FDY-5301 for Heart Attack

(IOCYTE AMI-3 Trial)

Recruiting at 52 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

2351 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called FDY-5301 to see if it can help people who have had a severe heart attack. It focuses on patients undergoing a procedure to open blocked arteries and aims to improve their recovery and reduce complications.

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.

What data supports the effectiveness of the drug FDY-5301 for heart attack?

Research on ACE inhibitors, like ramipril, shows they can reduce deaths and prevent heart issues after a heart attack, suggesting similar benefits might be possible with FDY-5301 if it works in a similar way. ^{1 2 3 4 5}

Is FDY-5301 safe for humans?

The treatment, known as ACT-246475 in some studies, was found to be safe and well tolerated in healthy male subjects up to a dose of 32 mg, with no significant changes in blood tests, vital signs, or heart function. ^{6 7 8 9 10}

How is the drug FDY-5301 different from other heart attack treatments?

FDY-5301 is unique because it may offer a new mechanism of cardioprotection that differs from existing treatments like P2Y12 receptor antagonists, which are commonly used but may not provide additional benefits when combined with other similar strategies. This drug could potentially provide additive protection by targeting a different pathway, which is crucial for improving outcomes in heart attack patients. ^{7 11 12 13 14}

Eligibility Criteria

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

I am 18 years old or older.

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

ACE-inhibitor therapy after myocardial infarction--a new treatment strategy. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes of Implantable Cardioverter-Defibrillator Therapy in the SCD-HeFT. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Digitalis for treatment of congestive heart failure in patients in sinus rhythm: a systematic review and meta-analysis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Pharmacologic and Cardiac Implantable Electronic Device Therapies in Patients With Heart Failure and Reduced Ejection Fraction: A Systematic Review and Network Meta-Analysis. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Clinical Pharmacology of the Reversible and Potent P2Y12 Receptor Antagonist ACT-246475 After Single Subcutaneous Administration in Healthy Male Subjects. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

The impact of irreproducibility and competing protection from P2Y12 antagonists on the discovery of cardioprotective interventions. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Modern antiplatelet agents in coronary artery disease. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

In ACS, prasugrel reduces 30-day MACE and mortality vs. ticagrelor or clopidogrel; no differences for major bleeding. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

P2Y12 Inhibitors versus Aspirin Monotherapy for Long-term Secondary Prevention of Atherosclerotic Cardiovascular Disease Events: A Systematic Review and Meta-analysis. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Sonic hedgehog-induced functional recovery after myocardial infarction is enhanced by AMD3100-mediated progenitor-cell mobilization. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Baicalein, an active component of Scutellaria baicalensis Georgi, prevents lysophosphatidylcholine-induced cardiac injury by reducing reactive oxygen species production, calcium overload and apoptosis via MAPK pathways. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Recombinant frizzled1 protein attenuated cardiac hypertrophy after myocardial infarction via the canonical Wnt signaling pathway. [2019]

14. Germany pubmed.ncbi.nlm.nih.gov

Caspase-1 inhibition by VX-765 administered at reperfusion in P2Y12 receptor antagonist-treated rats provides long-term reduction in myocardial infarct size and preservation of ventricular function. [2022]