A Pragmatic Adaptive Randomized, Controlled Phase II/III Multicenter Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
Latest Information Update: 14 May 2025
At a glance
- Drugs Vilobelimab (Primary) ; Anticoagulants; Baricitinib; Dexamethasone; Immunomodulators; Tocilizumab
- Indications COVID-19 pneumonia
- Focus Registrational; Therapeutic Use
- Acronyms PANAMO
- Sponsors InflaRx
Most Recent Events
- 15 Jan 2025 According to an InflaRx media release, company has announced that the European Commission (EC) has granted marketing authorization under exceptional circumstances for GOHIBIC (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome. The EU approval of GOHIBIC is supported by the previously announced results of the multicenter Phase 3 PANAMO trial. Under the terms of GOHIBIC (vilobelimab)s approval in the EC, InflaRx will provide annual update
- 15 Nov 2024 According to an InflaRx media release, company anticipates approval of vilobelimab for COVID-19 pneumonia in European Union (IV) in early 2025.
- 15 Nov 2024 According to an InflaRx media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization of GOHIBIC, under exceptional circumstances for patients with SARS-CoV-2-induced ARDS receiving systemic corticosteroids and invasive mechanical ventilation The Company expects the European Commission to adopt the positive opinion and issue a marketing authorization within 67 days.
Trial Overview
Outcome
Purpose
Phase II & Phase III: This is a pragmatic, adaptive, randomized, multicenter phase II/III study evaluating IFX-1 for the treatment of COVID-19 related severe pneumonia. The study consists of two parts: Phase II, an open-label, randomized, 2-arm phase evaluating best supportive care (BSC) + IFX-1 (Arm A) and BSC alone (Arm B); and Phase III, a double-blind, placebo-controlled, randomized phase comparing standard of care (SOC) + IFX-1 (Arm A) versus SOC + placebo-to-match (Arm B)
Comments
According to an InflaRx media release, company has announced that the European Commission (EC) has granted marketing authorization under exceptional circumstances for GOHIBIC (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome. The EU approval of GOHIBIC is supported by the previously announced results of the multicenter Phase 3 PANAMO trial.
According to an InflaRx media release, in October 2024, the Committee for Medicinal Products for Human Use (CHMP) convened to review the MAA; the regulatory process continues with discussions ongoing between the Company and the CHMP, with a CHMP opinion anticipated around the middle of November.
According to an InflaRx media release, based upon data from this trial ; the Company has submitted a Marketing Authorization Application (MAA) for the treatment of adult patients with SARS-CoV-2 induced septic ARDS receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) and that the European Medicines Agency (EMA) has validated the MAA. This means that the application is now under regulatory review by the European Committee for Medicinal Products for Human Use (CHMP) under the centralized procedure, which applies to all 27 member states of the European Union (EU).
According to an InflaRx media release, company is continuing discussions with the FDA related to the submission of a Biologics License Application (BLA) for a potential future full approval of Gohibic.
According to an InflaRx media release, an Emergency Use Authorization (EUA) has been granted by the US Food and Drug Administration (FDA) for Gohibic (vilobelimab) for treatment of coronavirus disease 19 (COVID-19) in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO). Also, Gohibic has not been approved but has been authorized for emergency use by FDA under an EUA. The data supporting the EUA were based on the previously announced results published in The Lancet Respiratory Medicine.
According to an InflaRx media release, the company has submitted a request for Emergency Use Authorization (EUA) following encouraging interactions with the US Food and Drug Administration (FDA) at a Type B meeting held this summer.
According to an InflaRx media release, vilobelimab has been granted FDA Fast Track designation to treat critically ill COVID-19 patients based on the results of this study.
According to an InflaRx media release, the company plans to submit a request for Emergency Use Authorization (EUA) following encouraging Type B meeting with US FDA. In the meeting with the FDA, the company discussed in detail the completed Phase III part of the PANAMO study in invasively mechanically ventilated, critically ill COVID-19 patients. Application for EUA planned to be submitted in Q3 2022
Primary Endpoints
Phase III: 28-day All-cause Mortality (FAS)
description: Number and percentage of deaths (all-cause) until Day 28 (FAS)
time_frame: Day 28
Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position at Day 5 (FAS)
description: Relative change (%) from baseline in Oxygenation Index (OI; partial pressure of oxygen in the arterial blood (PaO2) / fractional inspired oxygen (FiO2)) in supine position for ≥2 hours at day 5 (FAS)
time_frame: Baseline and Day 5
Other Endpoints
Phase II: All-cause 28-day Mortality (FAS)
description: Number and percentage of deaths (all-cause) until Day 28 (FAS)
time_frame: Day 28
Phase II: Early Response at Day 7 After Enrollment
description: Number of patients (%) achieving an early response at day 7 after enrollment (FAS)
time_frame: Day 7
Phase II: Late Response Until Day 28 After Enrollment
description: Number of patients (%) reaching a late response until day 28 (FAS)
time_frame: Baseline until Day 28
Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position (FAS)
description: Relative change (%) from baseline in Oxygenation Index (OI) in supine position for ≥2 hours at days 3, 7, 9, 11, and 15 (FAS)
time_frame: Baseline, Day 3, Day 7, Day 9, Day 11, Day 15
Phase III: 60-day All-cause Mortality (FAS)
description: Number and percentage of deaths (all-cause) until Day 60 (FAS)
time_frame: Day 60
Phase III: Percentage of Patients With an Improvement in the 8-point Ordinal Scale (FAS)
description: Percentage of patients with an improvement in the 8-point ordinal scale (Day 15, Day 28), the scale ranges from 0 = 'No clinical or virological evidence of infection' to 8 = 'Death' with higher scores meaning greater limitation and ventilation/organ support
time_frame: Day 15, Day 28
Phase III: Percentage of Patients Developing Acute Kidney Failure Until Day 28 (FAS)
description: Percentage of patients developing acute kidney failure (estimated glomerular filtration rate [eGFR] < 15 mL/min/1.73m², assessed by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation requiring race information) until Day 28 (FAS)
time_frame: Day 28
Phase III: Percentage of Patients Free of Any Renal Replacement Therapy Within 28 Days Upon Randomization (FAS)
description: Percentage of patients free of any renal replacement therapy (RRT) within 28 days upon randomization (FAS), number of patients free of any RRT = number of patients - number of patients with RRT initiated after randomization until Day 28
time_frame: Day 28 [1]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| COVID-19 pneumonia | treatment | severe |
Subjects
- Subject Type patients
-
Number
Planned: 430
Actual: 399
- Sex male & female
- Age Group ≥ 18 years; adult; elderly
Patient Inclusion Criteria
Phase II - At least 18 years of age or older - Clinically evident or otherwise confirmed severe pneumonia - SARS-CoV-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system)
Patient Exclusion Criteria
- Known history of progressed COPD as evidenced by use of daily maintenance treatment with long-acting bronchodilators or inhaled/oral corticosteroids for > 2 months - Patient moribund or expected to die in next 24h according to the judgment of the investigator - Known severe congestive heart failure (New York Heart Association [NYHA] Class III- IV) - Received organ or bone marrow transplantation in past 3 months - Known cardio-pulmonary mechanical resuscitation in past 14 days Phase III: Inclusion Criteria: - At least 18 years of age or older - Patient on invasive mechanical ventilation (but not more than 48h post intubation at time point of first IMP administration) - Patients with a PaO2 / FiO2 ratio of < 200 and > 60 at randomization (one representative measurement within 6h before randomization) - SARS-CoV-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system) - Intubated > 48 h at time point of first IMP administration - Expected stop of invasive ventilation or expected extubation in the next 24h without additional intervention according to judgment of the investigator - Known history of chronic dialysis OR received renal replacement therapy in past 14 days OR anticipated to receive renal replacement therapy within 24h after randomization - Known history of progressed COPD as evidenced by use of daily maintenance treatment with long-acting bronchodilators or inhaled/oral corticosteroids for > 2 months - Treatment of COVID-19 with investigational antibody treatment(s) which are not approved or not included in locally adopted treatment guidelines (e.g., WHO guidance, National Institutes of Health [NIH] COVID-19 treatment guidelines) for this indication in the past 7 days (Note: Antibody treatment[s] given within past 7 days for pre-existing diseases, other than COVID-19, are allowed.) - At time point of randomization, treatment of COVID-19 with investigational treatments which are not approved or not included in locally adopted treatment guidelines for this indication (e.g., WHO guidance, NIH COVID-19 treatment guidelines), including SARS-CoV-2 multiplication inhibitor(s) or immunomodulator(s). (Note: If a locally adopted treatment guideline recommends drugs such as remdesivir, dexamethasone, or anticoagulation, this would be allowed. Adopted guidelines and updates must be documented at study initiation and throughout the conduct of the study.) - Received cytokine adsorption therapy in past 3 days - Known severe congestive heart failure (corresponding to e.g. NYHA Class III-IV, left ventricular ejection fraction <40%) - Known history of chronic liver disease (Child-Pugh B or C)
Trial Details
Identifiers
| Identifier | Owner |
|---|---|
| NCT04333420 | ClinicalTrials.gov: US National Institutes of Health |
| EudraCT2020-001335-28 | European Clinical Trials Database |
| IFX1P2-9 | - |
Organisations
- Sponsors InflaRx
- Affiliations InflaRx
Trial Dates
-
Initiation Dates
Actual : 31 Mar 2020
-
Primary Completion Dates
Planned : 30 Sep 2021
Actual : 31 Oct 2021
-
End Dates
Planned : 31 Dec 2021
Actual : 01 Dec 2021
Other Details
- Design double-blind; multicentre; open; parallel; prospective; randomised
- Phase of Trial Phase II/III
- Location Belgium; Brazil; France; Germany; India; Latin America; Mexico; Netherlands; Peru; Russia; South Africa; USA
- Focus Registrational; Therapeutic Use
Interventions
| Drugs | Route | Formulation | Target |
|---|---|---|---|
| Anticoagulants |
-
|
-
|
-
|
| Baricitinib |
-
|
-
|
-
|
| Dexamethasone |
-
|
-
|
-
|
| Immunomodulators |
-
|
-
|
-
|
| Tocilizumab |
-
|
-
|
-
|
|
Vilobelimab Primary Drug
|
Intravenous | Infusion | Complement C5a |
Phase II: IFX-1 + BSC
Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care Drug: IFX-1 + BSC (Phase II study part: IFX-1 + BSC) Other Name: Vilobelimab + Best Supportive Care
Phase II: BSC
Phase II study part: BSC: Best supportive care Drug: BSC (Phase II study part: BSC) Other Name: Best Supportive Care
Phase III: IFX-1 + SOC
Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care Drug: IFX-1 + SOC (Phase III study part: IFX-1 + SOC) Other Name: Vilobelimab + Standard of Care
Phase III: Placebo + SOC
Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care Drug: Placebo + SOC (Phase III study part: Placebo + SOC) Other Name: Placebo + Standard of Care
Results
Therapeutic efficacy
Updated results from the phase II/III PANAMO trial showed that direct C5a inhibition by vilobelimab resulted in a survival benefit for critically ill COVID-19 Pt without increasing infections. Kaplan-Meier estimates showed a 28-Day mortality rate of 31.7% for Vilo vs 41.6% for Plc [HR 0.67 (95% CI: 0.48, 0.96), p< 0.05] with similar 60-Day results. On Day 8 after 3 infusions, mean vilobelimab trough levels were 21,799.3 to 302,972.1 ng/mL (geometric mean 137,881.3 ng/mL). C5a was highly elevated and comparable between groups at screening. By Day 8, C5a levels were reduced 87% for vilobelimab (mean 16.8 ng/mL, p< 0.001) vs an increase for Plc (mean 129.8 ng/mL). Though post Day 8 sampling was sparse, C5a levels remained elevated for Plc and low for vilobelimab throughout the study [2] Updated results from the phase II/III PANAMO trial demonstrated that vilobelimab significantly reduced mortality at 28 and 60 days in critically ill COVID-19 patients with no increase in infections suggesting the importance of targeting C5a while preserving MAC. The 28-d all-cause mortality was 31.7% with vilobelimab vs 41.6% with placebo (P) (Kaplan-Meier estimates; Cox regression site-stratified, HR 0.73; 95% CI:0.50-1.06; P = 0.094), representing a 23.8% relative mortality reduction. In predefined primary outcome analysis without site stratification, however, vilobelimab significantly reduced mortality at 28 (HR 0.67; 95% CI:0.48-0.96; P = 0.027) and 60 days (HR 0.67; 95% CI:0.48-0.92; P = 0.016). Vilobelimab also significantly reduced 28-d mortality in more severe patients with baseline WHO ordinal scale score of 7 (n = 237, HR 0.62; 95% CI:0.40-0.95; P = 0.028), severe ARDS/PaO2/FiO2 ≤ 100 mmHg (n = 98, HR 0.55; 95% CI:0.30-0.98; P = 0.044) and eGFR < 60 mL/min/1.73m2 (n = 108, HR 0.55; 95% CI:0.31-0.96; P = 0.036) [3] . Previous results from the phase II/III PANAMO trial demonstrated that the vilobelimab treatment resulted in a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo (vilobelimab 31.7% versus placebo 41.6%, p=0.094), which was not statistically significant using site-stratified cox regression analysis as pre-specified in the final statistical analysis plan. The original protocol-specified analysis would have resulted in a statistically significant p-value of 0.027. Additionally, logistic regression analyses of 28-day all-cause mortality resulted in p-values of <0.05 for 3 out of the 4 pre-specified analyses. Importantly, 60-day all-cause mortality, a key secondary endpoint, showed a continued reduction of mortality in the vilobelimab arm [4] . Efficacy data obtained from phase II/III trial indicated relative reduction in 28-day all cause mortality of 43% (vilobelimab 21.2% versus placebo 37.2%, p=0.014, hazard ratio: 0.5) in patients with severe acute respiratory distress syndrome (ARDS) and PaO2/FiO2 <100 (n=98, p=0.044); in intubated patients suffering from one or more additional organ support captured as baseline ordinal scale of 7 (n=237, p=0.028); and in patients with kidney impairment, captured by estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m² (n=108, p=0.036). As per site-stratified Cox regression analysis as pre-specified in the final statistical analysis plan of the study, this was not statistically significant. The statistical analysis method was changed from non-stratified to site-stratified as per the recommendation of the regulatory authorities. In pre-specified subgroup analysis in Western European patients, a 43% of relative reduction in 28-day all cause mortality was detected, when vilobelimab was compared with placebo treatment (n=209, p-value=0.014). The analysis was done in intubated patients suffering from one or more additional organ support. Earlier data from the part II of a phase II/III trials indicated twenty-eight-day all-cause mortality in the vilobelimab treatment group was 13% (2 out of 15) versus 27% (4 out of 15) in the control group. In a vilobelimab treatment group, a higher number of patients with 2 or more comorbidities associated with increased COVID-19 mortality were reported, compared to best supportive care group. In the vilobelimab treatment group fewer patients experienced renal impairment assessed by estimated glomerular filtration rates and more patients showed reversal of blood lymphocytopenia and a greater lowering of lactate dehydrogenase concentrations as a sign of reduction in tissue damage. A temporary, but statistically significant increase of D-dimer levels in the first days following vilobelimab administration was reported, as a potential signal for induction of blood clot lysis. No statistically significant group differences on the relative percentage change from baseline to day five in oxygenation index (defined as PaO2/FiO2 ratio) were detected [5] [6] [7] .
Adverse events
Updated results from the phase II/III PANAMO trial demonstrated that vilobelimab was safe. Serious AEs were 58.9% for vilobelimab and 63.5% for Plc.Treatment-emergent AEs were 90.9% vilobelimab vs 91.0% placebo (P). Infections were comparable: vilobelimab 62.9%, P 59.3%. Infection incidence per 100 Pt days were equal [2] No meningococcal infections were reported. Serious AEs were 58.9% vilobelimab, 63.5% P [3] . Previous results in a part II of a phase II/III trials, being conducted in patients with severely progressed pneumonia associated with COVID-2019 infections, vilobelimab treatment was well tolerated. There was one death in vilobelimab treatment arm after acute ventilator tube complication (leakage), the other death was due to pulmonary failure in patient with history of severe COPD. In the best supportive care group, there were four deaths due to COVID-2019 induced multi-organ failure. Three of these four were due to pulmonary embolisms as an SAE. Adverse events were comparatively lower in vilobelimab group [7] .
Publications
-
Burnett BP, Lim EHT, Vlaar A, Bruin SD, Brouwer M, Habel M, et al. The safety and efficacy advantage of blocking C5a vs C5 in critically ill, COVID-19 patients: Results from PANAMO, a Phase 3 randomized controlled trial. IDW-2023 2023; abstr. 87.
Available from: URL: https://academic.oup.com/ofid/article/10/Supplement_2/ofad500.003/7448162 -
Mourvillier B, Vlaar A, Witzenrath M, Bauer M, Heunks L, Vasquez LH, et al. Randomized, Controlled Phase 3 Study of anti-C5a Vilobelimab's Effect on Mortality in Critically Ill COVID-19 Patients: A Therapy for Viral Pneumonia. IDW-2022 2022; abstr. LB1529.
Available from: URL: https://academic.oup.com/ofid/article/9/Supplement_2/ofac492.1875/6903994 -
InflaRx. InflaRx Announces Encouraging Phase III Topline Results from PANAMO Trial of Vilobelimab in Severe COVID-19 Patients. Media-Rel 2022;.
Media Release -
InflaRx. InflaRx Reports Encouraging Topline Results from the Exploratory Phase II Part of the Adaptive Randomized Phase II/III Trial of IFX-1 in COVID-19. Media-Rel 2020;.
Media Release -
Vlaar AP, Hermans G, Witzenrath M, Van Paassen P, Heunks L, Mourvillier B, et al. Phase 3 RCT of C5a-Specific Vilobelimab in Severe COVID-19 Pneumonia. ERS-2022 2022; abstr. N/A.
Available from: URL: https://erj.ersjournals.com/content/60/suppl_66/4725 -
InflaRx. InflaRx Announces Vilobelimab Phase III Results in Critically Ill COVID-19 Patients Published in The Lancet Respiratory Medicine. Media-Rel 2022;.
Media Release -
Witzenrath M, Vlaar APJ, Bauer M, Annane D, Heunks L, Mourvillier B, et al. Anti-C5a Vilobelimab Reduces All-cause Mortality in Critically Ill COVID-19 Patients and in Those With Severe ARDS: A Phase 3 Randomized Double-blind, Placebo-controlled Study. ATS-2023 2023; abstr. N/A.
Available from: URL: https://www.abstractsonline.com/pp8/#!/10703/presentation/5178 -
Vlaar A, Lim E, Annane D, Witzenrath M, Bauer M, Heunks L, et al. Vilobelimab?s effect on mortality in severe COVID-19 ARDS patients: Phase 3 RCT. ERS-2023 2023; abstr. 786.
Available from: URL: https://live.ersnet.org/ers/ers2023/en-GB/presentation/557504
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
| A Vlaar, MD, PhD | University Amsterdam |
-
|
|
Clinical Research and Development
Winzerlaer Strasse 2
show details
Jena Postcode: 07745 Germany Telephone: +4989414 1897897 korinna.pilz@inflarx.de |
InflaRX GmbH | Germany |
|
Korinna Pilz, MD
+49 89 4141 89 78 Ext: 0
show details
korinna.pilz@inflarx.de |
InflaRx GmbH |
-
|
Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| InflaRx GmbH |
-
|
-
|
| InflaRX GmbH | Jena | Germany |
| InflaRx Site # 0804 | Somerset West | South-Africa |
| InflaRx Site #0101 | Amsterdam | Netherlands |
| InflaRx Site #0102 | Maastricht | Netherlands |
| InflaRx Site #0103 | Amsterdam | Netherlands |
| InflaRx Site #0104 | Enschede | Netherlands |
| InflaRx Site #0106 | Eindhoven | Netherlands |
| InflaRx Site #0201 | Aachen | Germany |
| InflaRx Site #0202 | Berlin | Germany |
| InflaRx Site #0203 | Greifswald | Germany |
| InflaRx Site #0204 | Essen | Germany |
| InflaRx Site #0205 | Hannover | Germany |
| InflaRx Site #0206 | Jena | Germany |
| InflaRx Site #0207 | Augsburg | Germany |
| InflaRx Site #0208 | Dresden | Germany |
| InflaRx Site #0301 | Belo Horizonte | Brazil |
| InflaRx Site #0302 | Campinas | Brazil |
| InflaRx Site #0303 | São José | Brazil |
| InflaRx Site #0304 | Porto Alegre | Brazil |
| InflaRx Site #0305 | Criciúma | Brazil |
| InflaRx Site #0306 | São Paulo | Brazil |
| InflaRx Site #0308 | Curitiba | Brazil |
| InflaRx Site #0501 | Nuevo León | Mexico |
| InflaRx Site #0502 | Chihuahua | Mexico |
| InflaRx Site #0503 | Culiacán | Mexico |
| InflaRx Site #0504 | Monterrey | Mexico |
| InflaRx Site #0505 | Veracruz | Mexico |
| InflaRx Site #0506 | Mérida | Mexico |
| InflaRx Site #0601 | Callao | Peru |
| InflaRx Site #0603 | Lima | Peru |
| InflaRx Site #0604 | Lima | Peru |
| InflaRx Site #0701 | Barnaul | Russia |
| InflaRx Site #0702 | Ryazan' | Russia |
| InflaRx Site #0704 | Moscow | Russia |
| InflaRx Site #1001 | Paris | France |
| InflaRx Site #1002 | Suresnes | France |
| InflaRx Site #1003 | Nice | France |
| InflaRx Site #1004 | Paris | France |
| InflaRx Site #1005 | Nantes | France |
| InflaRx Site #1006 | Paris | France |
| InflaRx Site #1008 | Paris | France |
| InflaRx Site #1009 | Nantes | France |
| InflaRx Site #1011 | Grenoble | France |
| InflaRx Site #1012 | Saint-Étienne | France |
| InflaRx Site #1101 | Yvoir | Belgium |
| InflaRx Site #1102 | Brussels | Belgium |
| InflaRx Site #1104 | Leuven | Belgium |
| InflaRx Site #1106 | Lodelinsart | Belgium |
| InflaRx Site #1107 | Aalst | Belgium |
| University Amsterdam |
-
|
-
|
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 15 Jan 2025 | Other trial event | According to an InflaRx media release, company has announced that the European Commission (EC) has granted marketing authorization under exceptional circumstances for GOHIBIC (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome. The EU approval of GOHIBIC is supported by the previously announced results of the multicenter Phase 3 PANAMO trial. Under the terms of GOHIBIC (vilobelimab)s approval in the EC, InflaRx will provide annual update Updated 14 May 2025 |
| 15 Nov 2024 | Other trial event | According to an InflaRx media release, company anticipates approval of vilobelimab for COVID-19 pneumonia in European Union (IV) in early 2025. Updated 21 Nov 2024 |
| 15 Nov 2024 | Other trial event | According to an InflaRx media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization of GOHIBIC, under exceptional circumstances for patients with SARS-CoV-2-induced ARDS receiving systemic corticosteroids and invasive mechanical ventilation The Company expects the European Commission to adopt the positive opinion and issue a marketing authorization within 67 days. Updated 21 Nov 2024 |
| 08 Nov 2024 | Other trial event | According to an InflaRx media release, in October 2024, the Committee for Medicinal Products for Human Use (CHMP) convened to review the MAA; the regulatory process continues with discussions ongoing between the Company and the CHMP, with a CHMP opinion anticipated around the middle of November. Updated 17 Nov 2024 |
| 21 May 2024 | Other trial event | Results published in the InflaRx media release. Updated 26 Mar 2025 |
| 21 May 2024 | Other trial event | According to an InflaRx media release, the company has presented data at the American Thoracic Society (ATS) 2024 International Conference that is being held from May 17-22, 2024 in San Diego. Updated 26 Mar 2025 |
| 15 Oct 2023 | Results | Results (n=368) assessing safety and efficacy advantage of blocking C5a vs C5 in critically ill, COVID-19 patients presented at the IDWeek 2023 Updated 30 Jan 2024 |
| 13 Sep 2023 | Results | Results assessing mortality worldwide and by region in severe ARDS COVID-19 pt treated withVILOvsP presented at the 33rd Annual Congress of the European Respiratory Society. Updated 26 Mar 2025 |
| 13 Sep 2023 | Other trial event | Last checked against European Clinical Trials Database record. Updated 13 Sep 2023 |
| 12 Sep 2023 | Other trial event | Planned number of patients changed from 390 to 430. Updated 13 Sep 2023 |
| 30 Aug 2023 | Other trial event | According to an InflaRx media release, based upon data from this trial ; the Company has submitted a Marketing Authorization Application (MAA) for the treatment of adult patients with SARS-CoV-2 induced septic ARDS receiving IMV or ECMO and that the European Medicines Agency (EMA) has validated the MAA. This means that the application is now under regulatory review by the European CHMP under the centralized procedure, which applies to all 27 member states of the European Union (EU). Updated 31 Aug 2023 |
| 21 Jun 2023 | Other trial event | According to an InflaRx media release, company is continuing discussions with the FDA related to the submission of a Biologics License Application (BLA) for a potential future full approval of Gohibic. Updated 26 Jun 2023 |
| 07 Jun 2023 | Other trial event | Last checked against the ClinicalTrials.gov record. Updated 07 Jun 2023 |
| 24 May 2023 | Results | Results presented at the 119th International Conference of the American Thoracic Society. Updated 26 Mar 2025 |
| 04 Apr 2023 | Other trial event | According to an InflaRx media release, Emergency Use Authorization (EUA) has been granted by the US Food and Drug Administration (FDA) for Gohibic (vilobelimab) for treatment of coronavirus disease 19 (COVID-19) in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO). Also, Gohibic has not been approved but has been authorized for emergency use by FDA under an EUA. Updated 26 Jun 2023 |
| 04 Apr 2023 | Other trial event | According to an InflaRx media release, company will host a conference call to discuss today's news on Apr 5 at 8:30 am EDT (2:30 pm CEST). Updated 06 Apr 2023 |
| 22 Mar 2023 | Other trial event | According to an InflaRx media release, encouraging results from this trial published in The Lancet Respiratory Medicine. Updated 26 Mar 2025 |
| 23 Oct 2022 | Results | Results presented at the IDWeek 2022. Updated 26 Mar 2025 |
| 29 Sep 2022 | Other trial event | According to an InflaRx media release, the company has submitted a request for Emergency Use Authorization (EUA) following encouraging interactions with the US Food and Drug Administration (FDA) at a Type B meeting held this summer. Updated 13 Oct 2022 |
| 29 Sep 2022 | Other trial event | According to an InflaRx media release, vilobelimab has been granted FDA Fast Track designation to treat critically ill COVID-19 patients based on the results of this study. Updated 05 Oct 2022 |
| 09 Sep 2022 | Other trial event | According to an InflaRx media release, data from this study will be presented at the 35th Annual Congress, European Society for Intensive Care Medicine (ESICM), by Prof. Dr. Alexander Vlaar. Updated 15 Sep 2022 |
| 08 Sep 2022 | Results | According to an InflaRx media release, results from this trial were have been published in the peer-reviewed journal, The Lancet Respiratory Medicine. Updated 31 Aug 2023 |
| 08 Sep 2022 | Results | Results published in the InflaRx Media Release. Updated 12 Sep 2022 |
| 06 Sep 2022 | Results | Results presented at the 32nd Annual Congress of the European Respiratory Society. Updated 26 Mar 2025 |
| 26 Jul 2022 | Other trial event | According to an InflaRx media release, the company plans to submit a request for Emergency Use Authorization (EUA) following encouraging Type B meeting with US FDA. In the meeting with the FDA, the company discussed in detail the completed Phase III part of the PANAMO study in invasively mechanically ventilated, critically ill COVID-19 patients. Application for EUA planned to be submitted in Q3 2022 Updated 27 Jul 2022 |
| 12 May 2022 | Other trial event | According to an InflaRx media release, discussions with regulatory authorities are ongoing to determine next steps towards a potential approval in this indication. Updated 19 May 2022 |
| 31 Mar 2022 | Endpoint not met | Primary endpoint (Phase III: Mortality) has not been met, according to an InflaRx media release. Updated 04 Apr 2022 |
| 31 Mar 2022 | Other trial event | According to an InflaRx media release, the company plans to publish detailed results from this study in a peer-reviewed journal and present the findings at a medical meeting in the coming months. The Company plans to discuss data from the PANAMO study with regulatory authorities in due course. Updated 04 Apr 2022 |
| 31 Mar 2022 | Other trial event | According to an InflaRx media release, the company will host a conference call to discuss the Phase III PANAMO study results today. Updated 04 Apr 2022 |
| 31 Mar 2022 | Results | Results of Phase III part published in an InflaRx Media Release Updated 04 Apr 2022 |
| 24 Mar 2022 | Other trial event | According to an InflaRx media release, topline data for the 28-day mortality primary endpoint is expected to be available by the end of March 2022. Updated 29 Mar 2022 |
| 06 Feb 2022 | Status change - completed | Status changed from active, no longer recruiting to completed. Updated 10 Feb 2022 |
| 13 Jan 2022 | Other trial event | This trial has been completed in Belgium, according to European Clinical Trials Database record. Updated 13 Jan 2022 |
| 11 Jan 2022 | Other trial event | This trial has been completed in Netherlands, according to European Clinical Trials Database record. Updated 12 Jan 2022 |
| 22 Dec 2021 | Other trial event | This trial has been completed in Germany, according to European Clinical Trials Database record. Updated 24 Dec 2021 |
| 12 Oct 2021 | Other trial event | According to an InflaRx media release, topline results are expected to be available in Q1 2022. Updated 15 Oct 2021 |
| 12 Oct 2021 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting, according to an InflaRx media release. Updated 15 Oct 2021 |
| 05 Aug 2021 | Other trial event | According to an InflaRx media release, the option to potentially stop the study early on the basis of efficacy was removed from the interim analysis. Additional trial sites are expected to be added, including in the United States. Updated 12 Aug 2021 |
| 05 Aug 2021 | Other trial event | According to an InflaRx media release, the trial enrollment reaches 299 patients and an independent data monitoring committee has recommended to continue the trial as planned after analyzing data from the first 180 evaluable patients. Updated 12 Aug 2021 |
| 12 May 2021 | Other trial event | According to an InflaRx media release, trial enrollment reaches 178 patients and interim analysis is expected in Q3 2021. Updated 18 May 2021 |
| 11 May 2021 | Completion date | Planned End Date changed from 31 Aug 2021 to 31 Dec 2021. Updated 13 May 2021 |
| 11 May 2021 | Other trial event | Planned primary completion date changed from 31 May 2021 to 30 Sep 2021. Updated 13 May 2021 |
| 25 Mar 2021 | Other trial event | According to an InflaRx media release, topline data from the trial are expected to be available by the end 2021. Updated 31 Mar 2021 |
| 29 Oct 2020 | Results | According to an InflaRx media release, data from the Phase II part of the study were published in the peer-reviewed journal, The Lancet Rheumatology. Updated 03 Nov 2020 |
| 16 Sep 2020 | Completion date | Planned End Date changed from 31 Dec 2020 to 31 Aug 2021. Updated 21 Sep 2020 |
| 16 Sep 2020 | Other trial event | Planned primary completion date changed from 31 Oct 2020 to 31 May 2021. Updated 21 Sep 2020 |
| 14 Sep 2020 | Other trial event | According to an InflaRx media release, Additional sites to be added in the US, EU and other regions Updated 17 Sep 2020 |
| 14 Sep 2020 | Other trial event | According to an InflaRx media release, the phase II results have been accepted for publication in the peer-reviewed journal, The Lancet Rheumatology. Updated 15 Sep 2020 |
| 14 Sep 2020 | Other trial event | According to an InflaRx media release, the company announced today the start of the global Phase III part of this Phase II/III trial with the initiation of the first clinical site in the Netherlands. And, German regulatory authority, the Paul-Ehrlich-Institut (PEI), has approved the Phase III clinical trial in Germany Updated 15 Sep 2020 |
| 04 Sep 2020 | Other trial event | Planned number of patients changed from 130 to 390. Updated 04 Sep 2020 |
| 21 Jul 2020 | Other trial event | According to an InflaRx media release, phase III part of this study is subject to regulatory approval. Updated 23 Jul 2020 |
| 21 Jul 2020 | Other trial event | According to an InflaRx media release, other planned key endpoints for phase III part are assessments of organ support and assessment of disease improvement on the ordinal scale. Updated 23 Jul 2020 |
| 21 Jul 2020 | Other trial event | According to an InflaRx media release, the Company plans to enroll approximately 360 early intubated, critically ill patients with COVID-19 induced pneumonia in phase III part. The company plans to conduct the study at sites in the US, Europe, South America and potentially other regions and an interim analysis is currently planned after enrollment of 180 patients, with the potential for an early stop for efficacy or futility. Updated 23 Jul 2020 |
| 21 Jul 2020 | Other trial event | According to an InflaRx media release, the phase II results have been submitted for publication to a peer-reviewed medical journal along with a preprint server. Updated 23 Jul 2020 |
| 21 Jul 2020 | Other trial event | According to an InflaRx media release, the company will initiate the phase III part in the coming months. Updated 23 Jul 2020 |
| 17 Jun 2020 | Other trial event | According to an InflaRx media release, upon review of the safety data, the independent data safety monitoring board recommended continuation of the trial into the Phase III part. Updated 19 Jun 2020 |
| 17 Jun 2020 | Other trial event | According to an InflaRx media release, data are being prepared for submission to a scientific journal. Updated 19 Jun 2020 |
| 17 Jun 2020 | Interim results | Interim results (n=30) presented in an InflaRx Media Release. Updated 19 Jun 2020 |
| 29 Apr 2020 | Other trial event | According to an InflaRx media release, after all patients have been treated in the first part of the trial, an interim analysis will be performed to assess the clinical benefit of the treatment using the assessed clinical parameters in order to potentially adapt the confirmatory second part of the study. Part 1 is fully enrolled with 30 patients as of April 24, 2020. Additional centers have been opened in the Netherlands, since March 2020. Updated 04 May 2020 |
| 08 Apr 2020 | Other trial event | New source identified and integrated (European Clinical Trials Database; EudraCT2020-001335-28) Updated 08 Apr 2020 |
| 07 Apr 2020 | New trial record | New trial record Updated 07 Apr 2020 |
| 31 Mar 2020 | Other trial event | According to an InflaRx media release, InflaRx has dosed the first patient this study. Updated 07 Apr 2020 |
Table of Contents
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2024;.
Available from: URL: http://clinicaltrials.gov -
Burnett BP, Lim EHT, Vlaar A, Bruin SD, Brouwer M, Habel M, et al. The safety and efficacy advantage of blocking C5a vs C5 in critically ill, COVID-19 patients: Results from PANAMO, a Phase 3 randomized controlled trial. IDW-2023 2023; abstr. 87.
Available from: URL: https://academic.oup.com/ofid/article/10/Supplement_2/ofad500.003/7448162 -
Mourvillier B, Vlaar A, Witzenrath M, Bauer M, Heunks L, Vasquez LH, et al. Randomized, Controlled Phase 3 Study of anti-C5a Vilobelimab's Effect on Mortality in Critically Ill COVID-19 Patients: A Therapy for Viral Pneumonia. IDW-2022 2022; abstr. LB1529.
Available from: URL: https://academic.oup.com/ofid/article/9/Supplement_2/ofac492.1875/6903994 -
InflaRx. InflaRx Reports First Quarter 2022 Financial and Operating Results and Provides Strategic Update. Media-Rel 2022;.
Media Release -
InflaRx. InflaRx Announces Encouraging Phase III Topline Results from PANAMO Trial of Vilobelimab in Severe COVID-19 Patients. Media-Rel 2022;.
Media Release -
InflaRx. InflaRx Announces Decision to Enter Phase III Development of IFX-1 in Severe COVID-19 Induced Pneumonia. Media-Rel 2020;.
Media Release -
InflaRx. InflaRx Reports Encouraging Topline Results from the Exploratory Phase II Part of the Adaptive Randomized Phase II/III Trial of IFX-1 in COVID-19. Media-Rel 2020;.
Media Release -
InflaRx. InflaRx Receives FDA Emergency Use Authorization for Gohibic (vilobelimab) for Treatment of Critically Ill COVID-19 Patients. Media-Rel 2023;.
Media Release -
InflaRx. InflaRx Reports Second Quarter 2021 Financial & Operating Results. Media-Rel 2021;.
Media Release -
InflaRx. InflaRx Receives European Commission Approval for GOHIBIC(Rm) (vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome (ARDS). Media-Rel 2025;.
Media Release -
European Clinical Trials Database. Trial-Reg 2024;.
Available from: URL: https://www.clinicaltrialsregister.eu -
InflaRx. InflaRx Reports Full Year 2022 Financial and Operating Results. Media-Rel 2023;.
Media Release -
InflaRx. InflaRx Announces Commercial Launch of Gohibic (vilobelimab) in the U.S. for the Treatment of Critically Ill COVID-19 Patients. Media-Rel 2023;.
Media Release -
InflaRx. InflaRx's Marketing Authorization Application (MAA) for Vilobelimab for Treatment of Critically Ill COVID-19 Patients under Review by European Medicines Agency (EMA). Media-Rel 2023;.
Media Release -
InflaRx. InflaRx Announces Initiation of Phase III Part of Phase II/III Clinical Trial with IFX-1 in Severe COVID-19 Induced Pneumonia. Media-Rel 2020;.
Media Release -
InflaRx. InflaRx Doses First Patient in Multicenter Randomized Clinical Trial in Severe Progressed COVID-19 Pneumonia in Europe upon Receipt of Initial Positive Human Data with InflaRxs anti-C5a Technology. Media-Rel 2020;.
Media Release -
InflaRx. InflaRx Receives Positive CHMP Opinion for GOHIBIC(Rm) (Vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome. Media-Rel 2024;.
Media Release -
InflaRx. InflaRx Reports Full Year 2019 Financial & Operating Results. Media-Rel 2020;.
Media Release -
InflaRx. InflaRx Submits Request for Emergency Use Authorization to US FDA for Vilobelimab for Treatment of Critically Ill COVID-19 Patients. Media-Rel 2022;.
Media Release -
Vlaar AP, Hermans G, Witzenrath M, Van Paassen P, Heunks L, Mourvillier B, et al. Phase 3 RCT of C5a-Specific Vilobelimab in Severe COVID-19 Pneumonia. ERS-2022 2022; abstr. N/A.
Available from: URL: https://erj.ersjournals.com/content/60/suppl_66/4725 -
InflaRx. InflaRx Reports Full Year 2021 Financial and Operating Results. Media-Rel 2022;.
Media Release -
InflaRx. 09-2020-InflaRx Announces Initiation of Phase III Part of Phase II/III Clinical Trial with IFX-1 in Severe COVID-19 Induced Pneumonia. Media-Rel 2020;.
Media Release -
InflaRx. InflaRx Presents New Analysis of PANAMO Phase III Trial in Severe COVID-19 at ATS 2024 Showing Potential Synergy With Vilobelimab When Used in Combination with Other Immunomodulators. Media-Rel 2024;.
Media Release -
InflaRx. InflaRx Reports First Quarter 2021 Financial & Operating Results. Media-Rel 2021;.
Media Release -
InflaRx. InflaRx Reports Full Year 2020 Financial & Operating Result. Media-Rel 2021;.
Media Release -
InflaRx. InflaRx Announces Plans to Apply for Emergency Use Authorization from the US FDA for Vilobelimab for Treatment of Critically Ill COVID-19 Patients. Media-Rel 2022;.
Media Release -
InflaRx. InflaRx Announces Vilobelimab Phase III Results in Critically Ill COVID-19 Patients Published in The Lancet Respiratory Medicine. Media-Rel 2022;.
Media Release -
InflaRx. InflaRx Completes Enrollment of Vilobelimab Phase III Study in Severe COVID-19. Media-Rel 2021;.
Media Release -
InflaRx. InflaRx to Present at Upcoming Scientific and Investor Conferences. Media-Rel 2022;.
Media Release -
InflaRx. InflaRx Reports Third Quarter 2024 Financial Results and Provides Business Update. Media-Rel 2024;.
Media Release -
Witzenrath M, Vlaar APJ, Bauer M, Annane D, Heunks L, Mourvillier B, et al. Anti-C5a Vilobelimab Reduces All-cause Mortality in Critically Ill COVID-19 Patients and in Those With Severe ARDS: A Phase 3 Randomized Double-blind, Placebo-controlled Study. ATS-2023 2023; abstr. N/A.
Available from: URL: https://www.abstractsonline.com/pp8/#!/10703/presentation/5178 -
InflaRx. InflaRx Reports Q3 2020 Financial & Operating Results. Media-Rel 2020;.
Media Release -
Vlaar A, Lim E, Annane D, Witzenrath M, Bauer M, Heunks L, et al. Vilobelimab?s effect on mortality in severe COVID-19 ARDS patients: Phase 3 RCT. ERS-2023 2023; abstr. 786.
Available from: URL: https://live.ersnet.org/ers/ers2023/en-GB/presentation/557504
Adis International Ltd. Part of Springer Science+Business Media
© Springer Nature Switzerland AG