A Phase 3, randomized, double-blind, placebo-controlled, multicenter study of IV FDY-5301 in patients with a myocardial infarction (STEMI)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Faraday Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

12 Apr 2022 → 4 Sep 2025

Decision date (initial)

2024-08-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Faraday Pharmaceuticals, Inc.

External identifiers

EU CT number

2024-514372-40-00

EudraCT number

2021-001924-16

WHO UTN

U1111-1308-0435

ClinicalTrials.gov

NCT04837001

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Pharmacoeconomic, Safety

To assess the effect of FDY-5301 on cardiovascular mortality and heart
failure events in subjects with an anterior STEMI undergoing pPCI.

Secondary objectives 1

1. To assess the effect of FDY-5301 on other clinical outcomes such as allcause mortality and cardiovascular outcomes in subjects with an anterior STEMI undergoing pPCI

Conditions and MedDRA coding

Anterior ST-Elevation Myocardial Infarction

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 1. Age ≥ 18 years
2. 2. Anterior STEMI, based on: Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) and Electrocardiogram (ECG) criteria: • men > 40 years: ≥ 2 mm of ST elevation in V2 and V3 • men ≤ 40 years: ≥ 2.5 mm of ST elevation in V2 and V3 • women: ≥ 1.5 mm of ST elevation in V2 and V3
3. 3. Planned primary PCI to occur ≤ 6 hours of onset of persistent symptoms that caused the patient to pursue medical care for myocardial infarction
4. 4. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent obtained for study participation

Exclusion criteria 9

1. 1. Life expectancy of less than 1 year due to non-cardiac pathology
2. 2. Known thyroid disease or thyroid disorder, including subjects on thyroid hormone replacement therapy at the time of randomization
3. 3. Known allergy to iodine or the excipient of the investigational product (sodium chloride)
4. 4. Renal disease requiring dialysis
5. 5. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization
6. 6. Body weight > 140 kg (or 309 lbs)
7. 7. Use of thrombolytic therapy as treatment for the index STEMI event
8. 8. Use of investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to randomization or the use of investigational devices within 30 days prior to randomization
9. 9. Any clinically significant abnormality identified prior to randomization that in the judgment of the Investigator or Sponsor would preclude safe completion of the study, or confound the anticipated benefit of FDY-5301

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The proportion of subjects who experience either cardiovascular mortality (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), or a heart failure event through Month 12

Secondary endpoints 4

1. 1. The proportion of subjects who experience either all-cause mortality or a heart failure event through Month 12
2. 2. The total number of cardiovascular events defined as cardiovascular mortality and heart failure events through Month 12
3. 3. 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 (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
4. 4. Serum troponin T at Day 3

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Faraday Pharmaceuticals Inc.

Sponsor organisation

Faraday Pharmaceuticals Inc.

Address

1616 Eastlake Avenue East Suite 560

City

Seattle

Postcode

98102-3743

Country

United States

Scientific contact point

Organisation

Faraday Pharmaceuticals Inc.

Contact name

Tressa Randall

Public contact point

Organisation

Faraday Pharmaceuticals Inc.

Contact name

Tressa Randall

Third parties 5

Locations

9 EU/EEA countries · 86 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Serious breaches 1 · Art. 52 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 50 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications