sodium iodide (FDY-5301) / Faraday Pharma - LARVOL DELTA

Introducing FDY-5301 (ESC 2024) - "Sponsored by Faraday Pharmaceuticals, Inc"

Cardiovascular • Reperfusion Injury

Untapped and forgotten: controversies in the treatment of ischaemia-reperfusion injury (ESC 2024) - "- Explain how the investigational therapeutic FDY-5301 (sodium iodide) may have a mechanism of action that is differentiated from others targeting IRI. - Discuss how the Phase 2 data on FDY-5301 supported the decision to conduct the ongoing phase 3 outcomes trial, Iocyte AMI-3."

Cardiovascular • Reperfusion Injury

IOCYTE AMI-3: Evaluation in STEMI Patients Using FDY-5301 (clinicaltrials.gov) - P3 | N=2351 | Active, not recruiting | Sponsor: Faraday Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Congestive Heart Failure • Myocardial Infarction

IOCYTE AMI-3: Evaluation in STEMI Patients Using FDY-5301 (clinicaltrials.gov) - P3 | N=2300 | Recruiting | Sponsor: Faraday Pharmaceuticals, Inc. | Trial completion date: Jul 2024 ➔ Jun 2025 | Trial primary completion date: Jul 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Myocardial Infarction

FDY-5301: An Innovative Approach to The Treatment of Revascularization Coronary Injury. (PubMed, Cardiol Rev) - "Clinical trials have shown FDY-5301 administration to be safe, feasible, and fast-acting in its ability to increase plasma iodide concentration, and the results are favorable in demonstrating potential efficacy. FDY-5301 shows potential in its use to reduce the effects of reperfusion injury, and ongoing Phase 3 trials will allow for continued evaluation of its performance."

Journal • Cardiovascular • Myocardial Infarction • Reperfusion Injury

IOCYTE AMI-3: Evaluation in STEMI Patients Using FDY-5301 (clinicaltrials.gov) - P3 | N=2300 | Recruiting | Sponsor: Faraday Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Congestive Heart Failure • Myocardial Infarction

Evaluation of FDY-5301 in Major Trauma Patients in ICU (clinicaltrials.gov) - P2 | N=8 | Terminated | Sponsor: Faraday Pharmaceuticals, Inc. | Active, not recruiting ➔ Terminated; The study was terminated because of difficulty identifying patients that met the inclusion criteria, as well as logistical difficulties in opening clinical ICU study sites.

Trial termination • Mood Disorders

A Phase 3, randomized, double-blind, placebo-controlled, multicenter study of IV FDY-5301 in patients with a myocardial infarction (STEMI) Un estudio de fase 3, aleatorizado, doble ciego, controlado con placebo y multicéntrico de IV FDY-5301 en pacientes con un infarto de miocardio (IMEST) (clinicaltrialsregister.eu) - P3 | N=2300 | Ongoing | Sponsor: Faraday Pharmaceuticals, Inc.

New P3 trial • Cardiovascular • Myocardial Infarction

Evaluation of FDY-5301 in Major Trauma Patients in ICU (clinicaltrials.gov) - P2 | N=8 | Active, not recruiting | Sponsor: Faraday Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting | N=252 ➔ 8 | Trial completion date: Sep 2023 ➔ Mar 2022 | Trial primary completion date: Apr 2023 ➔ Mar 2022

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Mood Disorders

A Randomized, double-blind, dose ranging clinical trial of intravenous FDY-5301 in acute stemi patients undergoing primary PCI. (PubMed, Int J Cardiol) - P2, P2a | "Intravenous FDY-5301, delivered immediately prior to PPCI in acute STEMI, is feasible, safe, and shows potential efficacy. A larger trial is justified to test the effects of FDY-5301 on acute ischemia-reperfusion injury and clinical outcomes."

Clinical • Journal • Atrial Fibrillation • Cardiovascular • Myocardial Infarction • Pain • Reperfusion Injury • MMP2 • MRI

Evaluation of FDY-5301 in Major Trauma Patients in ICU (clinicaltrials.gov) - P2; N=252; Recruiting; Sponsor: Faraday Pharmaceuticals, Inc.; Trial completion date: Jan 2023 ➔ Sep 2023; Trial primary completion date: Jul 2022 ➔ Apr 2023

Clinical • Trial completion date • Trial primary completion date • Mood Disorders

IOCYTE AMI-3: Evaluation in STEMI Patients Using FDY-5301 (clinicaltrials.gov) - P3; N=2300; Not yet recruiting; Sponsor: Faraday Pharmaceuticals, Inc.; Trial completion date: May 2024 ➔ Jul 2024; Initiation date: Nov 2021 ➔ Mar 2022; Trial primary completion date: May 2024 ➔ Jul 2024

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Myocardial Infarction

IOCYTE AMI-3: Evaluation in STEMI Patients Using FDY-5301 (clinicaltrials.gov) - P3; N=2300; Not yet recruiting; Sponsor: Faraday Pharmaceuticals, Inc.

New P3 trial • Cardiovascular • Congestive Heart Failure • Myocardial Infarction

Evaluation of FDY-5301 in Major Trauma Patients in ICU (clinicaltrials.gov) - P2; N=252; Recruiting; Sponsor: Faraday Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Mood Disorders

Evaluation of FDY-5301 in Major Trauma Patients in ICU (clinicaltrials.gov) - P2; N=252; Not yet recruiting; Sponsor: Faraday Pharmaceuticals, Inc.; Trial completion date: Mar 2022 ➔ Jan 2023; Initiation date: Sep 2020 ➔ Feb 2021; Trial primary completion date: Sep 2021 ➔ Jul 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Mood Disorders

Evaluation of FDY-5301 in Major Trauma Patients in ICU (clinicaltrials.gov) - P2; N=252; Not yet recruiting; Sponsor: Faraday Pharmaceuticals, Inc.

Clinical • New P2 trial • Hematological Disorders • Mood Disorders