oplunofusp(oplunofusp) - 药物靶点：唾液酸_在研适应症：新型冠状病毒感染，下呼吸道感染，副流感病毒感染 NOS_专利_临床

概要

基本信息

药物类型

融合蛋白

别名

Farbefusp、Fludase、Oplunofusp

+ [8]

靶点

唾液酸

作用机制

sialic acid inhibitors、病毒内化抑制剂

治疗领域

感染呼吸系统疾病

在研适应症

新型冠状病毒感染下呼吸道感染副流感病毒感染 NOS+ [1]

非在研适应症

哮喘支气管扩张肠道病毒感染+ [2]

原研机构

Ansun Biopharma, Inc.

在研机构

Ansun Biopharma, Inc.

Nitto Avecia Pharma Services, Inc.

The Johns Hopkins University

非在研机构

艾昆纬医药科技（上海）有限公司

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评-

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结构/序列

Sequence Code 68267

来源: *****

关联

17

项与 oplunofusp 相关的临床试验

CTR20200160

/ Terminated临床3期

一项旨在检查DAS181治疗免疫功能低下受试者下呼吸道副流感病毒感染的有效性和安全性的III期、随机化、安慰剂对照研究

主要目的是检查DAS181治疗免疫功能低下受试者下呼吸道副流感病毒感染的有效性和安全性：证明DAS181相比安慰剂在临床结局方面的疗效；评估DAS181组相比安慰剂组PoI中DAS181治疗的安全性和耐受性。

开始日期2020-11-20

申办/合作机构

艾昆纬医药科技（上海）有限公司

NCT04460547

/ Unknown statusN/AIIT

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.

开始日期2020-07-25

申办/合作机构

Qassim University

NCT04354389

/ Withdrawn临床2/3期

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.

开始日期2020-07-25

申办/合作机构

Ansun Biopharma, Inc.

100 项与 oplunofusp 相关的临床结果

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100 项与 oplunofusp 相关的转化医学

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100 项与 oplunofusp 相关的专利（医药）

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42

项与 oplunofusp 相关的文献（医药）

2022-05-01·Current Opinion in Pulmonary Medicine3区 · 医学

Respiratory viral infections in the immunocompromised

3区 · 医学

Review

作者: 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.

2021-08-02·Clinical Infectious Diseases1区 · 医学

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

1区 · 医学

Article

作者: Chemaly, Roy F ; Hawley, Stephen ; Lewis, Stanley ; Soave, Rosemary ; Montanez, Paul ; Boeckh, Michael ; Wang, George ; Farthing, Jason ; Dadwal, Sanjeet ; Wolfe, Cameron R ; Hwang, Jimmy ; Lawrence, Steven J ; 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.

2021-06-01·Pediatric Infectious Disease Journal4区 · 医学

Novel Treatment of Infant With COVID-19 With the Sialidase Fusion Protein, DAS181

4区 · 医学

Article

作者: Frenck, Robert ; Phillips, Christine L ; Schulert, Grant ; Danziger-Isakov, Lara ; Khalil, Nadim ; Iliopoulos, Ilias ; Hui-Chin Ho, Jennifer ; Marsh, Rebecca ; Spearman, Paul ; Paulsen, Grant ; Divanovic, Allison ; Grimley, Michael ; Blum, Samantha

We describe the successful treatment of a 10-month-old female with respiratory distress secondary to Coronavirus disease 2019 (COVID-19) with the nebulized investigational drug, DAS181. Therapy was well tolerated, and the patient had minimal side effects. The patient’s respiratory distress and positive viral polymerase chain reaction rapidly resolved after initiation of therapy.

100 项与 oplunofusp 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15313

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
副流感病毒感染 NOS	临床3期	澳大利亚	Ansun Biopharma, Inc.	2019-05-23
副流感病毒感染 NOS	临床3期	韩国	Ansun Biopharma, Inc.	2019-05-23
副流感病毒感染 NOS	临床3期	中国	Ansun Biopharma, Inc.	2019-05-23
副流感病毒感染 NOS	临床3期	丹麦	Ansun Biopharma, Inc.	2019-05-23
副流感病毒感染 NOS	临床2期	意大利	艾昆纬医药科技（上海）有限公司	2019-05-23
副流感病毒感染 NOS	临床前	美国	艾昆纬医药科技（上海）有限公司	2019-05-23
副流感病毒感染 NOS	临床前	西班牙	艾昆纬医药科技（上海）有限公司	2019-05-23
副流感病毒感染 NOS	临床前	澳大利亚	艾昆纬医药科技（上海）有限公司	2019-05-23
副流感病毒感染 NOS	临床前	德国	艾昆纬医药科技（上海）有限公司	2019-05-23
副流感病毒感染 NOS	临床前	韩国	艾昆纬医药科技（上海）有限公司	2019-05-23

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01644877 (Pubmed \| Clin Infect Dis) 人工标引	临床2期	下呼吸道感染	111	DAS181	(衊糧積鏇齋簾鑰餘餘膚) = 醖觸壓齋夢築廠鹹壓鏇淵窪網淵鑰鹹鹽蓋鹽範 (選選齋襯淵糧醖鬱齋齋 ) 更多	积极	2021-08-02
				Placebo	(衊糧積鏇齋簾鑰餘餘膚) = 網選鏇憲築觸製積積選淵窪網淵鑰鹹鹽蓋鹽範 (選選齋襯淵糧醖鬱齋齋 ) 更多
Tandem Meetings ASTCT and CIBMTR2019	临床2期	下呼吸道感染	110	DAS181	(蓋憲醖鏇鹹繭廠顧繭遞) = 顧襯鹽鏇蓋壓鹹艱艱淵醖膚膚廠範鏇築膚選夢 (壓範範鹹襯淵簾壓願齋 ) 更多	积极	2019-03-01
				Placebo	(蓋憲醖鏇鹹繭廠顧繭遞) = 夢選窪齋淵膚衊鑰壓齋醖膚膚廠範鏇築膚選夢 (壓範範鹹襯淵簾壓願齋 ) 更多
NCT01924793 (Pubmed \| Biol Blood Marrow Transplant) 人工标引	临床2期	副流感病毒感染 NOS	16	DAS181	(襯齋糧憲膚夢壓艱構鬱) = Three patients (19%) died within 30 days and 2 of these deaths were related to PIV infection. 醖遞壓鏇範醖鹽廠鬱築 (憲壓窪廠願餘鑰夢餘網 )	积极	2016-05-01
NCT01113034 (Pubmed \| BMC Infect Dis) 人工标引	临床1期	哮喘	10	DAS181	(製齋構獵範廠選糧夢選) = No grade 3 or higher AEs occurred. 積簾構醖襯遞膚窪鬱淵 (簾糧獵憲醖齋觸構窪獵 ) 更多	积极	2016-02-01
				Placebo
Tandem Meetings ASTCT and CIBMTR2011	N/A	造血干细胞移植 \| 副流感病毒感染 NOS	1	DAS181	(構襯鏇壓襯鬱鏇膚網憲) = 齋衊壓膚築製製壓構鑰鏇簾繭積壓鹽鹹網範夢 (窪糧範憲鹹鹽鬱製繭齋 ) 更多	积极	2011-02-01