FDY-5301 for Heart Attack

(IOCYTE AMI-3 Trial)

No longer recruiting at 66 trial locations

Overseen By Catherine Hutt

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Faraday Pharmaceuticals, Inc.

Must not be taking: Thyroid hormones, Thrombolytics

Disqualifiers: Thyroid disease, Renal dialysis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment, FDY-5301, can reduce deaths and heart failure events in individuals who have experienced an anterior STEMI, a specific type of heart attack. Participants will receive either FDY-5301 or a placebo (a harmless, inactive substance) through a single IV injection. Suitable candidates have experienced symptoms like chest pain or shortness of breath from this type of heart attack and plan to undergo a specific procedure (pPCI) within six hours of these symptoms. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on thyroid hormone replacement therapy or have used investigational drugs recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatment FDY-5301 is safe for people. In earlier studies, FDY-5301 did not cause any major side effects, indicating no serious health issues linked to the drug. One study found that FDY-5301 was well-tolerated and helped reduce damage from heart attacks. Overall, the evidence suggests that FDY-5301 is safe for those considering joining this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for heart attacks, like clot-busting drugs and stents, focus on restoring blood flow to the heart. But FDY-5301 works differently, targeting the inflammation that can damage heart tissue after a heart attack. Researchers are excited because FDY-5301 is administered as a single IV bolus injection, potentially offering a quick and convenient option. This unique approach could lead to better outcomes and faster recovery for patients experiencing a heart attack.

What evidence suggests that FDY-5301 might be an effective treatment for heart attack?

Research shows that FDY-5301, which participants in this trial may receive, might help treat heart attacks, especially for patients undergoing a procedure to open blocked arteries. Previous studies found that administering FDY-5301 intravenously before this procedure is safe and feasible. It may help by reducing heart damage and improving heart function. Early tests also suggest that FDY-5301 can aid in the better recovery of heart and muscle tissues. Overall, initial findings are promising for its effectiveness in treating heart attacks. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a specific type of heart attack called anterior STEMI, who can get treatment within 6 hours. It's not for those with life-threatening non-cardiac issues, pregnant or breastfeeding women, people on recent investigational drugs, thyroid disease patients, iodine allergy sufferers, individuals on dialysis, or anyone over 309 lbs.

Inclusion Criteria

Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved consent obtained for study participation

I am scheduled for a heart procedure within 6 hours of my first chest pain.

I had a heart attack in the front part of my heart with specific ECG changes.

Exclusion Criteria

I am on dialysis for kidney failure.

My doctor expects I have less than 1 year to live due to a non-heart related condition.

I am not pregnant or breastfeeding, and I have a negative pregnancy test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single IV bolus injection of FDY-5301 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for cardiovascular mortality and heart failure events

12 months

Regular visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• FDY-5301
• Placebo

Trial Overview The study tests if FDY-5301 reduces death from heart problems and acute heart failure in patients having a procedure to open blocked arteries after a severe type of heart attack. Participants will either receive FDY-5301 or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: FDY-5301 Experimental Treatment 1 Intervention

FDY-5301 will be administered as a single IV bolus injection.

Group II: Placebo Placebo Group 1 Intervention

Placebo (normal saline) will be administered as a single IV bolus injection.

Who Is Running the Clinical Trial?

Faraday Pharmaceuticals, Inc.

Lead Sponsor

Trials

3

Recruited

2,500+

Published Research Related to This Trial

ACE inhibitors, like ramipril, are effective not only in lowering blood pressure and treating heart failure but also in preventing ischemic events such as myocardial infarction (MI) in patients at risk, as shown in the large HOPE trial with a diverse group of participants.

The HOPE trial demonstrated that ramipril significantly reduces the risk of MI and other cardiovascular events in patients without heart failure or left ventricular dysfunction, suggesting its broader application in cardiovascular disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The anti-ischemic potential of angiotensin-converting enzyme inhibition: insights from the heart outcomes prevention evaluation trial. Pitt, B.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34774885/

A Randomized, double-blind, dose ranging clinical trial of ... Conclusions: Intravenous FDY-5301, delivered immediately prior to PPCI in acute STEMI, is feasible, safe, and shows potential efficacy. A larger ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167527321017861

A Randomized, double-blind, dose ranging clinical trial of ... Intravenous FDY-5301, delivered immediately prior to PPCI in acute STEMI, is feasible, safe, and shows potential efficacy.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03470441

A Study of Acute Myocardial Infarction Using FDY-5301 The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of three dose levels of FDY-5301 compared to placebo in STEMI patients ...

4. faradaypharma.com faradaypharma.com/press-releases/faraday-pharmaceuticals-announces-positive-top-line-results-from-phase-2-trial-of-fdy-5301-for-treatment-of-reperfusion-injury-following-a-stemi-heart-attack

Faraday Announces Positive Top-Line Results from Phase ... Preclinical studies of FDY-5301 have demonstrated its ability to reduce infarct size, improve cardiac function, and improve skeletal muscle ...

5. internationaljournalofcardiology.com internationaljournalofcardiology.com/article/S0167-5273(21)01786-1/abstract

A Randomized, double-blind, dose ranging clinical trial ... Intravenous FDY-5301 was delivered before re-opening of the infarct-related artery in 97% participants and increased plasma iodide levels ~1000 ...

6. faradaypharma.com faradaypharma.com/fdy5301

FDY-5301 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 ...