Delving into the Latest Updates on oplunofusp with Synapse

Overview

Basic Info

Drug Type

Fusion protein

Synonyms

Farbefusp, Fludase, Oplunofusp

+ [8]

Target

sialic acid

Action

inhibitors

Mechanism

sialic acid inhibitors, Virus internalization inhibitors

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

COVID-19Lower Respiratory Tract InfectionsParainfluenzae virus infection+ [1]

Inactive Indication

AsthmaBronchiectasisEnterovirus Infections+ [2]

Originator Organization

Ansun Biopharma, Inc.

Active Organization

Ansun Biopharma, Inc.

Nitto Avecia Pharma Services, Inc.

The Johns Hopkins University

Inactive Organization

IQVIA RDS (Shanghai) Co. Ltd.

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 68267

Source: *****

The primary objectives are to examine the efficacy and safety of DAS181 in the treatment of parainfluenza virus infections in the lower respiratory tract of immunocompromised subjects: to demonstrate the efficacy of DAS181 compared with placebo in clinical outcomes; and to evaluate the safety and tolerability of DAS181 treatment in the PoI in the DAS181 group compared with the placebo group.

Start Date20 Nov 2020

Sponsor / Collaborator

IQVIA RDS (Shanghai) Co. Ltd.

NCT04354389

/ WithdrawnPhase 2/3

DAS181 for COVID-19: A Phase II Multicenter, Randomized, Placebo-Controlled, Double-Blind Study

It is a multicenter, randomized, placebo-controlled, double-blind study. The study population is defined as subjects diagnosed with lower respiratory tract COVID-19 who require supplemental oxygen ≥2 LPM at the time of randomization.

Start Date25 Jul 2020

Sponsor / Collaborator

Ansun Biopharma, Inc.

NCT04460547

/ Unknown statusNot ApplicableIIT

Worldwide Trends on COVID-19 Research After the Declaration of COVID-19 Pandemic: An Observational Study

On 11th of March 2020, WHO characterized COVID-19 infection as a Pandemic. After the COVID-19 infection is declared as a Pandemic there was an outburst regarding COVID-19 Research. The Research interest led to registration of Interventional and Observational studies world wide. There are constant efforts by Health care workers to seek information regarding the Interventional and Observational studies which can help in decision making regarding effective handling of COVID-19 infected patients. It is also important to track on the happenings in various frontiers of COVID-19 Research in view of historical interest and clinical relevance. This Observational Cross sectional study aims to explore the completed Researches in WHO-compliant registries to understand the trends of COVID-19 Research. This study aims to get a birds eye view of ongoing COVID-19 Research scenario worldwide. This study results can directly benefit the worldwide Academicians and Health Care Professionals to understand the ongoing COVID-19 Research trends.

Start Date25 Jul 2020

Sponsor / Collaborator

Qassim University

100 Clinical Results associated with oplunofusp

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100 Translational Medicine associated with oplunofusp

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100 Patents (Medical) associated with oplunofusp

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43

Literatures (Medical) associated with oplunofusp

01 Jan 2025·Mucosal Immunology

Sialidase fusion protein protects against influenza infection in a cigarette smoke-induced model of COPD

Article

Author: Knight, John M ; Armstrong, Dominique ; Wang, Max ; Kheradmand, Farrah ; Chang, Cheng-Yen ; Hawley, Stephen ; Chang, Nancy ; Corry, David B ; Gale, Trevor V

First- and secondhand smokers are at an increased risk for influenza virus (IFV)-related respiratory failure and death. Despite approved influenza antiviral treatments, there is an unmet need for treatments that can improve outcomes in populations at risk for respiratory failure, including tobacco users with Chronic Obstructive Pulmonary Disease (COPD). Here we show that the sialidase fusion protein, DAS181, reduced viral burden, mitigated inflammation, and attenuated lung function loss, consistent with broad-spectrum anti-influenza responses in a mouse model of COPD and IFV-A infection. Treatment with DAS181 reprogramed the sialic acid-binding immunoglobulin-like lectins (Siglecs) in alveolar macrophages, increased expression of phagocytic marker CD169, and downregulated inhibitory Siglec-F and Siglec-H molecules. Upon reinfection, mice treated with DAS181 showed activated and protective memory response in the lungs. Collectively, we show that this sialidase fusion protein promotes a beneficial immunomodulatory reaction in the lungs, supporting a new IFV-A therapeutic option for at-risk smokers.

01 May 2022·Current Opinion in Pulmonary MedicineQ3 · MEDICINE

Respiratory viral infections in the immunocompromised

Q3 · MEDICINE

Review

Author: Ison, Michael G

Purpose of reviewDuring much of the COVID-19 pandemic, respiratory viruses other than SARS-CoV-2 did not infect immunocompromised patients. As mitigation strategies lighten, there has been a rapid resurgence of respiratory viruses globally. This review will summarize our current options for the management of the common respiratory viruses in transplant recipients.Recent findingsExpansion of the availability and increased utilization of multiplex molecular assays have allowed the recognition of the scope of respiratory virus infections in the transplant populations. New antivirals for influenza, respiratory syncytial virus (RSV), parainfluenza virus (PIV) and adenovirus show promise to improve outcomes of these important infections.SummarySeveral new antiviral agents, including combination therapy of oseltamivir as well as baloxavir for influenza, fusion and nucleoprotein inhibitors for RSV, DAS181 for PIV and brincidofovir for adenovirus, hold promise to speed clearance of the virus, improve clinical outcomes and reduce the risk of resistance emergence.

02 Aug 2021·Clinical Infectious DiseasesQ1 · MEDICINE

DAS181 Treatment of Severe Lower Respiratory Tract Parainfluenza Virus Infection in Immunocompromised Patients: A Phase 2 Randomized, Placebo-Controlled Study

Q1 · MEDICINE

Article

Author: Chemaly, Roy F ; Hawley, Stephen ; Lewis, Stanley ; Soave, Rosemary ; Montanez, Paul ; Boeckh, Michael ; Wang, George ; Farthing, Jason ; Dadwal, Sanjeet ; Wolfe, Cameron R ; Lawrence, Steven J ; Hwang, Jimmy ; Marty, Francisco M ; Ho, Jennifer Hui-Chun

AbstractBackgroundThere are no antiviral therapies for parainfluenza virus (PIV) infections. DAS181, a sialidase fusion protein, has demonstrated activity in in vitro and in animal models of PIV.MethodsAdult immunocompromised patients diagnosed with PIV lower respiratory tract infection (LRTI) who required oxygen supplementation were randomized 2:1 to nebulized DAS181 (4.5 mg/day) or matching placebo for up to 10 days. Randomization was stratified by need for mechanical ventilation (MV) or supplemental oxygen (SO). The primary endpoint was the proportion of patients reaching clinical stability survival (CSS) defined as returning to room air (RTRA), normalization of vital signs for at least 24 hours, and survival up to day 45 from enrollment.ResultsA total of 111 patients were randomized to DAS181 (n = 74) or placebo (n = 37). CSS was achieved by 45.0% DAS181-treated patients in the SO stratum compared with 31.0% for placebo (P = .15), whereas patients on MV had no benefit from DAS181. The proportion of patients achieving RTRA was numerically higher for SO stratum DAS181 patients (51.7%) compared with placebo (34.5%) at day 28 (P = .17). In a post hoc analysis of solid organ transplant, hematopoietic cell transplantation within 1 year, or chemotherapy within 1 year, more SO stratum patients achieved RTRA on DAS181 (51.8%) compared with placebo (15.8%) by day 28 (P = .012).ConclusionsThe primary endpoint was not met, but post hoc analysis of the RTRA component suggests DAS181 may have clinical activity in improving oxygenation in select severely immunocompromised patients with PIV LRTI who are not on mechanical ventilation.Clinical Trials Registration. NCT01644877.

100 Deals associated with oplunofusp

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15313

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	Hong Kong	Ansun Biopharma, Inc.	23 May 2019
COVID-19	Phase 3	China	Ansun Biopharma, Inc.	23 May 2019
Lower Respiratory Tract Infections	Phase 3	Australia	Ansun Biopharma, Inc.	23 May 2019
Lower Respiratory Tract Infections	Phase 3	South Korea	Ansun Biopharma, Inc.	23 May 2019
Lower Respiratory Tract Infections	Phase 3	Denmark	Ansun Biopharma, Inc.	23 May 2019
Lower Respiratory Tract Infections	Phase 3	United States	Ansun Biopharma, Inc.	23 May 2019
Lower Respiratory Tract Infections	Phase 3	Hong Kong	Ansun Biopharma, Inc.	23 May 2019
Lower Respiratory Tract Infections	Phase 3	China	Ansun Biopharma, Inc.	23 May 2019
Lower Respiratory Tract Infections	Phase 3	France	Ansun Biopharma, Inc.	23 May 2019
Lower Respiratory Tract Infections	Phase 3	Taiwan Province	Ansun Biopharma, Inc.	23 May 2019

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01644877 (Pubmed \| Clin Infect Dis) Manual	Phase 2	Lower Respiratory Tract Infections	111	DAS181	(licyzejyoe) = hcomzqgamj gmabdagfir (qeifzbcmnz ) View more	Positive	02 Aug 2021
				Placebo	(licyzejyoe) = twygklbcib gmabdagfir (qeifzbcmnz ) View more
Tandem Meetings ASTCT and CIBMTR2019	Phase 2	Lower Respiratory Tract Infections	110	DAS181	(nqypkmsfgv) = ffybeskkvv xfmcackvua (nmkvdacdwk ) View more	Positive	01 Mar 2019
				Placebo	(nqypkmsfgv) = qdsmyqlivd xfmcackvua (nmkvdacdwk ) View more
NCT01924793 (Pubmed \| Biol Blood Marrow Transplant) Manual	Phase 2	Parainfluenzae virus infection	16	DAS181	(cbcwukjzzx) = Three patients (19%) died within 30 days and 2 of these deaths were related to PIV infection. gdrthwcppn (ykughhowrn )	Positive	01 May 2016
NCT01113034 (Pubmed \| BMC Infect Dis) Manual	Phase 1	Asthma	10	DAS181	(ruqegamvmt) = No grade 3 or higher AEs occurred. xmiivtxwnr (qedvsuqxdr ) View more	Positive	01 Feb 2016
				Placebo
Tandem Meetings ASTCT and CIBMTR2011	Not Applicable	Hematopoietic stem cell transplantation \| Parainfluenzae virus infection	1	DAS181	(rmdznsrhxh) = vudheuwscm qcynwvuqvi (xtrorewdxy ) View more	Positive	01 Feb 2011

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

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oplunofusp

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation