Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CaCP29, Vilobelimab
IFX-1 · 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...
Top 15 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Upadacitinib, Lutikizumab |
| Incyte Corporation | INCY | 6 | PHASE3 | povorcitinib, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 14 | PHASE3 | Remibrutinib, Secukinumab |
| Sanofi SA Sponsored ADR | SNY | 3 | PHASE2 | Duvakitug, Brivekimig, SAR445399 |
| MoonLake Immunotherapeutics Class A | MLTX | 2 | PHASE3 | Sonelokimab |
| Pfizer Inc. | PFE | 1 | PHASE2 | Ritlecitinib |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Zasocitinib |
| Zura Bio Limited Class A | ZURA | 1 | PHASE2 | Tibulizumab |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | Olatorepatide |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY072 |
| Oruka Therapeutics, Inc. | ORKA | 1 | PHASE2 | ORKA-002 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE1 | SAR447971 |
| Evommune, Inc. | EVMN | 1 | EARLY_PHASE1 | EVO101 |
| Corvus Pharmaceuticals, Inc. | CRVS | 1 | PHASE1 | Soquelitinib |
IFX-1 is an investigational monoclonal antibody developed by InflaRx N.V. (ticker IFRX). It has been studied in Phase 2 clinical trials across several inflammatory conditions, including granulomatosis with polyangiitis, hidradenitis suppurativa, severe COVID-19 pneumonia, and systemic inflammatory response syndrome. It is not an approved therapy.
IFX-1 has been evaluated in clinical trials for granulomatosis with polyangiitis, hidradenitis suppurativa, severe COVID-19 pneumonia, and systemic inflammatory response syndrome. All of these programs were Phase 2 studies, and IFX-1 is not an approved treatment for any indication.
IFX-1 is developed by InflaRx N.V., a biopharmaceutical company whose shares trade under the ticker IFRX. InflaRx has sponsored the Phase 2 clinical trials of IFX-1 in inflammatory and immune-mediated conditions.
IFX-1 is in Phase 2 development. All four of its listed clinical trials were Phase 2 studies, and all have been completed. IFX-1 is investigational and has not been approved by the FDA for any indication.
IFX-1 has been studied in completed Phase 2 trials including NCT04333420 in severe COVID-19 pneumonia, NCT03895801 in granulomatosis with polyangiitis and microscopic polyangiitis, NCT03487276 in hidradenitis suppurativa, and NCT03001622 in hidradenitis suppurativa. These studies were randomized, double-blind, and placebo-controlled.