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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Lutikizumab |
| Incyte Corporation | INCY | 6 | PHASE3 | Povorcitinib |
| Novartis AG Sponsored ADR | NVS | 12 | PHASE3 | secukinumab |
| MoonLake Immunotherapeutics Class A | MLTX | 2 | PHASE3 | Sonelokimab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | Brivekimig |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Eltrekibart |
| 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 Dose A, Tibulizumab Dose B |
| Sonoma Pharmaceuticals, Inc. | SNOA | 2 | PHASE1 | SBT777101 |
| Evommune, Inc. | EVMN | 1 | EARLY_PHASE1 | EVO101 |