Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as IFX-1, CaCP29
vilobelimab · 6 trials · 8 indications
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)
Number and percentage of deaths (all-cause) until Day 28 (FAS)
Number of patients with treatment-emergent adverse events (TEAEs), related TEAEs, serious TEAEs, and adverse events of special interest (AESIs) TEAEs are defined as adverse events that start at or after the first administration of study drug. Related TEAEs are defined as all TEAEs considered by the investigator to have at least a 'possible' relationship with the study drug. AESIs are defined as infusion-related reactions, including acute and delayed hypersensitivity and anaphylactic reactions during or after infusion; Meningitis; Meningococcal septicaemia; Invasive infection. As adverse events will be reported in details in the safety section, no separate reporting on System Organ Class (SOC) or Preferred Term (PT) level etc. is done here.
Efficacy Endpoint: Percentage of subjects achieving clinical response (reduction in Birmingham Vasculitis Activity Score version 3 \[BVASv3\] of ≥50% compared to baseline and no worsening in any body system). Subjects who received rescue therapy after Day 1 or discontinued due to related adverse event, lack of efficacy or progressive disease are considered as non-responders at all subsequent visits. The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity.
The primary efficacy endpoint of the percentage of patients with HiSCR at Week 16 was analyzed using the multiple comparisons procedure-modelling (MCP-Mod) procedure. The definition for response to treatment based on HiSCR relative to Baseline was: at least 50% reduction in abscesses and inflammatory nodule (AN) count (over all anatomical regions) with no increase in number of abscesses and in number of draining fistulas.
| Arm | Type | Description |
|---|---|---|
| Phase II: IFX-1 + BSC | EXPERIMENTAL | Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care |
| Phase II: BSC | OTHER | Phase II study part: BSC: Best supportive care |
| Phase III: IFX-1 + SOC | EXPERIMENTAL | Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care |
| Phase III: Placebo + SOC | PLACEBO_COMPARATOR | Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care |
| vilobelimab 800 mg Q2W | EXPERIMENTAL | Dose finding with a total of 15 doses of vilobelimab. Vilobelimab: IV infusions of vilobelimab diluted in sodium chloride. All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8). Starting at Day 15: Group 1 (N=6) continued to receive vilobelimab 800 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 1600 mg every Q2W. |
| vilobelimab 1600 mg Q2W | EXPERIMENTAL | Dose finding with a total of 15 doses of vilobelimab. Vilobelimab: IV infusions of vilobelimab diluted in sodium chloride. All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8). Starting at Day 15: Group 2 (N=6) received vilobelimab 1600 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 2400 mg every Q2W. |
| vilobelimab 2400 mg Q2W | EXPERIMENTAL | Dose finding with a total of 15 doses of vilobelimab. Vilobelimab: IV infusions of vilobelimab diluted in sodium chloride. All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8). Starting at Day 15: Group 3 (N=7) received vilobelimab 2400 mg every Q2W. |
| Group A Experimental + active comparator | EXPERIMENTAL | IFX-1 + reduced dose GC |
| Group B Placebo + active comparator | ACTIVE_COMPARATOR | Placebo-IFX-1 + standard dose GC |
| Group C Experimental + placebo comparator | PLACEBO_COMPARATOR | IFX-1 + Placebo-GC |
| Cohort 1 | PLACEBO_COMPARATOR | Placebo |
| Cohort 2 | EXPERIMENTAL | Minimum Dose IFX-1 (400 mg Q4W) |
| Cohort 3 | EXPERIMENTAL | Low dose IFX-1 (800 mg Q4W) |
| Cohort 4 | EXPERIMENTAL | Medium Dose IFX-1 (800 mg Q2W) |
| Cohort 5 | EXPERIMENTAL | High Dose IFX-1 (1200 mg Q2W) |
| IFX-1 | OTHER | - |
| Placebo | PLACEBO_COMPARATOR | dose escalating mimicing single i.v. administration of placebo |
| Name | Type | Description |
|---|---|---|
| IFX-1 + BSC | DRUG | Phase II study part: IFX-1 + BSC |
| BSC | DRUG | Phase II study part: BSC |
| IFX-1 + SOC | DRUG | Phase III study part: IFX-1 + SOC |
| Placebo + SOC | DRUG | Phase III study part: Placebo + SOC |
| vilobelimab | DRUG | IV infusions of vilobelimab diluted in sodium chloride. |
| IFX-1 | DRUG | intravenously administered |
| Placebo-IFX-1 | DRUG | intravenously administered |
| Glucocorticoid (GC) | DRUG | orally administered |
| Placebo-Glucocorticoid (Placebo-GC) | DRUG | orally administered |
| Placebo | DRUG | Placebo |
Phase II Inclusion Criteria: * 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) Exclusion Criteria: * Known history of progr...
Vilobelimab is being developed for the treatment of pyoderma gangrenosum, a rare inflammatory skin condition that causes painful, rapidly growing ulcers. It is an investigational therapy and has not been approved for commercial use. InflaRx N.V. holds an orphan drug designation from the FDA for this program.
Vilobelimab targets complement factor C5, a protein in the complement system that drives inflammatory responses. Vilobelimab is a monoclonal antibody that acts as an inhibitor of C5. By binding C5, it is designed to block the complement-mediated inflammation thought to contribute to pyoderma gangrenosum lesions.
Vilobelimab is being developed by InflaRx N.V., a biopharmaceutical company that trades under the ticker IFRX. InflaRx is the sponsor of the clinical program evaluating vilobelimab in pyoderma gangrenosum. The company holds orphan drug designation from the FDA for this indication.
Vilobelimab is in Phase 2 development for pyoderma gangrenosum. The program includes one completed Phase 2 trial. Vilobelimab is investigational and has not been approved by the FDA for any indication. The FDA has granted orphan drug designation for the pyoderma gangrenosum program.
Vilobelimab has been studied in the Phase 2 trial NCT03971643, titled Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum. The trial enrolled 19 patients across the United States, Canada, and Poland, and it is now completed. Participants were adults aged 18 years and older.
Yes, vilobelimab is also known as IFX-1. The Phase 2 trial in pyoderma gangrenosum was conducted under the IFX-1 name, which is reflected in the study title NCT03971643. Both names refer to the same monoclonal antibody developed by InflaRx N.V. for complement C5 inhibition.