Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)

This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design.
Cohort A: Participants will be randomized to receive either a placebo or vilobelimab.
This record describes the default procedures and analyses for Cohort A. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.

开始日期2025-06-21

申办/合作机构

PPD Development LP

[+4]

NCT06703073

/ Recruiting临床2期

Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)

This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design. Participants will be randomized to receive either a placebo or one of the active treatments.
This record describes the default procedures and analyses for all cohorts. Each specific cohort may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in the corresponding intervention-specific records on clinicaltrials.gov listed below in the detailed description.

开始日期2025-06-10

申办/合作机构

PPD Development LP

[+4]

NCT05964413

/ Terminated临床3期

A Randomized, Double-blind, Placebo-controlled, Multicenter, Adaptive Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in the Treatment of Ulcerative Pyoderma Gangrenosum

A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to investigate efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum

开始日期2023-11-01

申办/合作机构

InflaRx GmbH

100 项与韦洛利单抗相关的临床结果

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100 项与韦洛利单抗相关的转化医学

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100 项与韦洛利单抗相关的专利（医药）

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项与韦洛利单抗相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

A network meta-analysis study of monotherapies for hidradenitis suppurativa: analyses of the current evidence base

Review

作者: Economopoulos, Vasiliki ; Magalhaes, Renata ; Bamimore, Mary A. ; Talukder, Mesbah ; Piguet, Vincent ; Gupta, Aditya K.

BACKGROUND:

The number of monotherapies for hidradenitis suppurativa (HS) has expanded. However, the efficacy of active comparators has not been determined in head-to-head trials.

AIMS:

We conducted an NMA to determine the relative efficacy and safety of monotherapies for HS.

METHODS:

The literature was systematically reviewed to obtain data from trials that (1) were published in English, (2) investigated a systemically administered monotherapy with an immunomodulatory agent (3) randomized, and (4) quantified efficacy, at 16 weeks, insofar as the Hidradenitis Suppurativa Clinical Response 50 (HiSCR-50), Dermatology Life Quality Index (DLQI) and Numeric Rating Scale 30 (NRS30). For safety, we analyzed the occurrence of treatment-emergent adverse events (TEAEs). For sensitivity analyses, we conducted network meta-regressions adjusted for age and sex.

RESULTS:

We determined the efficacy of numerous regimens including those approved by the United States FDA; for instance, the FDA-approved 'bimekizumab 320 mg every 2 weeks' was more efficacious than 'IFX-1 800 mg every 2 weeks' (odd ratio = 1.99, 95% credible interval: 1.09,3.87, p < 0.05) in terms of HiSCR-50. Sensitivity analyses showed that the main analyses were robust. Overall, risk of bias across studies was low.

CONCLUSIONS:

The current NMA provides comparative evidence on systematic immunomodulatory HS monotherapies from the most up-to-date trial evidence.

2025-04-29·AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY

An evaluation of vilobelimab (anti-C5a) as a cost-effective option to treat severely ill mechanically ventilated patients with COVID-19

Article

作者: Oderda, Gary ; Biskupiak, Joseph ; Seheult, Roger ; Brixner, Diana ; Malone, Daniel C

Abstract:

Purpose:

COVID-19 patients in intensive care units (ICUs) requiring invasive mechanical ventilation (IMV) have few available treatment options. PANAMO, a multicenter, double-blind, randomized, placebo-controlled phase 3 study of vilobelimab, which blocks the inflammatory process caused by complement component 5a, demonstrated a significant mortality benefit at 28 and 60 days in these patients. A cost-effectiveness analysis was conducted to assess the incremental cost per quality-adjusted life-year (QALY).

Methods:

A Markov model was used to estimate QALYs and the incremental cost-effectiveness ratio (ICER) of vilobelimab plus standard of care (SOC) versus SOC alone. The model simulated progression from severe COVID-19 to survival or death over a lifetime horizon. Outcomes data (COVID-19 all-cause mortality and renal replacement therapy) were incorporated from the PANAMO trial. COVID-19 mortality estimates were based on Centers for Disease Control and Prevention age-specific survival data. Utility values and hospital costs came from the literature. Vilobelimab cost was obtained from RED BOOK Online.

Results:

For COVID-19 ICU patients, total costs of care were $103,414 (SOC) and $132,247 (SOC plus vilobelimab), respectively, resulting in an incremental cost of $28,833. SOC provided 6.70 QALYs versus 7.99 QALYs for vilobelimab, an additional 1.29 QALYs. The ICER for vilobelimab plus SOC versus SOC alone was $22,287/QALY. Probabilistic sensitivity analysis demonstrated the robustness of the cost-effectiveness result as vilobelimab plus SOC was favored at a willingness-to-pay threshold of $50,000 in over 81% of iterations.

Conclusion:

Vilobelimab provides a cost-effective option to treat ICU patients with severe COVID-19 receiving IMV compared to SOC, at well below the commonly accepted $50,000 US willingness-to-pay threshold.

2025-04-01·BMJ Open Respiratory Research

Regional comparison of efficacy and safety for vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients

Article

作者: Rückinger, Simon ; Zerbib, Robert ; Riedemann, Niels C ; Vlaar, Alexander P ; van de Beek, Diederik ; Thielert, Claus ; Brouwer, Matthijs C ; Lim, Endry H T ; de Bruin, Sanne ; Burnett, Bruce P ; Guo, Renfeng ; Chong, Camilla

Background:

Vilobelimab, a first in class C5a-specific monoclonal antibody, improved 28-day and 60-day mortality in intubated COVID-19 patients in PANAMO, a phase 3 randomised, double-blind, placebo-controlled multicentre study. All-cause mortality was pre-specified to be analysed pooling by region (western Europe, South America, South Africa/Russia).

Methods:

Critically ill, invasively mechanically ventilated COVID-19 patients were randomised in a 1:1 ratio within 48 hours of intubation to receive vilobelimab treatment (six, 800 mg intravenous infusions) or placebo on top of standard of care. We analysed the efficacy and safety of vilobelimab based on prespecified geographic regions.

Results:

368 patients were randomised and analysed: 177 in the vilobelimab group and 191 in the placebo group. In western Europe (n=209), 28-day all-cause mortality was significantly lower in the vilobelimab group (21%) compared with placebo (37%) (HR 0.51 (95% CI: 0.30, 0.87), p=0.014). In South America (n=126), mortality was similar between groups (40% vs 37%; HR 0.94 (95% CI: 0.53, 1.67), p=0.83). In South Africa/Russia (n=33), mortality was 69% in the vilobelimab group and 87% in the placebo group (HR 0.62 (95% CI: 0.28, 1.38), p=0.25). Within the Brazilian subpopulation (n=74), a significant age imbalance between the vilobelimab and placebo group was detected (median 53.5 years in the vilobelimab group vs 44.5 years in the placebo group). Occurrence of treatment-emergent adverse events between regions was similar.

Conclusion:

The most apparent 28-day all-cause mortality benefit for vilobelimab was in western Europe. Age imbalance between treatment groups in Brazil may have resulted in a lower efficacy signal for vilobelimab in South America compared with other regions. Overall, vilobelimab demonstrated a favourable safety profile and reduced mortality in critically ill, intubated COVID-19 patients, with regional variations influencing outcomes.

122

项与韦洛利单抗相关的新闻（医药）

2025-07-31

·GlobeNewswire-Health Care

InflaRx to Report Second Quarter 2025 Results on August 7, 2025

JENA, Germany, July 31, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that the Company will report its second quarter 2025 financial and operating results on August 7, 2025, before the market opens. No conference call is planned. About InflaRx InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5a receptor technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx has developed vilobelimab, a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies. InflaRx is also developing INF904, an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de. InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx). Contacts: InflaRx N.V.MC Services AGJan Medina, CFAVice President, Head of Investor RelationsEmail: IR@inflarx.deKatja Arnold, Laurie Doyle, Dr. Regina LutzEmail: inflarx@mc-services.eu Europe: +49 89-210 2280U.S.: +1-339-832-0752 FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses, current expectations and the risks, uncertainties and other factors described under the headings, “Risk factors” and “Cautionary statement regarding forward looking statements”, in our periodic filings with the SEC. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

财报引进/卖出

2025-06-04

·贝壳社

FDA失速？生物药审批“欧洲优先”背后的监管困局

作者：布布在全球新药审批格局中，美国长久以来被视为全球创新药物的“首发地”。然而，根据Pink Sheet对2024–2025年药品审批数据的深度分析揭示出一种值得关注的新趋势：在22款先获欧盟（EU）批准的新产品中，绝大多数为生物制剂，而非传统的小分子药物。这一现象或许并非偶然，而是源自美国在合同生产和质量审评上的系统性挑战。01FDA仍然领先，但欧盟“抢跑”增多Pink Sheet的最新分析指出，截至2025年5月20日，FDA已批准17款新药和生物制剂，欧盟和美国监管机构总计批准了37款产品。其中美国仍在整体数量上保持首批优势。然而，这一优势在生物制剂领域出现了“局部滑坡”。2024–2025年间，在欧盟率先获批的22款产品中，绝大多数为疫苗、抗体、细胞疗法和基因疗法等生物制品（表1）。表 1. 2024年至2025年5月20日欧盟领先美国上市新药一览表如果我们回顾2024年全年批准的新药构成，可以看出美国FDA在小分子药物领域仍保持强势地位。2024年FDA共批准了61款创新药物，而欧盟为37款，其中大部分欧盟获批产品最终也在美国获得上市许可。然而，在某些结构复杂、制造要求高的生物制剂领域，这一优势正在减弱。以典型案例来看，Novavax的COVID-19疫苗Nuvaxovid早在2021年底就已获得欧盟批准，美国直到2025年5月才完成正式批准，时间滞后超过40个月；medac/Medexus的Grafapex（treosulfan）在欧盟于2019年获批，美国则在2025年初才通过，滞后长达67个月。类似的还有Atara的Ebvallo（tabelecleucel），其在2022年即获欧盟上市许可，至2025年仍未获得FDA批准，反而收到CRL，主要因制造流程未满足FDA对一致性和GMP的高标准要求。在2025年欧盟先批的新药中，有3款用于新冠防治，包括Arcturus的Kostaive（首个自扩增 mRNA疫苗）、阿斯利康的Kavigale（长效抗体），以及InflaRx的Gohibic（ARDS治疗用抗体）。虽然这些产品在欧盟获得上市，但在美国则未能获得常规BLA批准，甚至部分尚未递交上市申请，反映出制药企业对美国监管节奏及市场预期的重新权衡。进一步观察数据还发现：除了极端的时间滞后案例，诸如PTC的Kebilidi（延迟28.9个月）、Orchard的Lenmeldy（延迟39个月）、Akebia的Vafseo（延迟11.1个月）等产品，也呈现出“欧先美后”的审批路径。这种时间差的背后，除了临床数据与适应症设定外，核心在于FDA对制造数据、生产体系一致性和第三方代工厂的深度审查，这些都大幅拉长了美国市场的准入周期。总体而言，美国FDA在新分子实体方面仍占据审批数量和速度的双重优势。但欧盟在生物制剂审批方面的“抢先”现象愈发频繁，且集中于制造复杂、CMC挑战高的产品类别。这种结构性变化表明，美国的全球首发地位虽未动摇，但已开始面临来自欧盟在特定技术领域上的有效挑战。02生物制剂审批的软肋：制造质量与第三方生产FDA对生物制剂的质量审评严苛，尤其在生产可比性（comparability）、验证数据完整性以及第三方合同生产（CDMO）设施的合规性方面，要求尤为苛刻。据统计，2024–2025年欧盟先批的22款药品中，有8款在FDA因制造相关问题收到完整回应信（CRL），其中5例直接关联第三方生产设施的质量问题。来自礼来（Lilly）的lebrikizumab（Ebglyss）便是典型案例：FDA要求其聘请第三方重新评估生产数据的可靠性，而欧洲则在早于FDA近一年时间内给予上市许可。又如Atara的复发或难治性EB病毒阳性移植后淋巴增殖性疾病细胞疗法Ebvallo（tabelecleucel）在欧洲通过“特殊情况”通道获批后迅速上市，而FDA因GMP问题和第三方厂商不合规发出CRL，并一度对临床试验实施临床暂停。此外，FDA对于海外生产数据的采信门槛亦显著提高。例如，PTC的基因疗法Kebilidi因临床研究样品与商业化产品工艺不一致被要求补充新的临床数据，导致美国上市时间晚于欧盟两年有余。03FDA对毒性与安全性数据关注严格除了生产环节，美国FDA在药物的安全性评估与数据完整性方面也保持着高度谨慎的态度，常常比其他监管机构设置更高的准入门槛。这种审慎策略虽然有助于保障患者利益，但在全球同步申报的背景下，也往往造成美方审批节奏的明显滞后。某些药物即便在日本或欧盟等海外市场已有多年上市经验和临床安全记录，仍可能因潜在的器官毒性问题而遭遇FDA的严格质疑。例如，Akebia Therapeutics 开发的口服HIF-PHI药物 Vafseo（vadadustat）早在2020年即在日本获批用于肾性贫血治疗，并在2023年获得欧盟上市许可。然而，FDA在审评过程中高度关注其早期临床试验中出现的肝脏不良反应，认为现有数据尚不足以排除肝毒性风险。在经历一次完整回应信（CRL）后，企业不得不收窄适应症范围，仅限于透析依赖型患者，并配套长期肝功能监测方案，最终才于2024年在美获批。这一过程反映出，即便拥有海外上市经验，美国监管方依旧对潜在毒性保留更高警惕性，特别是在作用机制新颖或靶点复杂的药物中更为常见。对于依赖复杂检测指标作为关键终点的产品，FDA尤其强调原始数据的可追溯性与逻辑一致性。以treosulfan（商品名为Grafapex）为例，该药在欧盟早于2019年便已获批用于造血干细胞移植前的预处理，但其美国新药申请于2020年提交后，连续两次遭遇FDA完整回应信（CRL）。FDA指出，该药关键终点为“无事件生存期（EFS）”，但企业最初提交的数据包中缺少全部患者的骨髓和血细胞检查原始记录，无法支撑终点判定。这一问题使得监管机构在2021年CRL中明确表示“无法确认EFS结果的可信度”，并在随后的补充回复中继续批评数据缺失与逻辑混乱。最终，企业在2024年提交了系统化的溯源审计材料，覆盖所有受试者的骨髓报告与原始数据后才获得FDA认可。这一审批过程充分说明，FDA在面对此类数据驱动型药物时，其标准不仅仅是“有效”或“安全”，而是“数据是否完整”、“分析是否透明”、“原始记录是否经得起溯源”。这些标准常常远超其他地区的监管机构，从而导致明显的审批周期延长。这也凸显出FDA在面对临床关键指标时，极度重视数据基础是否扎实、可重复。04制度因素也在“带节奏”FDA加速批准机制本意是为了让严重疾病领域的潜力药物更快上市，早期释放治疗价值。但自2022年《食品药品综合改革法案》（FDORA）生效后，该机制增加了一项关键性新要求：药品在获得加速批准时就开始进行验证性研究。这项变革虽有助于提升加速批准的可信度，却也在客观上延缓了部分创新疗法的上市节奏，尤其影响了那些尚未启动确证性试验或临床路径复杂的产品。再生元开发的CD20×CD3双特异性抗体odronextamab（商品名：Ordspono）便面临这一制度掣肘。该药在欧盟已于2024年8月获得批准，用于治疗两种B细胞非霍奇金淋巴瘤：复发或难治性的滤泡性淋巴瘤（FL）和弥漫性大B细胞淋巴瘤（DLBCL）。而在美国，尽管再生元也同步递交了BLA申请，但FDA于2024年3月向其发出完整回应信（CRL），指出公司所提交的III期OLYMPIA临床试验尚处于剂量探索阶段，未能满足FDORA法规下“确证性试验正在进行”的要求。因此，再生元不得不分拆提交，将BLA缩减为只覆盖FL适应症，而DLBCL部分则延后处理。这类制度性的门槛，不仅延迟了多发适应症同步推进的可能，也对企业的申报策略、临床节奏与商业部署带来更高的不确定性。05新药首发地的多极化趋势已成现实值得注意的是，在FDA持续应对制造质量、毒性控制、制度改革等多重挑战的同时，全球“首批上市地”的格局本身也在悄然发生变化。2024年FDA新批准药物中，越来越多的全球首次批准地已不在美国，而是来自亚洲、欧洲或加拿大（表2）。表 2. 非美国首次上市的FDA 2024年批准新药例如，2024年FDA批准的新药中，包括百济神州的Tevimbra、Akebia的Vafseo、阿斯利康的Voydeya、安斯泰来的Vyloy等多个产品，均早在中国、日本或欧盟市场获批。其中一些药品在FDA批准时，已在海外市场销售多年，甚至首次上市时间可追溯至十多年前。这不仅反映出这些国家监管机构能力的提升，也显示出全球药企对不同市场审批效率和路径确定性的重新评估与布局。对FDA而言，这种趋势可能进一步加剧其在生物制剂领域的“时间劣势”感知。从全球新药审批格局来看，“美国首批”已不再是唯一常态，首发地的多极化趋势正在成为行业新现实。06结语回顾2024–2025年欧盟“抢先”批准的生物制剂清单，人们看到的不只是个别产品命运的转折，更是一种全球监管格局的悄然重塑。在FDA仍牢牢掌握大多数全球首批审批主导权的同时，那些复杂度高、路径前沿、生产挑战大的创新疗法，越来越倾向于先在欧盟完成上市首发。这并非意味着FDA正在“放慢脚步”，而是反映出其对制造一致性、毒性控制、数据可追溯性和制度规范的多重叠加标准，正成为全球最严的准入门槛之一。随着FDORA等法规的强化实施，“快速上市”的定义在美国变得更为谨慎和多条件绑定。与此同时，EMA的策略则体现出更大程度的灵活性：在制造问题尚可控、数据充分支持疗效的基础上，以有条件批准、例外路径等方式为高需求治疗选项开通通道。这种对风险与应急之间的动态平衡，正成为欧盟在新药首发竞争中频频“超车”的关键变量。对全球药企而言，未来的新药首发路径不再只是技术成熟度与市场潜力的博弈，更是对不同监管体系中“可控性”与“可预测性”的评估。在这一新格局下，制造体系的稳健程度、注册策略的全球统筹能力，以及企业自身的临床开发节奏掌控，将共同决定创新药物能否在全球多个市场高效落地。首发之争的焦点，已从审批速度的简单比较，转向了对监管适应能力的全链条挑战。往期推荐1医健企业前沿动态2医健行业BD/出海/投融资洞察___*声明：本文仅为作者观点，不构成任何投资建议，且非治疗方案推荐Ref.Silverman, B. EU Authorization Before US? Biologics Manufacturing Is Likely To Blame. Pink Sheet. 26. 05. 2025.关于贝壳社贝壳社是国内领先的医健创新创业服务平台，构建了"产业空间+创业教育+投资孵化+资本运作"四位一体服务体系，为医健领域创业企业提供全周期赋能。通过深度挖掘高成长项目、精准匹配产业资源及全球化生态网络，覆盖企业从孵化培育到加速发展的全链路，重点提供包括空间落地、创业培训、资本运作及跨境资源链接服务。贝壳社以加速科学技术成果转化与产业升级为目标，致力于成为医健领域的孵化器、加速器、连接器。

疫苗信使RNA细胞疗法优先审批上市批准

2025-05-28

·FiercePharma

InflaRx drops rare skin disease study for COVID med vilobelimab after futility signal

Vilobelimab is a monoclonal antibody designed to block the immune complement factor C5a, which has been implicated in many different inflammatory diseases. After a poor showing of its COVID med vilobelimab in a rare skin disorder trial, German drugmaker InflaRx is going back to the drawing board.The independent data monitoring committee assessing a phase 3 trial of vilobelimab in pyoderma gangrenosum (PG) has urged InflaRx to stop the study early for futility. The committee made the call after analyzing data on the first 30 patients enrolled in the study, InflaRx said in a Wednesday press release. InflaRx noted that it remains blinded to the study results.Given the trial’s outcome, InflaRx plans to stop development of vilobelimab in PG, though the drug will remain available in the U.S. under emergency use authorization to treat critically ill COVID patients, the company clarified.Vilobelimab—which goes by the commercial moniker Gohibic in its authorized COVID indication—is a monoclonal antibody designed to block the immune complement factor C5a, which has been implicated in many different inflammatory diseases.PG is a rare skin condition that causes large, painful sores to form on the skin, most often on the legs. While the exact cause of PG remains elusive, it is believed to be an immune disorder, the Mayo Clinic notes.“While the outcome is not what we had hoped it would be, InflaRx remains committed to its goal of developing new therapies for underserved patients with chronic immune-dermatological conditions,” Niels Riedemann, InflaRx’s chief executive, said in a statement. The company now aims to focus its resources on its oral small molecule candidate INF904—also a C5a inhibitor—which is expected to deliver phase 2a readouts in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) this summer, InflaRx said.Meanwhile, the trial winddown may herald the start of a broader cost-saving effort at the company, InflaRx warned. The drugmaker said it is considering a potential “redirection of resources” to help extend its cash runway.The FDA awarded emergency use authorization to vilobelimab, A.K.A. Gohibic, in April 2023, though the data that supported that sign-off were less-than-ideal.In a randomized late-stage trial, Gohibic failed to deliver statistically significant results on the study’s primary endpoint of curbing the risk of death in the sickest COVID patients. That said, a separate predefined analysis and two post hoc analyses painted the drug in a better light, showing an improvement that was statistically significant. In the U.S., the antibody is specifically cleared for use in hospitalized patients within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). InflaRx noted that it will carry on with a BARDA-funded phase 2 study of Gohibic as a potential treatment for acute respiratory distress syndrome (ARDS).Gohibic has also won marketing authorization under exceptional circumstances in the European Union—a distinction not entirely dissimilar to an FDA emergency use nod—to treat adults with SARS-CoV-2-induced ARDS who are on systemic corticosteroids and receiving IMV with or without ECMO.After the trial update, InflaRx’s share price was down more than 50% in Wednesday morning trading.

临床3期上市批准临床2期紧急使用授权

100 项与韦洛利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11838	-	-	DB16416

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
急性呼吸窘迫综合征	欧盟	InflaRx GmbH	2025-01-13
急性呼吸窘迫综合征	冰岛	InflaRx GmbH	2025-01-13
急性呼吸窘迫综合征	列支敦士登	InflaRx GmbH	2025-01-13
急性呼吸窘迫综合征	挪威	InflaRx GmbH	2025-01-13
新型冠状病毒感染	美国	InflaRx NV	2023-04-04

未上市

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
坏疽性脓皮病	临床3期	美国	InflaRx GmbH	2023-11-01
坏疽性脓皮病	临床3期	澳大利亚	InflaRx GmbH	2023-11-01
坏疽性脓皮病	临床3期	比利时	InflaRx GmbH	2023-11-01
坏疽性脓皮病	临床3期	法国	InflaRx GmbH	2023-11-01
坏疽性脓皮病	临床3期	德国	InflaRx GmbH	2023-11-01
坏疽性脓皮病	临床3期	匈牙利	InflaRx GmbH	2023-11-01
坏疽性脓皮病	临床3期	意大利	InflaRx GmbH	2023-11-01
坏疽性脓皮病	临床3期	波兰	InflaRx GmbH	2023-11-01
坏疽性脓皮病	临床3期	西班牙	InflaRx GmbH	2023-11-01
坏疽性脓皮病	临床3期	瑞士	InflaRx GmbH	2023-11-01

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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


NCT05964413 (Biospace) 人工标引	临床3期	坏疽性脓皮病	-	vilobelimab	餘糧襯築醖餘餘鏇艱製(醖醖繭艱蓋襯廠鏇膚壓) = InflaRx’s vilobelimab met the bar for futility in a Phase III trial for the rare skin disease pyoderma gangrenosum. 製鑰願夢壓壓淵艱壓淵 (範鬱繭衊網憲網淵窪鏇 ) 未达到	不佳	2025-05-28
ATS2025	N/A	军团杆菌病 \| 新型冠状病毒感染 \| 耐甲氧西林金黄色葡萄球菌感染 SARS-CoV-2 PCR+ \| MRSA PCR+ \| Legionella+	1	Vilobelimab 800mg	窪選製蓋鹽窪顧範鑰齋(繭繭窪糧製積觸衊窪觸) = 網範齋夢膚積廠製廠衊廠網廠鹽遞蓋餘遞鏇鹹 (鹽夢膚繭淵範艱積齋窪 ) 更多	积极	2025-05-16
PANAMO (ATS2025)	临床3期	急性呼吸窘迫综合征 SARS-CoV-2 infection	-	Vilobelimab 800mg + standard-of-care (SOC)	廠顧夢築淵窪顧鏇繭製(鬱廠衊襯襯襯壓積製壓): HR = 0.75 (95% CI, 0.48 ~ 1.16), P-Value = 0.19	积极	2025-05-16
				Placebo + standard-of-care (SOC)
NCT04812535 (CTgov)	临床2期	皮肤鳞状细胞癌	30	Vilobelimab (Arm A:)	築齋餘蓋願鹽壓鬱網糧 = 窪獵構鬱選衊鬱淵蓋糧艱顧積衊夢齋願遞製鑰 (夢夢鹹遞壓範壓顧齋遞, 齋鹽蓋膚窪廠壓顧壓淵 ~ 鑰夢窪鹽選範窪廠襯夢) 更多	-	2025-02-11
				Vilobelimab+pembrolizumab (Arm B: Regimen 1:)	範鬱憲鬱願構鹹製顧網(糧鹹範鹽齋願壓餘鬱顧) = 鹽遞憲壓淵簾觸窪鏇淵顧糧糧築衊窪窪膚膚積 (願繭獵鹹鬱構觸鹽遞艱, 廠積願襯窪憲壓鏇夢襯 ~ 憲製糧艱願窪獵選鹽醖) 更多
NCT03487276 (SHINE, GlobeNewswire) 人工标引	临床2期	化脓性汗腺炎	177	Vilobelimab 1200 mg	襯積遞醖艱觸糧醖網網(廠顧網淵鹹觸簾選簾膚) = 選醖選願餘鹽簾鹽衊壓製選鏇窪鹹鹽選餘製構 (餘構鹽選襯築簾鹹鏇艱 )	积极	2024-09-25
				Placebo	-
NCT03971643 (CTgov)	临床2期	坏疽性脓皮病	19	vilobelimab (Vilobelimab 800 mg Q2W)	憲夢簾獵夢鏇範憲築糧 = 範築蓋範壓願顧網齋鹽窪糧壓積網襯製顧夢鑰 (鹽鬱夢鑰餘簾鹹製膚獵, 艱糧窪壓衊鹽鹹壓鹹遞 ~ 願製積醖繭觸餘選獵廠) 更多	-	2023-09-14
				vilobelimab (Vilobelimab 1600 mg Q2W)	憲夢簾獵夢鏇範憲築糧 = 繭鏇鹽艱簾窪壓齋廠構窪糧壓積網襯製顧夢鑰 (鹽鬱夢鑰餘簾鹹製膚獵, 構糧願鹹艱獵衊鹽選鹹 ~ 鹽網鹹窪願醖積醖鬱膚) 更多
NCT04333420 (PANAMO, Pubmed \| Intensive Care Med Exp)	临床3期	新型冠状病毒感染	368	Vilobelimab	遞壓鑰淵壓廠網網鬱糧(淵鬱鹹選鏇繭顧製壓鹹) = 齋積網膚簾範繭製醖襯顧膚醖淵蓋餘齋獵選窪 (艱憲繭鑰繭齋遞憲衊襯 )	积极	2023-06-19
				Placebo	遞壓鑰淵壓廠網網鬱糧(淵鬱鹹選鏇繭顧製壓鹹) = 繭醖齋鑰鏇鹽範願壓獵顧膚醖淵蓋餘齋獵選窪 (艱憲繭鑰繭齋遞憲衊襯 )
NCT04333420 (PANAMO, FDA) 人工标引	临床3期	新型冠状病毒感染	368	vilobelimab+SoC	積繭範製繭範獵齋膚簾(鑰窪鬱網獵選簾積齋艱) = 窪選醖選網鏇築選願觸窪網糧蓋鏇選選繭願鹹 (獵衊壓淵餘觸網鬱簾餘 ) 更多	积极	2023-04-04
				Placebo+SoC	積繭範製繭範獵齋膚簾(鑰窪鬱網獵選簾積齋艱) = 醖遞願糧膚淵遞鹽鑰膚窪網糧蓋鏇選選繭願鹹 (獵衊壓淵餘觸網鬱簾餘 ) 更多
NCT03895801 (IXCHANGE Trial, ACR2022)	临床2期	抗中性粒细胞胞质抗体相关性血管炎追加	57	Vilobelimab + reduced-dose GC (RDGC)	簾鹹壓齋簾遞鑰遞簾夢(衊餘鏇觸願鹹窪艱衊憲) = 鹽糧糧蓋積顧壓構膚願襯選網鬱願壓壓積蓋鏇 (願膚鏇襯構壓築獵獵窪 ) 更多	积极	2022-11-12
				Standard-dose GC (SDGC)	簾鹹壓齋簾遞鑰遞簾夢(衊餘鏇觸願鹹窪艱衊憲) = 獵簾餘淵顧選繭窪構觸襯選網鬱願壓壓積蓋鏇 (願膚鏇襯構壓築獵獵窪 ) 更多
NCT04333420 (PANAMO, Literature \| Pubmed \| Lancet Respir Med) 人工标引	临床3期	新型冠状病毒感染	368	Standard of Care+Vilobelimab	範廠壓鏇餘膚淵鬱積糧(選鹹遞鹽構餘壓憲餘襯) = 製遞積餘壓蓋構觸顧糧製繭餘積衊憲顧簾襯膚 (鹽壓憲觸鏇鑰廠繭範膚, 25 ~ 39) 更多	积极	2022-09-07
				Standard of Care+Placebo	範廠壓鏇餘膚淵鬱積糧(選鹹遞鹽構餘壓憲餘襯) = 鬱鹽壓壓鹹積鏇簾鑰築製繭餘積衊憲顧簾襯膚 (鹽壓憲觸鏇鑰廠繭範膚, 35 ~ 49) 更多