Delving into the Latest Updates on Dornase alfa biosimilar(Generium Pharmaceuticals) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Enzyme

Synonyms

Tigerase

Target

DNase I

Mechanism

DNase I stimulants(Deoxyribonuclease 1 stimulants)

Therapeutic Areas

Congenital DisordersDigestive System DisordersRespiratory Diseases+ [1]

Active Indication

Cystic Fibrosis

Inactive Indication

COVID-19Fibrosis

Originator Organization

Generium ZAO

Active Organization

Generium ZAO

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

RU (05 Mar 2019),

Cystic Fibrosis

Regulation-

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Gene Sequence

Sequence Code 146838

The sequence is quoted from: *****

COVID-19 pneumonia manifests among others with a thick bronhial secretion. It contains an increased number of neutrophil extracellular traps (NETs), formed during netosis. DNA is a major component in NETs. DNAse alfa (Pulmozyme®, Roche) is a recombinant human enzyme, registered for inhalations in patients with Cystic fibrosis, in which NETs are also a typical characteristic. DNAse alfa inhalations are typically well tolerated and with no major side effects. Some initial reports exist of using DNAse alfa inhalations in COVID-19 patients, that had benefitial effects. There are some trials registered with ClinicalTrials, investigating the usufulness of DNAse alfa in intubated patients, but the investigators have no knowledge of a trial, investigating the usufulness of this drug in patients receiving High Flow Nasal Oxygen therapy.

Start Date01 Dec 2021

Sponsor / Collaborator

UMC Ljubljana

NCT04459325 / CompletedPhase 3

A Prospective Open-label Study of the Tigerase® Efficacy and Safety as Part of Complex Therapy in Patients With COVID-19

It is a multicenter, open-label, randomized, parallel-group study of the efficacy and safety of Tigerase® (GENERIUM JSC, Russia) with standard therapy versus standard therapy in patients with COVID-19.

Start Date01 Jun 2020

Sponsor / Collaborator

Generium ZAO

NCT04468100 / CompletedPhase 3

A Multicenter Prospective Randomized Comparative Study of Pharmacokinetics, Clinical Efficacy and Safety of Tigerase® (JSC GENERIUM, Russia) vs. Pulmozyme® (Hoffmann-La Roche, Switzerland) as Part of Complex Therapy in Patients With Cystic Fibrosis

It is a multicenter, open-label, randomized, parallel-group study of the efficacy and safety of Tigerase® compared Pulmozyme® in patients with Cystic Fibrosis

Start Date30 Aug 2017

Sponsor / Collaborator

Generium ZAO

100 Clinical Results associated with Dornase alfa biosimilar(Generium Pharmaceuticals)

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100 Translational Medicine associated with Dornase alfa biosimilar(Generium Pharmaceuticals)

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100 Patents (Medical) associated with Dornase alfa biosimilar(Generium Pharmaceuticals)

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4

Literatures (Medical) associated with Dornase alfa biosimilar(Generium Pharmaceuticals)

01 Aug 2024·Current drug delivery

The Effect of PEGylation on Drugs’ Pharmacokinetic Parameters; from Absorption to Excretion

Review

Author: Gholikhani, Tooba ; Khajeei, Ali ; Javadzadeh, Yousef ; Masoomzadeh, Salar

Abstract::

Until the drugs enter humans life, they may face problems in transportation, drug delivery, and metabolism. These problems can cause reducing drug’s therapeutic effect and even increase its side effects. Together, these cases can reduce the patient's compliance with the treatment and complicate the treatment process. Much work has been done to solve or at least reduce these problems. For example, using different forms of a single drug molecule (like Citalopram and Escitalopram); slight changes in the drug’s molecule like Meperidine and α-Prodine, and using carriers (like Tigerase®). PEGylation is a recently presented method that can use for many targets. Poly Ethylene Glycol or PEG is a polymer that can attach to drugs by using different methods and resulting sustained release, controlled metabolism, targeted delivery, and other cases. Although they will not necessarily lead to an increase in the effect of the drug, they will lead to the improvement of the treatment process in certain ways. In this article, the team of authors has tried to collect and carefully review the best cases based on the PEGylation of drugs that can help the readers of this article.

01 Jan 2023·Vestnik otorinolaringologii

[Possibilities of using recombinant human deoxyribonuclease I in otorhinolaryngology].

Article

Author: Svistushkin, V M ; Eremeeva, K V ; Mironova, A R ; Sobolev, V P ; Sinkov, E V

ANNOTATION:

Dornase alfa (Pulmozyme, Tigerase) is a purified solution of recombinant human DNase, clinically developed for the treatment of pulmonary diseases in patients with cystic fibrosis (CF). The action of the drug is aimed at destroying the viscous secretion, rich in DNA strands of neutrophils, through their fragmentation, the density of the secretion decreases, and the aeration of the lower respiratory tract improves. The similarity of pathological processes with the formation of viscous exudate on the surface of the mucous membrane in diseases of the upper respiratory tract and ear initiated studies on the use of Dornase alpha in otorhinolaryngology.

MATERIAL AND METHODS:

The analysis of materials of domestic and foreign authors on the effectiveness of the use of the drug Dornase alfa in otorhinolaryngology was carried out.

RESULTS:

The review included 132 patients (10 studies) in whom Dornase alfa was used to treat CF-associated nasal and paranasal sinus diseases. Analysis of the literature revealed only 3 studies, one of which consisted of two parts, examining the effect of Dornase alpha on middle ear exudate: two studies were demonstrated in an animal model; one - in vitro on samples of middle ear effusion which were aspirated through a myringotomy incision from patients with recurrent acute otitis media; and one in clinical 40 patients (40 ears) for hydrolysis of exudate in the tympanostomy tubes.

CONCLUSION:

Analysis of studies on the use of Dornase alfa demonstrates an improvement in clinical symptoms in all patients with CF and chronic rhinosinusitis. In experimental studies on an animal model, as well as in vitro research on exudate from the middle ear, Dornase alfa has demonstrated high efficacy and safety. Dornase alfa is a drug with high potential, further research is needed for wider use in ENT practice, especially in otiatrics.

PloS oneQ3 · CROSS-FIELD

Comparison of biosimilar Tigerase and Pulmozyme in long-term symptomatic therapy of patients with cystic fibrosis and severe pulmonary impairment (subgroup analysis of a Phase III randomized open-label clinical trial (NCT04468100))

Q3 · CROSS-FIELD

ArticleOA

Author: Revel-Muroz, Nataliya P ; Zilber, Ilya E ; Magnitskaya, Olga V ; Kozyreva, Liliya S ; Kashirskaya, Nataliya Yu ; Ukhanova, Olga P ; Stepanenko, Tatiana A ; Akhtyamova-Givirovskaya, Nina E ; Gapchenko, Elena V ; Seitova, Gulnara N ; Markova, Oksana A ; Krasovsky, Stanislav A ; Ponomareva, Natalya D ; Kudlay, Dmitry A ; Asherova, Irina K ; Abdulganieva, Diana I ; Reutskaya, Elena M ; Amelina, Elena L ; Kudelya, Lubov M

Background:

Patients with cystic fibrosis (CF) need costly medical care and adequate therapy with expensive medicinal products. Tigerase® is the first biosimilar of dornase alfa, developed by the lead Russian biotechnology company GENERIUM. The aim of the manuscript to present post hoc sub-analysis of patients’ data with cystic fibrosis and severe pulmonary impairment of a larger comparative study (phase III open label, prospective, multi-centre, randomized study (NCT04468100)) of a generic version of recombinant human DNase Tigerase® to the only comparable drug, Pulmozyme®

Methods:

In the analyses included subgroup of 46 severe pulmonary impairment patients with baseline FEV1 level 40–60% of predicted (23 patients in each treatment group) out of 100 patients registered in the study phase III open label, prospective, multi-center, randomized study (NCT04468100), and compared efficacy endpoints (FEV1, FVC, number and time of exacerbations, body weight, St.George’s Respiratory Questionnaire) as well as safety parameters (AEs, SAEs, anti-drug antibody) within 24 treatment weeks.

Results:

All outcomes were comparable among the studied groups. In the efficacy dataset, the similar mean FEV1 and mean FVC changes for 24 weeks of both treatment groups were observed. The groups were also comparable in safety, all the secondary efficacy parameters and immunogenicity.

Conclusions:

The findings from this study support the clinical Tigerase® biosimilarity to Pulmozyme® administered in CF patients with severe impairment of pulmonary function.

100 Deals associated with Dornase alfa biosimilar(Generium Pharmaceuticals)

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