Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IFX-1 · 4 trials · 6 indications
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 |
|---|---|---|
| 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 | DRUG | intravenously administered |
| Placebo-IFX-1 | DRUG | intravenously administered |
| Glucocorticoid (GC) | DRUG | orally administered |
| Placebo-Glucocorticoid (Placebo-GC) | DRUG | orally administered |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) * Have ≥ 1 "major" item, or ≥ 3 other items, or ≥ 2 renal items on the Birmingham Vasculitis Activity Score Version 3 (BVASv3). * Newly diagnosed or relapsed GPA or MPA that requires treatmen...
IFX-1 is an investigational small molecule being studied for hidradenitis suppurativa, granulomatosis with polyangiitis, systemic inflammatory response syndrome, and severe COVID-19 pneumonia. It is in Phase 2 clinical development and is not approved by the FDA.
IFX-1 is being developed by InflaRx N.V., a biopharmaceutical company traded on the NASDAQ under the ticker IFRX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in several inflammatory and immune-related conditions.
IFX-1 is in Phase 2 clinical development. It has completed multiple Phase 2 trials, including studies in hidradenitis suppurativa, systemic inflammatory response syndrome, and severe COVID-19 pneumonia. The drug remains investigational and has not received regulatory approval.
IFX-1 has been studied in several completed Phase 2 trials, including NCT02866825 in systemic inflammatory response syndrome, NCT03001622 and NCT03487276 in hidradenitis suppurativa, and NCT04333420 in severe COVID-19 pneumonia. These trials were randomized, double-blind, and placebo-controlled.
IFX-1 is the primary name used for this drug in clinical trials and by its developer, InflaRx N.V. No alternative names have been reported in the clinical trial records or company communications.