Fortelyzin (recombinant staphylokinase) / Supergene - LARVOL DELTA

Fortelizin in bridging therapy of acute ischemic stroke: data from the observational study FORPI registry (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "This study demonstrates the safety and efficacy of Fortelizin in bridging therapy of acute ischemic stroke in real-world clinical practice."

Journal • Observational data • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Fortelyzin for acute ischaemic stroke treatment in an extended (4.5 to 24 hours from the onset of symptoms) time window: data from the observational study FORPI registry (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "FORPI registry demonstrates similar data on the safety and efficacy of TLT with Fortelyzin in AIS patients both within 4.5 hours and beyond 4.5 hours from symptoms' onset."

Journal • Observational data • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

FRIDA-CT: Single Bolus Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset (clinicaltrials.gov) - P3 | N=990 | Not yet recruiting | Sponsor: Supergene, LLC

New P3 trial • Cardiovascular • Ischemic stroke

Fortelyzin for acute ischaemic stroke treatment: an open, prospective, non-interventional, observational study FORPI registry (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "The presented data confirm that intravenous thrombolysis with Fortelyzin is safe and effective in routine clinical practice when used within 4.5 h of AIS symptoms onset. These findings should encourage the wider usage of thrombolytic therapy for suitable patients."

Journal • Observational data • Cardiovascular • Ischemic stroke

Thrombolysis With the Nonimmunogenic Staphylokinase for Acute Ischemic Stroke in FORPI Registry: An Observational Study. (PubMed, Stroke) - "These safety and efficacy outcomes were comparable with FRIDA (Fortelyzin Randomized Investigation Compared With Alteplase) randomized clinical trial results. The presented data suggest that intravenous thrombolysis with the nonimmunogenic staphylokinase is safe and effective in routine clinical practice when used within 4.5 hours of AIS symptoms onset. These findings should encourage the wider usage of thrombolytic therapy with the nonimmunogenic staphylokinase for suitable patients."

Clinical • Journal • Observational data • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Ischemic stroke

Post-registration Trial of the Non-immunogenic Staphylokinase in Massive Pulmonary Embolism (clinicaltrials.gov) - P=N/A | N=20000 | Recruiting | Sponsor: Supergene, LLC

New trial • Cardiovascular • Pulmonary Embolism • Respiratory Diseases

Case series of successful thrombolytic therapy with the recombinant non-immunogenic staphylokinase in acute ischemic stroke beyond the standard therapeutic window (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "Further multicenter studies are needed to evaluate its application in the extended window. A paradigm shift from a «temporary» to a «tissue» therapeutic window based on perfusion neuroimaging is a promising direction."

Journal • Cardiovascular • Hematological Disorders • Ischemic stroke

Study of drug-drug interactions between Mexidol and thrombolytic drugs (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "The obtained results indicate that Mexidol does not affect the fibrinolytic activity of Actilyse, Metalyse and Fortelyzin."

Journal • Thrombosis

Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial (clinicaltrials.gov) - P3 | N=170 | Recruiting | Sponsor: Supergene, LLC | Trial completion date: Jul 2025 ➔ Dec 2026 | Trial primary completion date: May 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Cardiovascular

FORMAT-1: Single Bolus Recombinant Nonimmunogenic Staphylokinase Versus Single Bolus Tenecteplase (Metalyse) in STEMI (clinicaltrials.gov) - P3 | N=382 | Completed | Sponsor: Supergene, LLC | Unknown status ➔ Completed

Trial completion • Cardiovascular • Myocardial Infarction

Post-registration Trial of the Non-immunogenic Staphylokinase in Acute Ischemic Stroke (FORPI Registry) (clinicaltrials.gov) - P=N/A | N=23250 | Completed | Sponsor: Supergene, LLC | Recruiting ➔ Completed

Trial completion • Cardiovascular • Ischemic stroke

Post-registration Trial of the Non-immunogenic Staphylokinase in Acute Ischemic Stroke (FORPI Registry) (clinicaltrials.gov) - P=N/A | N=20000 | Recruiting | Sponsor: Supergene, LLC

New trial • Cardiovascular • Ischemic stroke

FORPE-2: Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism (clinicaltrials.gov) - P3 | N=486 | Recruiting | Sponsor: Supergene, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Pulmonary Embolism • Respiratory Diseases

Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism (clinicaltrials.gov) - P3 | N=486 | Not yet recruiting | Sponsor: Supergene, LLC

New P3 trial • Cardiovascular • Pulmonary Embolism • Respiratory Diseases

Multicenter experience of using Fortelyzin during staged reperfusion therapy of acute ischemic stroke in anterior circulation (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "The first results of the FORTA RF multicenter study demonstrate the safety and efficacy of Fortelyzin in staged reperfusion therapy compared to Actilyse."

Clinical • Journal • Cardiovascular • Hematological Disorders • Ischemic stroke

Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE (clinicaltrials.gov) - P3 | N=310 | Completed | Sponsor: Supergene, LLC | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Jun 2023 | Trial primary completion date: Nov 2023 ➔ Jun 2023

Trial completion • Trial completion date • Trial primary completion date • Cardiovascular • Pulmonary Embolism • Respiratory Diseases

Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE (clinicaltrials.gov) - P3 | N=310 | Recruiting | Sponsor: Supergene, LLC | Trial primary completion date: Dec 2022 ➔ Nov 2023

Trial primary completion date • Cardiovascular • Pulmonary Embolism • Respiratory Diseases

Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial (clinicaltrials.gov) - P3 | N=170 | Recruiting | Sponsor: Supergene, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular

Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial (clinicaltrials.gov) - P3 | N=170 | Not yet recruiting | Sponsor: Supergene, LLC | Initiation date: Jun 2022 ➔ Dec 2022

Trial initiation date • Cardiovascular

Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial (clinicaltrials.gov) - P3 | N=170 | Not yet recruiting | Sponsor: Supergene, LLC

New P3 trial

Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE (clinicaltrials.gov) - P3 | N=310 | Recruiting | Sponsor: Supergene, LLC | Trial completion date: Dec 2021 ➔ Dec 2023 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • Cardiovascular • Pulmonary Embolism • Respiratory Diseases

Recombinant Non-immunogenic Staphylokinase VS Alteplase for Massive PE a Randomized Non-inferiority Trial (clinicaltrials.gov) - P3; N=310; Recruiting; Sponsor: Supergene, LLC

Clinical • Head-to-Head • New P3 trial • Cardiovascular • Pulmonary Embolism • Respiratory Diseases

Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS (clinicaltrials.gov) - P3; N=336; Completed; Sponsor: Supergene, LLC; Recruiting ➔ Completed

Clinical • Trial completion • Cardiovascular • Ischemic stroke

Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS (clinicaltrials.gov) - P3; N=336; Recruiting; Sponsor: Supergene, LLC; Trial completion date: Dec 2018 ➔ Dec 2020; Trial primary completion date: Dec 2018 ➔ Sep 2020

Clinical • Trial completion date • Trial primary completion date • Cardiovascular • Ischemic stroke

New possibilities of thrombolytic therapy in patients with STEMI according to a multicenter clinical study FRIDOM1. (ESC 2019) - P3; "in the clinical trial FRIDOM1, it was demonstrated that a single bolus administration of Fortelyzin® at a dose of 15 mg in combination with anticoagulant and double antiaggregant therapy followed by PCI, is no less effective and safe than the use of Metalise®. TRIAL REGISTRATION: ClinicalTrials.gov NCT02301910"

Clinical