Phase 2b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of IV VIS410 in Addition to Oseltamivir Compared With Oseltamivir Alone in Hospitalized Adults With Influenza A Infection Requiring Oxygen Support

This study is to compare the efficacy and safety of VIS410 in combination with oseltamivir vs oseltamivir alone in severely ill subjects with influenza A infection requiring oxygen support.

开始日期2018-01-03

申办/合作机构

Visterra, Inc.

EUCTR2016-004009-15-EE / Not yet recruiting临床2期

Phase 2b, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of Intravenous VIS410 in Addition to Oseltamivir (Tamiflu®) Compared With Oseltamivir Alone in Hospitalized Adults With Influenza A Infection Requiring Oxygen Support

开始日期2017-09-26

申办/合作机构

Visterra, Inc.

NCT02989194 / Completed临床2期

A Phase 2a Double-blind, Placebo-controlled Study to Assess the Safety and Tolerability of a Single Intravenous Dose of an Investigational Monoclonal Antibody With Code Name VIS410 in Subjects With Uncomplicated Influenza A Infection

This is a Phase 2a randomized, double-blind, placebo-controlled study designed to assess the safety and tolerability of an investigational monoclonal antibody, VIS410, in subjects with uncomplicated influenza.

开始日期2017-01-06

申办/合作机构

Visterra, Inc.

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100 项与 VIS-410 相关的临床结果

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100 项与 VIS-410 相关的转化医学

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100 项与 VIS-410 相关的专利（医药）

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项与 VIS-410 相关的文献（医药）

2020-12-01·Antiviral Research2区 · 医学

Clinical and virological responses to a broad-spectrum human monoclonal antibody in an influenza virus challenge study

2区 · 医学

Article

作者: Szretter, Kristy J ; Shriver, Zachary ; Bedard, Sylvain ; Sloan, Susan E ; Oldach, David ; Sundaresh, Bharathi ; Narayan, Kristin M ; Skurnik, David ; Trevejo, José M ; Smith, Patrick F

Influenza A infections cause significant seasonal morbidity and mortality as well as periodic pandemic infections. Currently, no approved therapies exist for patients hospitalized with influenza. The efficacy of VIS410, a broadly neutralizing human immunoglobulin IgG1 monoclonal antibody engineered to bind to the stem region of group 1 and 2 influenza A hemagglutinins, was explored in experimental human influenza infection. Healthy volunteers were inoculated with influenza A/California/07/2009 (H1N1) and received a single dose of VIS410 or placebo 24 h later. Subjects were monitored for symptoms, viral shedding, and safety, including cytokine measurements. The primary efficacy endpoint was the area under the curve (AUC) of viral load (VL) in the VIS410 group versus placebo. VIS410 treatment was associated with a 76% reduction in median VL AUC as measured by qRT-PCR (p = 0.024). Similar VIS410 antiviral activity was observed by virus culture, with a 91% reduction in median VL AUC by TCID₅₀ (p = 0.019) compared to placebo-treated volunteers. Influenza symptoms were generally mild or moderate, with a trend toward faster resolution in VIS410-treated subjects. Treatment with VIS410 was generally safe, with an increase in gastrointestinal events that were largely mitigated by pre-treatment with oral diphenhydramine (50 mg) in combination with 600 mg of ibuprofen. Transient elevation of specific cytokines (IL-8 and TNFα) were associated with gastrointestinal adverse events. Treatment with VIS410 did not interfere with the endogenous immune response to influenza A. These data indicate that VIS410 may provide therapeutic benefit in influenza A infection. TRIAL REGISTRATION: ClinicaTtrials.gov Identification NCT02468115; https://clinicaltrials.gov/ct2/show/NCT02468115?term=NCT02468115&rank=1).

2019-07-01·Antiviral Research2区 · 医学

Advances in respiratory virus therapeutics – A meeting report from the 6th isirv Antiviral Group conference

2区 · 医学

Review

作者: Sims, Amy C ; Krafft, Amy ; Beigel, John H ; Adams, Peter L ; El-Kamary, Samer S ; Ince, William L ; Nam, Hannah H

The International Society for Influenza and other Respiratory Virus Diseases held its 6th Antiviral Group (isirv-AVG) conference in Rockville, Maryland, November 13-15, 2018. The three-day program was focused on therapeutics towards seasonal and pandemic influenza, respiratory syncytial virus, coronaviruses including MERS-CoV and SARS-CoV, human rhinovirus, and other respiratory viruses. Updates were presented on several influenza antivirals including baloxavir, CC-42344, VIS410, immunoglobulin, immune plasma, MHAA4549A, pimodivir (JNJ-63623872), umifenovir, and HA minibinders; RSV antivirals including presatovir (GS-5806), ziresovir (AK0529), lumicitabine (ALS-008176), JNJ-53718678, JNJ-64417184, and EDP-938; broad spectrum antivirals such as favipiravir, VH244, remdesivir, and EIDD-1931/EIDD-2801; and host directed strategies including nitazoxanide, eritoran, and diltiazem. Other topics included considerations of novel endpoints such as ordinal scales and patient reported outcomes (PRO), and study design issues, and other regulatory considerations for antiviral drug development. The aim of this report is to provide a summary of the presentations given at this meeting.

2019-02-01·EBioMedicine1区 · 医学

Safety and efficacy of monoclonal antibody VIS410 in adults with uncomplicated influenza A infection: Results from a randomized, double-blind, phase-2, placebo-controlled study

1区 · 医学

ArticleOA

作者: Narayan, Kristin ; Trevejo, Jose ; Hay, Catherine A ; Sloan, Susan ; Hershberger, Ellie ; Jeeninga, Rienk ; Smith, Patrick ; Smits, Saskia ; Engler, Frank ; Shriver, Zach ; Oldach, David

BACKGROUNDVIS410, a broadly neutralizing monoclonal antibody that binds the hemagglutinin stem of influenza A viruses, was safe and efficacious in a human H1N1 virus challenge study. This study evaluated the safety and tolerability of VIS410 in non-hospitalized adult patients with uncomplicated influenza A.METHODSPatients 18 to 65 years of age with symptom onset within 72 h were randomized 1:1:1 to receive a single intravenous infusion of VIS410 4000 mg, 2000 mg, or placebo. Neuraminidase inhibitor therapy was prohibited. Treatment-emergent adverse events (TEAEs) were evaluated up to 100 days post-infusion. Influenza symptoms were assessed daily for 10 days using the FLU-PRO tool. Nasopharyngeal virus shedding was assessed by quantitative reverse-transcription PCR (qRT-PCR) and viral culture through Day 7.FINDINGSOf the 150 patients randomized, 148 received study drug, and 138 were confirmed influenza A positive. Median age was 42 years; median time from symptom onset to treatment was 42 h; 93% had influenza A subtype H3N2.SAFETYTEAEs, most commonly diarrhea of mild severity, were dose-related, occurring in 55%, 35%, and 24% of the 4000 mg, 2000 mg, and placebo patients, respectively. Two serious adverse events occurred, both in placebo patients.SYMPTOM ANALYSESBaseline FLU-PRO symptom scores were balanced among groups. Mean scores were lower by Days 3 and 4 in the pooled VIS410 treatment group versus placebo (p < 0.023), with a tendency toward faster resolution by Kaplan-Meier analysis.VIROLOGY ANALYSESVIS410 was associated with reduced median nasopharyngeal viral load TCID₅₀ AUC_Day7 (days × log₁₀ TCID₅₀/mL) (3.66 pooled VIS410 vs 4.78 placebo, p = 0.08) and in the subset of patients with baseline hemagglutination inhibition (HAI) titer ≤40 (overall, 74% of patients) was significantly reduced vs placebo (4.218 pooled VIS410 vs 6.152 placebo, p = 0.009). Kaplan-Meier estimated time to resolution of viral shedding was reduced (1.9 vs 3.6 days, p = 0.03) in VIS410 treated patients. There was a trend toward greater proportion of culture-negative patients by Day 3 (66.7% vs 51.1%, p = 0.11); when this analysis was limited to the subset of patients with positive baseline cultures, this difference became more pronounced (63.2% vs 42.5%, p = 0.053). No differences were observed in nasopharyngeal influenza qRT-PCR profiles, which represent both live and neutralized virus.INTERPRETATIONVIS410 was safe and well tolerated in adults with uncomplicated influenza A, with favorable effects on symptom resolution and virus replication.TRIAL REGISTRATIONClinical Trials: NCT02989194.FUNDINGThis project was funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201500018C.

项与 VIS-410 相关的新闻（医药）

2023-03-08

·药闻康策

甲流之下，奥司他韦背后的药企

点击上方一键预约最新最热的医药健康新闻政策随着甲流来势汹汹，奥司他韦又火出圈，一度登上热搜。据了解，近一周来，天猫买药平台显示，搜索“奥司他韦”搜索用户数周环比上升了200%，其中奥司他韦儿童颗粒需求尤为旺盛，百度指数同样显示，近7天，“奥司他韦”和“甲流”这两个名词搜索量显著上升，整体日均值近万次，“甲流”这一关键词整体环比增长超4000%。奥司他韦背后的药企“卖断货”这个词特别亮眼，药企们自然得铆足干劲把“断层”补上。药品的充足储备跟大众健康息息相关，因此，奥司他韦背后的药企也因甲流的热度而备受关注。据药智数据统计，目前单奥司他韦申报厂家数高达71家，主要为胶囊、干混悬液、颗粒等剂型。除了原研药外，截至2月28日，通过一致性评价的厂家数34家，其中胶囊27家，干混悬剂7家。在药监局官网，奥司他韦已经获批的同类产品已有30款，涉及的药企有齐鲁制药、广东东阳光药业、四川科伦、南京海纳制药、华海药业等。如今奥司他韦虽然专利保护早就不再，市面上光是进入集采的仿制药就有10家，不乏石药、华海、齐鲁、科伦等国内一线化学药制剂大厂，然而东阳光药的市场地位依然难以撼动。光靠集采的那点量，制药大厂们基本都无心恋战。第七批集采约定的75mg奥司他韦胶囊共需1446万粒，即使按集采最高价、江苏诺泰奥塞诺公司报出的每一粒2.7元计算，这点采购量按比例分给10家药企，每家也就分到两三百万元的采购额。这些药企很难为了这点需求，贸然多筹备生产原料，去和东阳光药直接硬碰硬。种种原因叠加，导致奥司他韦虽已进入了国家集采，但供货主力依然只有东阳光药一家。过去十几年，东阳光药靠着奥司他韦这个品种名利双收。不过疫情三年，东阳光药也受损严重。2019年，东阳光药的奥司他韦颗粒、胶囊两个品种年销售加起来超过59亿元，占公司总收入的95%；但到了2021年，两个品种加起来也只有5.5亿元的销售额。东阳光药的业绩也随之剧烈波动。弯道超车，AI超声商业化进程提速在抗流感药物赛道，除了入局奥司他韦的药企们竞争激烈，其他品类的抗流感药物市场也扩增迅猛，布局的药企也不在少数，流感赛道竞争愈演愈烈。尽管Caption Health凭借FDA的认证率先做起了营收，但国内AI超声企业并未在商业化上落后太多距离。可以看到，除已经上市的几款抗流感药物外，众生药业研发的ZSP1273是国内首个完成II期临床试验的治疗甲型流感的小分子RNA聚合酶抑制剂，目前已经临床III期阶段；杨森制药的JNJ-5806是处于临床II期；Visterra的VIS410处于临床II期等。流感病毒是有周期的，每年都会爆发，每年也都会被压下来。面对流感病毒，我们早已认识到流感和其他所有的传染病一样。（来源:医药智投）药闻康策新媒体矩阵微信公众号点击下方一键关注【免责声明】1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。欢迎转发分享、点赞、点在看

一致性评价带量采购

100 项与 VIS-410 相关的药物交易

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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
甲型流感病毒感染	临床2期	比利时	Visterra, Inc.	2015-05-01

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临床结果

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分期

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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


NCT03040141 (CTgov)	临床2期	甲型流感病毒感染	89	High dose of VIS410 (VIS410 High Dose)	襯築網顧壓鑰鹽餘鏇鏇(選壓鏇鏇製鏇範築網餘): Odds Ratio (OR) = 1.1 (95% CI, 0.40 ~ 3.25), P-Value = 0.814 更多	-	2022-12-28
				Low dose of VIS410 (VIS410 Low Dose)
NCT02989194 (CTgov)	临床2期	甲型流感病毒感染	150	VIS410 high dose (VIS410 High Dose)	齋鏇觸簾鏇簾鹽範醖積(簾糧憲糧鏇糧窪艱艱窪) = 範艱襯鬱鹹顧衊鏇範簾鹽蓋夢齋壓壓鑰艱觸獵 (齋壓構蓋遞顧繭衊鑰鹹, 廠顧淵積鏇壓鏇構顧夢 ~ 繭醖齋製顧餘遞餘夢構) 更多	-	2022-08-15
				VIS410 low dose (VIS410 Low Dose)	齋鏇觸簾鏇簾鹽範醖積(簾糧憲糧鏇糧窪艱艱窪) = 醖齋憲觸顧糧積艱憲蓋鹽蓋夢齋壓壓鑰艱觸獵 (齋壓構蓋遞顧繭衊鑰鹹, 襯蓋艱鹽積淵選遞觸糧 ~ 積繭製憲繭糧餘蓋糧糧) 更多
NCT02468115 (Pubmed \| Antiviral Res) 人工标引	临床2期	流感病毒感染	-	VIS410	(艱壓蓋廠簾壓遞醖積鑰) = 蓋壓選觸醖觸壓簾醖構積餘餘獵廠糧築淵繭鹹 (鑰醖顧衊築淵鹽範鬱鏇 ) 更多	积极	2020-12-01
				Placebo	-
NCT02045472 (Pubmed \| EBioMedicine) 人工标引	临床1期	甲型流感病毒感染	41	VIS410	(構齋製餘齋夢積淵憲鏇) = 簾範觸獵齋獵襯觸蓋醖築憲繭鹽獵齋餘餘醖襯 (顧鏇淵製鑰願夢鑰齋壓 ) 更多	积极	2016-02-26
				Placebo	(構齋製餘齋夢積淵憲鏇) = 鹹夢鹽衊鏇簾鹹廠顧淵築憲繭鹽獵齋餘餘醖襯 (顧鏇淵製鑰願夢鑰齋壓 ) 更多