Multicenter, Double-blind, Randomized, Placebo-controlled Trial of the Efficacy and Safety of a Single Bolus Administration of Non-immunogenic Recombinant Staphylokinase in Patients With Intermediate High-risk Pulmonary Embolism (FORPE-2)

Objective: to evaluate the efficacy and safety of the non-immunogenic recombinant staphylokinase with its single bolus administration in comparison with placebo in normotensive patients with intermediate high-risk pulmonary embolism (PE)

Start Date23 May 2024

Sponsor / Collaborator

Supergene Co., Ltd.

NCT05372718 / RecruitingPhase 3

Multicenter, Open-label, Randomized Clinical Trial of Efficacy and Safety of the Thrombolysis With Recombinant Non-immunogenic Staphylokinase (Fortelyzin®) in Patients With ALI vs Surgery

Objective: to evaluate the efficacy and safety of intra-arterial intrathrombus administration of the recombinant non-immunogenic staphylokinase (Fortelyzin®) in patients with acute limb ischemia (ALI) vs surgery.

Start Date26 Dec 2022

Sponsor / Collaborator

Supergene Co., Ltd.

NCT05135546 / TerminatedPhase 2/3

Inhaled Recombinant Non-immunogenic Staphylokinase vs Placebo in Patients With COVID-19 - FORRIF Trial

Objective: to evaluate the tolerability, safety and efficacy of inhaled usage of the Recombinant Non-immunogenic Staphylokinase (Fortelyzin®) vs placebo in patients with COVID-19.

Start Date27 Dec 2021

Sponsor / Collaborator

Supergene Co., Ltd.

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100 Clinical Results associated with Recombinant staphylokinase(Supergene Co. Ltd.)

100 Translational Medicine associated with Recombinant staphylokinase(Supergene Co. Ltd.)

100 Patents (Medical) associated with Recombinant staphylokinase(Supergene Co. Ltd.)

Literatures (Medical) associated with Recombinant staphylokinase(Supergene Co. Ltd.)

01 Oct 2024·Journal of Thrombosis and Haemostasis

Non-immunogenic recombinant staphylokinase versus alteplase for patients with massive pulmonary embolism: a randomised open-label, multicentre, parallel-group, non-inferiority trial FORPE

Article

Author: Yavelov, Igor S. ; Archakov, Alexander I ; Erlikh, Alexey D. ; Leontyev, Stanislav G. ; Shakhnovich, Roman M ; Ivanov, Sergey V. ; Leontyev, Stanislav G ; Semenov, Michail P. ; Shakhnovich, Roman M. ; Talibov, Oleg B. ; Semenov, Andrey M ; Kirienko, Alexander I ; Semenov, Michail P ; Semenov, Andrey M. ; Archakov, Alexander I. ; Tereschenko, Sergey N ; Yavelov, Igor S ; Beregovykh, Valery V ; Ivanov, Sergey V ; Yarovaya, Elena B ; Tereschenko, Sergey N. ; Markin, Sergey S ; Beregovykh, Valery V. ; Talibov, Oleg B ; Markin, Sergey S. ; Erlikh, Alexey D ; Yarovaya, Elena B. ; Kirienko, Alexander I.

BACKGROUNDNon-immunogenic staphylokinase is a modified recombinant staphylokinase with low immunogenicity, high thrombolytic activity, and fibrin selectivity.AIMTo assess the safety and efficacy of a single intravenous bolus of non-immunogenic staphylokinase compared to those of alteplase in patients with massive pulmonary embolism and haemodynamic instability.PATIENTS AND METHODSA randomised, open-label, multicentre, parallel-group, non-inferiority trial, the FORPE was conducted in Russia. A total of 310 patients aged 18 years and older with computed tomography pulmonary angiography confirmed diagnosis of massive pulmonary embolism and right ventricular dysfunction were included. The patients were randomly assigned to receive either non-immunogenic staphylokinase (15 mg) or alteplase (100 mg), both administered intravenously. The primary efficacy endpoint was death from all causes within seven days of randomisation.RESULTSA total of 155 patients were randomly assigned to receive non-immunogenic staphylokinase, and 155 received alteplase. In the non-immunogenic staphylokinase group, the primary efficacy endpoint was 2% in the intention-to-treat population, while in the alteplase group it was 3% (odds ratio [OR] 0.75, 95% confidence interval [CI] 0.11 to 4.49; p=1.00). The difference in the primary efficacy endpoint was 0.6% (95%CI -2.8 to 4.0). Thus, the lower limit of the 95%CI did not cross the margin of non-inferiority. No cases of major bleeding were recorded in the non-immunogenic staphylokinase group, whereas there were five cases of major bleeding (3%, p=0.09) in the alteplase group.CONCLUSIONSNon-immunogenic staphylokinase was non-inferior to alteplase in patients with massive pulmonary embolism. Future observational studies are needed to assess it safety and efficacy.

01 Jan 2023·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova

[Multicenter experience of using Fortelyzin during staged reperfusion therapy of acute ischemic stroke in anterior circulation].

Article

Author: Mukhamadieva, Y S ; Telyatnik, Yu A ; Podshivalov, I A ; Mingazetdinov, M A ; Timchenko, L V ; Zagidullin, B I ; Volodyukhin, M Yu ; Yusupov, R I ; Demin, T V ; Khasanova, D R ; Sinutin, V N

OBJECTIVETo evaluate the safety and efficacy of Fortelyzin in the performance of staged reperfusion therapy for acute ischemic stroke (intravenous thrombolytic therapy plus mechanical thrombectomy) in anterior circulation within the FORTA RF multicenter pilot study.MATERIAL AND METHODSThe study included 72 patients with acute ischemic stroke in anterior circulation, who underwent staged reperfusion therapy in four vascular centers of the Russian Federation from December 2019 to January 2023.RESULTSThe mean time from illness onset to hospitalization was 94.5 minutes in the Fortelyzin group and 97.2 min in the Actilyse group (p=0.78). The time from the moment of hospitalization to the admission of the patient to the X-ray operating room was significantly lower in the Fortelyzin group (p=0.002). The incidence of symptomatic hemorrhagic transformations in the Fortelyzin group was 6%, in the Actilyse group - 8% (p=0.75). A favorable functional outcome in the first group was observed in 47% of patients, in the control group in 42% (p=0.66). Mortality in both groups did not differ significantly and amounted to 22% and 25%, respectively.CONCLUSIONThe first results of the FORTA RF multicenter study demonstrate the safety and efficacy of Fortelyzin in staged reperfusion therapy compared to Actilyse.

01 Jan 2022·Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova

Nonimmunogenic staphylokinase in the treatment of acute ischemic stroke (FRIDA trial results)

Article

Author: Elemanov, U A ; Nikonova, A A ; Ponomarev, E A ; Kutsenko, V A ; Bobkov, V V ; Yarovaya, E B ; Korobeynikov, I V ; Nizov, A A ; Markin, S S ; Androfagina, O V ; Nikonov, A A ; Fedyanin, S A ; Nesterova, V N ; Yunevich, D S ; Girivenko, A I ; Lykov, Yu A ; Timchenko, L V ; Gorbachev, V I ; Korsunskaya, L L ; Vorobev, A A ; Martynov, M Yu ; Alasheev, A M ; Pribylov, S A ; Orlovsky, A A ; Aksentiev, S B ; Shamalov, N A ; Semikhin, A S ; Choroshavina, K V ; Archakov, A I ; Zakharov, S A ; Semenov, A M ; Popov, D V ; Greshnova, I V ; Chirkov, A N ; Dobrovolskiy, A V ; Semenov, M P ; Jadan, O N ; Chuprina, S E ; Gusev, E I ; Chefranova, Zh Yu ; Zhukovskaya, N V

AIM OF THE STUDYTo investigate the efficacy and safety of non-immunogenic staphylokinase (NS) compared with alteplase (A) in patients with acute ischemic stroke (AIS) within 4.5 h after symptom onset.MATERIAL AND METHODS336 patients with IS within 4.5 h after symptom onset were included in a randomized, open-label, multicenter, parallel-group, non-inferiority comparative trial of NS vs A (168 patients in each group). NS was administered as an intravenous bolus in a dose of 10 mg, regardless of body weight, over 10 s, A was administered as a bolus infusion in a dose of 0.9 mg/kg, maximum 90 mg over 1 hour. The primary efficacy endpoint was a favorable outcome, defined as a modified Rankin scale (mRS) score of 0-1 on day 90. Safety endpoints included all-cause mortality on day 90, symptomatic intracranial haemorrhage, and other serious adverse events (SAEs).RESULTSAt day 90, 84 (50%) patients reached the primary endpoint (mRS 0-1) in the NS group, 68 (41%) patients - in the A group (p=0.10, OR=1.47, 95% CI=0.93-2.32). The difference between groups NS and A was 9.5% (95% CI= -1.7-20.7) and the lower limit of the 95% CI did not cross the margin of non-inferiority (p_{non-inferiority}<0.0001). There were no significant differences in the frequency of deaths between the groups: on day 90, 17 (10%) patients in the NS group and 24 (14%) in the A group had died (p=0.32). There was a trend towards significant differences in the frequency of symptomatic intracranial haemorrhage: NS group - 5 (3%) patients, A group - 13 (8%) patients (p=0.087, OR=0.37, 95% CI=0.1-1.13). There were significant differences in the number of patients with SAEs: in the NS group - 22 (13%) patients, in the A group - 37 (22%) patients (p=0.044, OR=0.53, 95% CI=0.28-0.98).CONCLUSIONThe presented results of the FRIDA trial are the first in the world to use a drug based on NS in patients with IS. It has been shown that a single bolus (within 10 s) administration of NS at a standard dose of 10 mg, regardless of body weight, allows to conduct fast, effective and safe thrombolytic therapy in patients with IS within 4.5 h after symptom onset. In further clinical tials of NS, it is planned to expand the therapeutic window beyond 4.5 h after symptom onset in patients with IS.

100 Deals associated with Recombinant staphylokinase(Supergene Co. Ltd.)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Embolism	Phase 3	RU	Supergene Co., Ltd.	23 May 2024
Acute Lung Injury	Phase 3	RU	Supergene Co., Ltd.	26 Dec 2022
Limb ischemia	Phase 3	RU	Supergene Co., Ltd.	26 Dec 2022
Acute Ischemic Stroke	Preclinical	RU	Supergene Co., Ltd.	18 Mar 2017
ST Elevation Myocardial Infarction	Discovery	RU	Supergene Co., Ltd.	01 Oct 2014

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