IOCYTE AMI-3
Research type
Research Study
Full title
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
IRAS ID
1004594
Contact name
Eric Obiri-Asante
Contact email
Sponsor organisation
Faraday Pharmaceuticals, Inc.
Eudract number
2021-001924-16
Clinicaltrials.gov Identifier
Research summary
Research Summary:
Purpose of the study: T to see if experimental drug, FDY-5301, could decrease the risk of experiencing heart failure (when the heart can't pump enough blood) or dying from heart-related causes.Study participants were followed for 12 months after a heart attack to assess these risks and evaluate the safety of FDY-5301.
What was tested:FDY-5301, a solution containing sodium iodide administered as a single injection into a vein. Iodide is a natural element needed for normal health. FDY-5301 quickly increased the amount of iodide normally found in the body for a short period of time.
People taking part in this study: 1,958 men and 359 women who were having a major, life-threatening heart attack took part in the study in over 13 countries.
Topline results: Results suggest the study drug did not provide a clear benefit in reducing the risk of experiencing heart failure or dying from heart-related causes.
Safety: Side effects for FDY-5301 and placebo were very similar in type, frequency and severity. People who received FDY-5301 did not experience more side effects - or more serious side effects - than those who received placebo. Overall, FDY-5301 was tolerated about the same as the placebo treatment.
Who sponsored this study? Faraday Pharmaceuticals, Inc. - 1616 Eastlake Ave E, Suite 560 -Seattle, Washington, USA, 98102,faradaypharma@gmail.com
Where was the study done? Canada,Czech Republic,Germany,Hungary,Israel,Italy,Netherlands,Poland,Portugal,Slovakia,Spain,United Kingdom,United States.
When was this study done? Between May2022 and Sep2025.
Randomization: Patients were randomly assigned to receive either FDY-5301 (the experimental study drug) or placebo (the inactive study drug, which is “normal saline” or salt water). Patients had an equal chance of receiving either FDY-5301 or placebo.
Blinding: This was a “double-blind” study. None of the patients, researchers, study doctors, or others staff knew what treatment each patient was receiving.
What were the side effects? Some patients experienced different types of side effects, which ranged in severity. Overall, 657 of 1,164 patients who received study drug and 620 of 1,153 patients who received placebo experienced at least one side effect. A total of 89 of 1,164 patients who received study drug and 112 of 1,153 who received placebo experienced at least one serious side effect. Two of these events (one in each treatment arm) were assessed as related to study drug by the Investigators but assessed as not related to study drug by Faraday. Both were events of hypotension that resolved the same day. Sometimes, a patient had more than one side effect or serious side effect at a time.
There were no meaningful differences in the side effects between the group receiving study drug and the group receiving placebo. The types of side effects and their severity matched what would normally be expected in adults recovering from a heart attack. The overall data shows none of the side effects appeared to be caused by the study drug.
Serious Side Effects - Death: During the first 28 days after receiving the study treatment drug, 15 patients died (6 of 1,164 who got the study drug and 9 of 1,153 who received placebo) (separate from patients who either experienced heart failure or died from heart‑related causes). Faraday and the study doctors do not believe these deaths were due to the experimental study drug. The deaths were mostly related to the serious medical conditions the patients had before enrolling in the study. Early deaths were mainly due to severe heart problems that happened shortly after the heart procedure. After the first two weeks, most deaths were related to serious infections, kidney failure, or the worsening of long-standing health problems. A few participants passed away at home where exact cause of death could not be determined. The study team reviewed all events carefully, and no unexpected patterns were found beyond what would be expected in a group of patients with advanced heart disease and other serious health conditions.
What were the overall results of the study? The percentage of patients who experienced heart failure or dying from heart-related causes were very similar between people who received the study drug and those who received placebo. These results show the experimental study drug did not provide a clear benefit over placebo in reducing deaths, heart failure, or serious heart-related events.
How has this study helped patients and researchers? The study was designed to prevent heart damage caused when blood flow returns after a heart attack, the results suggest this damage may be less important with current treatment methods. This study also showed most primary endpoint events were acute heart failure during the initial hospitalization, highlighting the importance of early in‑hospital events for future event‑driven heart attack studies. Are there plans for further studies?No further clinical studies with FDY-5301 are planned
Summary of Results:
"Purpose of the study: T to see if experimental drug, FDY-5301, could decrease the risk of experiencing heart failure (when the heart can't pump enough blood) or dying from heart-related causes.Study participants were followed for 12 months after a heart attack to assess these risks and evaluate the safety of FDY-5301.
What was tested:FDY-5301, a solution containing sodium iodide administered as a single injection into a vein. Iodide is a natural element needed for normal health. FDY-5301 quickly increased the amount of iodide normally found in the body for a short period of time.
People taking part in this study: 1,958 men and 359 women who were having a major, life-threatening heart attack took part in the study in over 13 countries.
Topline results: Results suggest the study drug did not provide a clear benefit in reducing the risk of experiencing heart failure or dying from heart-related causes.
Safety: Side effects for FDY-5301 and placebo were very similar in type, frequency and severity. People who received FDY-5301 did not experience more side effects - or more serious side effects - than those who received placebo. Overall, FDY-5301 was tolerated about the same as the placebo treatment.
Who sponsored this study? Faraday Pharmaceuticals, Inc. - 1616 Eastlake Ave E, Suite 560 -Seattle, Washington, USA, 98102,faradaypharma@gmail.com
Where was the study done? Canada,Czech Republic,Germany,Hungary,Israel,Italy,Netherlands,Poland,Portugal,Slovakia,Spain,United Kingdom,United States.
When was this study done? Between May2022 and Sep2025.
Randomization: Patients were randomly assigned to receive either FDY-5301 (the experimental study drug) or placebo (the inactive study drug, which is “normal saline” or salt water). Patients had an equal chance of receiving either FDY-5301 or placebo.
Blinding: This was a “double-blind” study. None of the patients, researchers, study doctors, or others staff knew what treatment each patient was receiving.
What were the side effects? Some patients experienced different types of side effects, which ranged in severity. Overall, 657 of 1,164 patients who received study drug and 620 of 1,153 patients who received placebo experienced at least one side effect. A total of 89 of 1,164 patients who received study drug and 112 of 1,153 who received placebo experienced at least one serious side effect. Two of these events (one in each treatment arm) were assessed as related to study drug by the Investigators but assessed as not related to study drug by Faraday. Both were events of hypotension that resolved the same day. Sometimes, a patient had more than one side effect or serious side effect at a time.
There were no meaningful differences in the side effects between the group receiving study drug and the group receiving placebo. The types of side effects and their severity matched what would normally be expected in adults recovering from a heart attack. The overall data shows none of the side effects appeared to be caused by the study drug.
Serious Side Effects - Death: During the first 28 days after receiving the study treatment drug, 15 patients died (6 of 1,164 who got the study drug and 9 of 1,153 who received placebo) (separate from patients who either experienced heart failure or died from heart‑related causes). Faraday and the study doctors do not believe these deaths were due to the experimental study drug. The deaths were mostly related to the serious medical conditions the patients had before enrolling in the study. Early deaths were mainly due to severe heart problems that happened shortly after the heart procedure. After the first two weeks, most deaths were related to serious infections, kidney failure, or the worsening of long-standing health problems. A few participants passed away at home where exact cause of death could not be determined. The study team reviewed all events carefully, and no unexpected patterns were found beyond what would be expected in a group of patients with advanced heart disease and other serious health conditions.
What were the overall results of the study? The percentage of patients who experienced heart failure or dying from heart-related causes were very similar between people who received the study drug and those who received placebo. These results show the experimental study drug did not provide a clear benefit over placebo in reducing deaths, heart failure, or serious heart-related events.
How has this study helped patients and researchers? The study was designed to prevent heart damage caused when blood flow returns after a heart attack, the results suggest this damage may be less important with current treatment methods. This study also showed most primary endpoint events were acute heart failure during the initial hospitalization, highlighting the importance of early in‑hospital events for future event‑driven heart attack studies. Are there plans for further studies?No further clinical studies with FDY-5301 are planned"REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0063
Date of REC Opinion
12 Apr 2022
REC opinion
Further Information Favourable Opinion