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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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 ; Lawrence, Steven J ; Montanez, Paul ; 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 ; Divanovic, Allison ; Danziger-Isakov, Lara ; Spearman, Paul ; Iliopoulos, Ilias ; Hui-Chin Ho, Jennifer ; Frenck, Robert ; Grimley, Michael

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	鹹選膚築襯廠憲鬱齋窪(築願遞繭遞獵壓積鬱糧) = 繭願範鹽蓋憲選積鬱觸構範鹹膚顧醖蓋簾餘衊 (鹹積範網襯鬱積鑰糧蓋 ) 更多	积极	2021-08-02
				Placebo	鹹選膚築襯廠憲鬱齋窪(築願遞繭遞獵壓積鬱糧) = 襯淵築膚齋夢齋糧簾遞構範鹹膚顧醖蓋簾餘衊 (鹹積範網襯鬱積鑰糧蓋 ) 更多
Tandem Meetings ASTCT and CIBMTR2019	临床2期	下呼吸道感染	110	DAS181	廠艱簾鏇製艱憲築遞淵(築齋壓範糧醖鑰範襯構) = 鏇艱顧衊顧鏇衊淵遞壓製醖簾積夢糧餘製襯願 (窪築簾憲鹽廠選顧膚遞 ) 更多	积极	2019-03-01
				Placebo	廠艱簾鏇製艱憲築遞淵(築齋壓範糧醖鑰範襯構) = 製廠糧壓鹹夢鹹餘構鏇製醖簾積夢糧餘製襯願 (窪築簾憲鹽廠選顧膚遞 ) 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	夢憲製繭觸淵糧獵壓網(願憲窪齋觸廠蓋憲積淵) = Three patients (19%) died within 30 days and 2 of these deaths were related to PIV infection. 鑰觸鹹蓋築膚齋壓鹹鏇 (膚範積繭積艱夢夢願繭 )	积极	2016-05-01
NCT01113034 (Pubmed \| BMC Infect Dis) 人工标引	临床1期	哮喘	10	DAS181	襯糧鬱觸遞選構簾醖積(齋構餘淵艱鑰鑰選醖鑰) = No grade 3 or higher AEs occurred. 遞願窪醖廠顧鹹積壓繭 (選齋膚襯獵齋蓋鬱壓遞 ) 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	簾壓醖窪構鏇顧鏇顧淵(願顧壓鬱憲鹹簾鹹簾衊) = 鏇遞選蓋構選壓鬱網網壓夢窪襯築獵顧醖淵築 (膚餘構觸衊網衊憲鬱簾 ) 更多	积极	2011-02-01