY-5301) in Anterior ST-Elevation Myocardial Infarction Patients

The primary objective of this study is to evaluate the effect of **FDY-5301** on cardiovascular mortality and heart failure events in patients with an anterior ST-Elevation Myocardial Infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI). This is clinically relevant as it aims to determine the potential of FDY-5301 to improve survival and reduce heart failure incidents in a high-risk patient population, thereby potentially enhancing post-infarction outcomes.

Secondary objectives include assessing the effect of FDY-5301 on other clinical outcomes such as all-cause mortality and additional cardiovascular outcomes in the same patient group. These objectives are important for understanding the broader impact of FDY-5301 on patient health and recovery following an anterior STEMI.

The clinical trial involves a total of **534 participants** diagnosed with **Anterior ST-Elevation Myocardial Infarction** (STEMI). The study population includes both male and female subjects, aged 18 years and older, who are experiencing symptoms of myocardial ischemia and meet specific electrocardiogram criteria. Participants were selected based on their planned primary percutaneous coronary intervention (pPCI) occurring within 6 hours of symptom onset. The trial includes a vulnerable population, indicating that special ethical considerations are in place. The participants' general health status is characterized by the acute condition of anterior STEMI, and lifestyle factors such as diet and physical activity are not specified in the available data. The selection process ensures that all participants have provided informed consent approved by an Institutional Review Board or Independent Ethics Committee.

The clinical trial is a **Phase 3**, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy of intravenous FDY-5301 in patients with **anterior ST-elevation myocardial infarction** (STEMI). The primary objective is to assess the effect of FDY-5301 on cardiovascular mortality and heart failure events in subjects undergoing primary percutaneous coronary intervention (pPCI). The trial is expected to conclude by June 30, 2025, with recruitment having commenced on May 12, 2022.

Participants will be randomly assigned to receive either the investigational drug, FDY-5301, or a placebo, both administered as a solution for injection. The placebo is formulated to visually match the investigational product and consists of a standard saline solution. The study will involve multiple visits, starting with a screening visit to confirm eligibility based on criteria such as age (≥18 years), presence of anterior STEMI, and planned pPCI within six hours of symptom onset. Informed consent approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) is required for participation.

Following the screening, participants will undergo a series of follow-up visits to monitor their health status and collect data on primary and secondary endpoints. The primary endpoint is the proportion of subjects experiencing cardiovascular mortality or a heart failure event through Month 12. Secondary endpoints include all-cause mortality, the total number of cardiovascular events, and specific non-fatal cardiovascular events. Serum troponin T levels will also be measured on Day 3 to assess myocardial injury.

The expected duration of participant involvement is up to 12 months, with conditions for early termination including withdrawal of consent, adverse events, or protocol non-compliance. The study aims to provide valuable insights into the potential benefits of FDY-5301 in reducing adverse cardiovascular outcomes in patients with anterior STEMI.

The clinical trial involves the administration of **FDY-5301**, an experimental medication formulated as a **solution for injection**. The active substance in FDY-5301 is **sodium iodide**, a chemical compound. The medication is administered intravenously, with a dosage of 2 mg/kg. The maximum daily dose and total dose are both set at 2 mg/kg, and the treatment period is limited to one day. The medication is provided by Faraday Pharmaceuticals, Inc. Compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the protocol.

The study also includes a **placebo** treatment, which is designed to visually match the FDY-5301 injection drug product. The placebo is formulated to resemble a standard saline solution, consisting of sodium chloride and water for injection. This placebo is administered intravenously, following the same schedule as the experimental medication, to maintain the double-blind nature of the trial. The placebo serves as a comparator to evaluate the efficacy and safety of FDY-5301 in patients with anterior ST-Elevation Myocardial Infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI).

Efficacy in the clinical trial titled "IOCYTE AMI-3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intravenous FDY-5301 in Patients with an Anterior ST-Elevation Myocardial Infarction" will be assessed using both primary and secondary endpoints. The primary endpoint is the proportion of subjects who experience either cardiovascular mortality or a heart failure event through Month 12. Cardiovascular mortality is defined as deaths which are sudden and due to presumed arrhythmia, or deaths due to presumed or confirmed thromboembolic cerebral vascular accident, presumed or confirmed pulmonary embolism, cardiac rupture, heart failure, recurrent myocardial infarction (e.g., remote or stent thrombosis), and deaths due to procedural efforts to treat these defined cardiac events.

Secondary endpoints include 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, and the proportion of subjects who experience a composite of specified non-fatal cardiovascular events such as thromboembolic cerebral vascular accident (CVA), ventricular aneurysm/hemorrhage, recurrent myocardial infarction (e.g., remote or stent thrombosis), or persistent arrhythmia requiring intervention (e.g., ventricular fibrillation, sustained ventricular tachycardia, or bradyarrhythmia requiring intervention) through Month 12. Additionally, **serum troponin T** levels will be measured at Day 3 as part of the secondary endpoints.