(oplunofusp) - 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

+ [6]

靶点-

作用机制

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

非在研适应症

哮喘支气管扩张肠道病毒感染+ [3]

原研机构

Ansun Biopharma, Inc.

在研机构

Ansun Biopharma, Inc.Nitto Avecia Pharma Services, Inc.

非在研机构

National Institute of Allergy & Infectious Diseases

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-

序列信息

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 review:

During 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 findings:

Expansion 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.

Summary:

Several 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 diseases : an official publication of the Infectious Diseases Society of America1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: Farthing, Jason ; Wolfe, Cameron R ; Hwang, Jimmy ; Dadwal, Sanjeet ; Hawley, Stephen ; Boeckh, Michael ; Wang, George ; Montanez, Paul ; Lawrence, Steven J ; Soave, Rosemary ; Chemaly, Roy F ; Marty, Francisco M ; Ho, Jennifer Hui-Chun ; Lewis, Stanley

Abstract:

Background:

There 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.

Methods:

Adult 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.

Results:

A 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).

Conclusions:

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

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
新型冠状病毒感染	临床3期	美国	Ansun Biopharma, Inc.	2019-05-23
新型冠状病毒感染	临床3期	中国	Ansun Biopharma, Inc.	2019-05-23
新型冠状病毒感染	临床3期	澳大利亚	Ansun Biopharma, Inc.	2019-05-23
新型冠状病毒感染	临床3期	丹麦	Ansun Biopharma, Inc.	2019-05-23
新型冠状病毒感染	临床3期	法国	Ansun Biopharma, Inc.	2019-05-23
新型冠状病毒感染	临床3期	中国香港	Ansun Biopharma, Inc.	2019-05-23
新型冠状病毒感染	临床3期	韩国	Ansun Biopharma, Inc.	2019-05-23
新型冠状病毒感染	临床3期	中国台湾	Ansun Biopharma, Inc.	2019-05-23
下呼吸道感染	临床3期	美国	Ansun Biopharma, Inc.	2019-05-23
下呼吸道感染	临床3期	中国	Ansun Biopharma, Inc.	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	觸選夢艱淵繭獵淵蓋壓(廠築艱鏇網網遞選構簾) = 願積糧蓋積衊鑰夢鑰齋憲築夢簾觸顧糧餘鬱範 (獵餘襯鹹鑰範遞簾鹹襯 ) 更多	积极	2021-08-02
				Placebo	觸選夢艱淵繭獵淵蓋壓(廠築艱鏇網網遞選構簾) = 製築繭築選艱遞壓築衊憲築夢簾觸顧糧餘鬱範 (獵餘襯鹹鑰範遞簾鹹襯 ) 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	選網衊鏇廠餘蓋醖壓積(淵鏇艱鑰廠餘夢顧膚鬱) = Three patients (19%) died within 30 days and 2 of these deaths were related to PIV infection. 蓋範糧襯遞鏇築選憲網 (糧鏇鑰選壓網積廠選選 )	积极	2016-05-01
NCT01113034 (Pubmed \| BMC Infect Dis) 人工标引	临床1期	哮喘	10	DAS181	觸鏇鑰廠壓選壓範範蓋(繭築鹹範襯糧蓋製窪簾) = No grade 3 or higher AEs occurred. 醖衊網艱築餘觸築鏇顧 (餘觸艱齋獵醖鏇淵糧鹽 ) 更多	积极	2016-02-01
				Placebo